SPECIAL REPORT
Improving Tissue Manipulation During ESD and EMR Procedures
Lumendi Expands Customer Centric Culture to Integrate Feedback into Product Enhancements New Endoluminal Techniques ESD versus EMR Polyp Removal Managing Complications Associated with Colorectal Submucosal Dissection Future Developments in Endoscopies
Sponsored by
Published by Global Business Media
Better Stabilization, Better Treatment DiLumen is an endoscopic stabilization and tissue manipulation device for more effective treatment of complex therapeutic procedures.
For more information, visit us at www.lumendi.com
SPECIAL REPORT
Improving Tissue Manipulation During ESD and EMR Procedures
Lumendi Expands Customer Centric Culture to Integrate Feedback into Product Enhancements
SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
Contents
New Endoluminal Techniques ESD versus EMR Polyp Removal Managing Complications Associated with Colorectal Submucosal Dissection Future Developments in Endoscopies
Foreword
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Tom Cropper, Editor
Lumendi Expands Customer Centric Culture 3 to Integrate Feedback into Product Enhancements James White, DO, Vice President, Medical Affairs, Lumendi LLC Sponsored by
DiLumen Enhances the ESD Experience Published by Global Business Media
An Organ-Preserving Accessory
Published by Global Business Media
About Endolumenal Intervention
Global Business Media Limited 62 The Street Ashtead Surrey KT21 1AT United Kingdom
New Endoluminal Techniques
Switchboard: +44 (0)1737 850 939 Fax: +44 (0)1737 851 952 Email: info@globalbusinessmedia.org Website: www.globalbusinessmedia.org
Increased Rates of Cancer
Publisher Kevin Bell Business Development Director Marie-Anne Brooks Editor Tom Cropper Senior Project Manager Steve Banks
Tom Cropper, Editor
The Development of Endoscopic Removal
ESD versus EMR Polyp Removal The Move Towards Less Invasive Procedures Endoluminal Mucosal Resection Endoluminal Submucosal Dissection When to Use EMR and ESD
Managing Complications Associated with Colorectal Submucosal Dissection
Production Manager Paul Davies
James Butler, Staff Writer
For further information visit: www.globalbusinessmedia.org
Greater Difficulty
Material in advertisements and promotional features may be considered to represent the views of the advertisers and promoters. The views and opinions expressed in this publication do not necessarily express the views of the Publishers or the Editor. While every care has been taken in the preparation of this publication, neither the Publishers nor the Editor are responsible for such opinions and views or for any inaccuracies in the articles.
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Jo Roth, Staff Writer
Advertising Executives Michael McCarthy Abigail Coombes
The opinions and views expressed in the editorial content in this publication are those of the authors alone and do not necessarily represent the views of any organisation with which they may be associated.
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10
Recent Innovation
Future Developments in Endoscopies
12
Tom Cropper, Editor
The Race for Early Intervention Improved Polyp Removal From Surgery to Endoscopy
References 14
Š 2019. The entire contents of this publication are protected by copyright. Full details are available from the Publishers. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical photocopying, recording or otherwise, without the prior permission of the copyright owner.
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SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
Foreword
C
olonic cancer is having a growing impact on
We will also look at the current challenges
health services. While steps have already
confronting the treatment of colonic cancer. As the
been taken to transition from more invasive
population ages, more people are entering the high
surgeries to less impactful endoluminal procedures,
risk over 50s group. This will have a significant burden
there is plenty of work still to do. In this Report, we’ll
on resources, which is why so much is being invested
look at the urgent challenge of improving tissue
in research and development to expand the use of
manipulation to deliver better outcomes and reduce
endoscopies.
healthcare costs.
Jo Roth then looks at the two main procedures
Our opening article comes from James White, DO
currently in place, Endoluminal Mucosal Resection
Vice President, Medical Affairs, Lumendi LLC. He
(EMR) and Endoluminal Submucosal Dissection
talks about the company’s approach to developing
(ESD). Each has its advantages, but both are limited
advanced endoluminal products such as their
by issues such as visualisation, stability and the risk
Endoluminal Intervention Platform as well as their new
of perforation.
dynamic retraction system. Innovations such as these
As we move into the future, therefore, the goal
facilitate endoluminal procedures which might not
must be to address these challenges and improve
previously have been possible.
awareness and training in the most advanced
We will look more closely at the company’s latest
techniques. We’ll round off the Report by looking at
launch, the Di Lumen DR +, elsewhere in the Report
some of the developments in progress and what they
as we focus on innovative technologies which aim to
can do to improve the detection and treatment of
reduce the invasiveness of endoscopy procedures.
colonic polyps.
Systems such as these provide access to inaccessible locations and reduce the risk of adverse events by creating a more stable therapeutic area.
Tom Cropper Editor
Tom Cropper, has produced articles and reports on various aspects of global business over the past 15 years. He has also worked as a copywriter for some of the largest corporations in the world, including ANZ Bank, ING and KPMG.
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SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
Lumendi Expands Customer Centric Culture to Integrate Feedback into Product Enhancements James White, DO, Vice President, Medical Affairs, Lumendi LLC
Better Stabilization, Better Treatment DiLumen is an endoscopic stabilization and tissue manipulation device for more effective treatment of complex therapeutic procedures. DILUMEN SYSTEM – 130CM
In July 2018a, Lumendi LLC received CE Certification, opening the European market to its DiLumen EIP™ (Endolumenal Intervention Platform) device to help facilitate complex endoscopic interventions. Previously, the company received U.S. FDA 510(k) clearance for this device in December 2016. To date, DiLumen has been used in over 1,000 procedures across the U.S., Europe, and Asia. Since 2016, Lumendi has received six additional FDA clearances, including one for its next generation DiLumen C2™ EIP, which is designed to provide complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment. As a company, Lumendi’s mission is fully dedicated to advancing the state of the art of gastrointestinal (GI) therapy from GI surgeries to incisionless endolumenal procedures. The company culture endeavors to fully integrate its vision with customer needs in order to improve the design of its products based on real-world experience. Clinician involvement has always been paramount in the development of Lumendi’s platform; its first device, DiLumen, was developed by clinicians at Weill Cornell Medical Center in New York. By incorporating physician and surgeon feedback, Lumendi’s engineers can better optimize the platform for their needs as
well as those of patients. This important input has helped improve the utility of the device. Mike Parrilla, Chief Operating Officer, Lumendi, LLC noted: “One of the more recent enhancements implemented is the integration of suture loops on the fore balloon to enable what we call Dynamic Retraction, which was suggested by several of our early users. Another was the modification of the push rod assembly in the fore balloon to streamline navigation of the DiLumen and endoscope in the colon. Both modifications, among others, did not require significant redesign and were incorporated fairly quickly,” he added.
DiLumen Enhances the ESD Experience Dynamic Retraction, or DiLumen +DR, has particular value during Endoscopic Submucosal Dissection (ESD), which has been on the rise for many years in Asia and is now being adopted in Western countries. Because ESD is a very difficult procedure that requires great skill and precision, western doctors have been asking for better tools and techniques that can make the procedure safer and faster. DiLumen +DR provides a mechanism to effectively and dynamically lift tissue with continuous push or pull tissue tension. This results in better visualization of the submucosal plane, resulting in quicker and more precise dissection.
For more information, visit us at www.lumendi.com
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SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
The DiLumen EIP, which is intended for use with any standard colonoscope or gastroscope, is a singleuse, close-fitting sleeve that fits securely over a standard endoscope. As a dual-balloon accessory, the device is indicated to ensure complete positioning of an endoscope during navigation in the large intestine, while assisting with optical visualization, diagnosis, tissue manipulation, and endoscopic treatment
12 AFT FORE BALLOON INFLATED
In April 2018, the US FDA cleared the DiLumen C2™. Similar in design to the DiLumen EIP, the DiLumen C2 incorporates two 6 mm diameter tool channels, which accommodate two independent flexible articulating hand instruments. These instruments are designed to further improve tissue manipulation, cutting and coagulation in a much safer, faster, and simpler method. Recently (August 2019), Lumendi received 510(k) clearance for its DiLumen Ik™ knife, part of a growing platform of accessories that work in conjunction with the second-generation DiLumen C2™ EIP, which is designed to provide complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment. Other DiLumen accessories include: • Ig™ Endolumenal Interventional Grasper, a flexible endoscopic tool intended to grasp and manipulate tissue within the digestive tract under direct endoscopic visualization. • Is™ Endolumenal Interventional Scissors, a sterile, single-use, disposable monopolar
LUMENDI SYSTEM - VIEW 4
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electrosurgical device for mechanical and electrocautery cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. • Im™ Endolumenal Intervention Mount, an ergonomically designed workstation that will support the various accessories and allow the clinician to perform procedures in a more comfortable standing or seated position. Early on, Lumendi realized that navigating an endoscope within the colon while inside a sheath, such as DiLumen, creates a very different experience than the average endoscopist might encounter. Therefore, incorporating users’ feedback was extremely important in improving the navigation experience. Lumendi was able to incorporate several small but impactful changes to DiLumen that resulted in an improved experience for the clinician user. “Clinical feedback is critical in the development and optimization of medical devices,” comments Emre Gorgun, MD, of the Cleveland Clinic. “Being involved in this process and incorporating that
SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
LUMENDI
feedback in the devices we use can have a huge impact on patient care as well as our experience as providers.”
An Organ-Preserving Accessory The DiLumen EIP is used primarily to facilitate organ-preserving interventions, opening the door to more widespread adoption of endolumenal interventions. Importantly, DiLumen creates an isolated Therapeutic Zone (TZ)b within the intestine. The double balloon system stabilizes the target intervention area, limits the impact of fluid and stool on visualization, and flattens the folds so clinicians are better able to execute treatment of isolated segments of the GI tract, thus preserving the need for surgical intervention in many cases.
About Endolumenal Intervention The DiLumen EIP is an innovative technology specifically designed to assist in removing large benign polyps from the colon, often obviating the need for surgical intervention. The new device allows for expansion of a less invasive treatment paradigm. In certain countries like Japan, endolumenal treatment is quite frequent and surgery for benign polyps is virtually nonexistent. While hundreds of thousands of surgeries for benign polyps are performed globally each year, the shift to endolumenal intervention is now gaining momentum in the United States and Europe. Endolumenal intervention is a procedure performed within a hollow organ (like the
gastrointestinal tract) using well-established techniques, such as retraction, dissection and suturing, under endoscopic control. It is different from laparoscopic surgery – which saw rapid adoption in the 1990s – in that it accesses the targeted lesion for therapeutic treatment through a natural orifice, such as the anusc, takes place entirely within the lumen without the need for incisions, and may involve the removal of diseased tissue via the natural orifice. As a result, endolumenal intervention preserves the patient’s anatomy and can significantly help increase patient safety, reduce the need for general anesthesia, increase the number of patients eligible for treatment, significantly shorten hospital stays (often to same day), reduce financial costs, and improve patient outcomes. While there are potential complications with any procedure, they are likely to be less significant with endolumenal intervention than with traditional or laparoscopic surgery.
Better Stabilization, Better Treatment DiLumen is an endoscopic stabilization and tissue manipulation device for more effective treatment of complex therapeutic procedures.
Contact Michael Augsberger, SVP International Lumendi Ltd Address: Abbey Place, 24-28 Easton St, High Wycombe, Buckinghamshire, HP11 1NT England Phone: +44 20 3109 0312 http://www.lumendi.com
References a. DiLumen received CE Certification and identifies DiLumen EIP with the CE Mark to indicate it conforms
with essential requirements of Council Directive 93/42/EEC concerning medical devices. Lumendi’s EU distribution network is currently being developed, with distributors in Italy, Britain, Switzerland, France, Germany and Spain already in place. b. When both balloons are deployed, and inflated, a stable Therapeutic Zone (TZ) is created. This TZ
facilitates more localized insufflation and manipulation of the colon and provides improved access to lesions to enable endoscopists and surgeons to perform precise endolumenal interventions. Once the procedure is complete, the balloons are deflated and removed along with the colonoscope. c. In the gastrointestinal tract, endolumenal treatment should be performed via natural orifices and involves
the use of a camera mounted on the end of a tube or endoscope. It also utilizes small therapy devices such as needles and electrocautery to lift, dissect, control bleeding and remove tissue.
For more information, visit us at www.lumendi.com
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SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
New Endoluminal Techniques Tom Cropper, Staff Writer New endoscopy devices and techniques must evolve to address ongoing problems and reduce the burden on health services.
Colorectal cancer is the
B
than 42,000 people are
ACK IN 2015, a paper hailed the arrival of the ‘super scope era’ as a new generation of flexible endoscopes transformed the field of gastroenterology1. New devices have enabled better visualisation, reduced pain levels and have reduced the need for surgery. Even so, these techniques are not without their problems and, with rates of colonic cancer on the rise, demand is growing for new solutions which can address these problems.
diagnosed with it every
Increased Rates of Cancer
fourth most common type of cancer in the UK and the second biggest cancer killer. More
year and more than nine out of ten cases (94%) occur in people over the age of 50
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Colorectal cancer is the fourth most common type of cancer in the UK and the second biggest cancer killer. More than 42,000 people are diagnosed with it every year and more than nine out of ten cases (94%) occur in people over the age of 502. As the average age of the population grows, therefore, the number of people pushing into high risk groups increases. Projections from the Office of National Statistics (ONS) suggest that, in 50 years’ time, there is likely to be an additional 8.6 million people over the age of 65 in the UK3. The demographic change is being powered firstly by longer life expectancy and secondly by lower fertility rates, which means future populations will have more people in high risk groups for conditions such as colonic cancer. Older patients will have more complex conditions and require ongoing intensive care. The inevitable result is that costs will rise. A recent study found that more resources will be spent on health in the future with a projected 9% of global GDP being dedicated purely to healthcare4. Richer countries are already spending a much higher proportion of their GDP on health. Figures suggest that in 2017 the US was spending over 17% of its GDP on healthcare, up from just 5% in 19605. Demand is already high and is expected to rise. Patients will be requiring more intensive treatment for longer, and budgets which are already tight will be stretched even further. The future quality of care is under threat. If health services cannot
afford the highest standards of care, some people will miss out. Already there are signs of this happening. Life expectancy growth has stalled in many countries including the UK and US due partly to limited spending on healthcare. Politicians can respond by pledging greater investment, but such policies often lack detail and will not necessarily deliver the necessary improvements. Treatments must become more cost effective. This means conditions need to be spotted earlier to avoid future hospital admission. Less invasive procedures, which do not require stays in hospital and have lower complication rates, will be more attractive as long as they can be shown to be as effective as surgery.
The Development of Endoscopic Removal As we’ll see elsewhere in this Report, endoscopic polyp removal procedures can offer a way to remove small and medium sized polyps without resorting to surgery. They improve the wellbeing of patients and reduce the burden on care teams, but current methods are relatively inefficient and struggle in some situations. Problems arise from thin colorectal walls, poor manoeuvrability and submucosal fibrosis among others. The procedure is also highly complicated and requires a high level of expertise to be performed safely. New techniques and devices have evolved to facilitate faster and more effective ESD. A 2017 paper from Hiroya Mizutani et al6, highlights some of these techniques including: •T he pocket creation method: An initial mucosal incision is made after sub mucosal injection. The dissection is performed to make a large pocket in the submucosal layer under the lesion by inserting the endoscope through the initial incision. Additional incisions are made around the lesion and the remaining tissues are dissected. •T raction method: For when visualisation is difficult. The traction method exerts counter traction on the target lesion facilitating submucosal visualisation. This force can be
SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
Better Stabilization, Better Treatment DILUMEN™ SYSTEM WITH DOUBLE BALLOON THERAPEUTIC ZONE, PUSHROD CONTROL HANDLE AND BALLOON INFLATION HANDLE
exerted with snares, clips, strings or grasping forceps. •E xternal forceps: After the mucosal circumferential incision is made, a bending biopsy forceps is held outside of the endoscope. After the bending forceps is delivered to the lesion, it can grasp the edge of the lesion and produce multi-directional traction by pulling, pushing, or bending. •C lip and snare method: Traction can be controlled with a snare that grasps a clip anchored on the edge of the lesion. In the conventional CSM, the snare is delivered to the clip using grasping forceps inserted through the working channel. At the same time, new devices are coming to
market, such as an over tube with a balloon, which can be useful for those lesions which are in an angulated or difficult position. A single or double balloon method can be used to stabilise the area and make it more accessible. However, only a few hospitals are equipped to offer these. Electrosurgical knives with water jet functions provide a more precise cutting line. Using a water jet, these can enable submucosal injection without replacing devices. Evolution is critical. New techniques and devices will enable hospitals to continue delivering ever greater levels of care quality in the face of financial restrictions. Both patients and health services will feel the benefits.
DiLumen is an endoscopic stabilization and tissue manipulation device for more effective treatment of complex therapeutic procedures.
Demand is already high and is expected to rise. Patients will be requiring more intensive treatment for longer, and budgets which are already tight will be stretched even further
For more information, visit us at www.lumendi.com
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SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
ESD versus EMR Polyp Removal Jo Roth, Staff Writer Advances in ESD and EMR procedures have helped to reduce hospital stays and avoid surgery, but they still carry problems which, potentially, can increase risks to patients.
Laparoscopies can be effective, but they are relatively expensive, require a stay in hospital and carry a risk of complications. To offset this, therefore, there has been a move towards endoluminal procedures which keep anatomy intact and gain access through natural orifices
G
ASTROENTEROLOGY HAS evolved in leaps and bounds over the past few years. Procedures have become faster and less invasive allowing for shorter hospital stays and quicker recovery times. Endoluminal Mucosal Resection (EMR) and Endoluminal Submucosal Dissection (ESD) have helped to make this possible. Even so, existing techniques are not without their issues. There is a need for new tools and platforms which make tissue manipulation and dissection easier, faster and safer.
The Move Towards Less Invasive Procedures An aging population and lifestyle issues have contributed to a significant rise in the rates of colonic cancer, especially among younger people. The immediate result of this was a rise in the number of laparoscopies. In the US, one study found that the incidence of surgery for non-malignant polyps in the US rose from 5.9 per 100,000 adults in 2000 to 9.4 in 20097. Laparoscopies can be effective, but they are relatively expensive, require a stay in hospital and carry a risk of complications. To offset this, therefore, there has been a move towards endoluminal procedures which keep anatomy intact and gain access through natural orifices. However, this has always struggled against the complexity of anatomy and limitations of techniques and equipment. Techniques and devices have evolved to improve endoscopies. Two of the most common approaches are Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD). EMR is easier to perform and takes less time than ESD but the ability of ESD to provide en bloc resections of specimens of more than 20mm means momentum is shifting in its favour. However, ESD has a higher risk of complications and takes more time.
Endoluminal Mucosal Resection EMR is divided into those techniques which use an aspiration cap and those which do not. Strip 8 |WWW.HOSPITALREPORTS.EU
biopsy methods rely on single or double channel scope. The lesion is raised off the muscularis propia with a submucosal bleb strangulated by a snare and resected with an electrosurgical snare. When using a double channel scope, submucosal injection is performed as usual and both the snare and grasping forceps are advanced through the channels. The snare is opened to capture the forceps and then closes snugly. The forceps grasp the lesion and pull it gently into the now opened snare. The snare closes and the lesion is resected. Capped procedures include EMRC which require a transparent plastic cup to be fitted to the endoscope. Different sized caps can be used for different sized lesions, with a soft larger 18mm cap being used for lesions which are larger than those which can be removed with a conventional cap. Once the periphery of the lesion has been marked, a submucosal solution is injected into the tissue. The snare is then prelooped into the rim cap’s groove and is used to suck the lesion, with a medium to high vacuum, into the cap. The endoscopist can then close the snare to strangulate the lesion and suction is released. One drawback of EMRC is that it is performed blind and, as such, the lesion is not always sucked into the centre of the cap. EMR can also be especially difficult in areas such as the lower rectum where the correct approach for endoscopes and snares is not always clear. Piecemeal resection has been seen as the best way to eliminate, or at least reduce, the risk of perforation when cutting large polyps, but this adds time to the procedure and recovery. Surgeons also accept the increased risk for residual dysplasia or neoplasm.
Endoluminal Submucosal Dissection ESD first became popular in Japan where results with EMR were deemed to be unsatisfactory. As such, the procedure is more common in Asia while EMR is still more popular in the West. However, that is beginning to change.
SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
Better Stabilization, Better Treatment
DILUMEN C2™GRASPER AND SCISSORS INSTRUMENTS
ESD resects large specimens of early gastric cancer in a single piece. It is commonly used for large lesions which are greater than 2cm in diameter or when lesions are complex or scarred from previous interventions. A standard ESD requires specialist cutting knives including an insulation tipped electrosurgical knife, a hook knife, a needle knife, a flex knife, a flush knife, a triangle tip knife and a fork knife. The procedure is performed with a standard single accessory channel endoscope. First comes the marking of the lesions followed by the incision and submucosal dissection. Various submucosal solutions will be injected and direct resection is performed with the specialist knives. After dissection, the endoscopist performs preventative endoscopic haemostasis for any oozing or exposed vessels As methods become more advanced, this procedure is being seen as an alternative to surgery in dealing with larger lesions and some superficial tumours. The cost can be higher than a conventional polypectomy but it can achieve the removal of lesions which would not be possible with endoluminal polypectomy. It also has a fast recovery time with patients often going home the same day. ESD is useful for a range of procedures, but it does have drawbacks and risks. Because it cuts deeper into the submucosal layer, it comes with an increased risk of perforation, one which is heightened by the limitations of some current tools. They can lack manoeuvrability and may struggle to navigate to complex therapeutic sites. Stability and visualisation can be poor, while multiple polyp dissections will require repeated navigation to the site.
When to Use EMR and ESD Both EMR and ESD have their advantages and disadvantages. EMR is relatively simple to perform, requires fewer tools and has a good track record. However, it struggles to cope with larger lesions which means some patients treated with EMR may require additional surgery. Equally, recurrence rates can be high. A study from Daniela Guerrero Vinsard et al,. suggest that rates with piecemeal dissections can be as high as 24.1%8. ESD, meanwhile, has a lower recurrence rate and is more appropriate for en bloc dissection of larger polyps. Studies suggest that recurrence rates can be as low as 1%9. However, it is a longer procedure and has a higher perforation rate. Both procedures require significant levels of training. Although EMR is perceived to be easier to perform, clinicians may still need to perform as many as 100 EMR procedures before they reach the flatter portion of the learning curve10. However, the learning curve is even longer and steeper with ESD which requires advanced techniques. It can be difficult to gain the necessary expertise in countries such as the US and UK, where EMR is still more popular than ESD, as mentorship may not be readily available. Both ESD and EMR have value and can contribute to the successful management of lesions. Each patient should be treated with the most appropriate technique available for that individual. However, further research is needed to demonstrate the value of ESD, especially in the West and new devices may make both procedures easier and more effective.
DiLumen is an endoscopic stabilization and tissue manipulation device for more effective treatment of complex therapeutic procedures.
For more information, visit us at www.lumendi.com
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SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
Managing Complications Associated with Colorectal Submucosal Dissection James Butler, Staff Writer Polyps are increasingly being removed by endoscopies rather than surgery, but the procedures can still have serious complications.
ESD is a technically challenging procedure. It has a higher learning curve than EMR and requires a high degree of technical skills. Procedures take longer and they require individuals with the specialist expertise needed for such complicated and demanding procedures
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E
NDOCSOPIC SUBMUCOSAL Dissection (ESD) has become increasingly common in recent years and is often preferred to endoscopic mucosal resection (EMR). As a review of ESD procedures states, it has a number of benefits including ‘resectability of various difficult lesion, accurate histologic assessment of specimen, and lower recurrence rate11’. Alongside these, though, come a higher risk of complications. In this article, we’ll examine the main risk factors associated with ESD and how these can be addressed.
Greater Difficulty ESD is a technically challenging procedure. It has a higher learning curve than EMR and requires a high degree of technical skills. Procedures take longer and they require individuals with the specialist expertise needed for such complicated and demanding procedures. This higher degree of difficulty has two consequences. Complications are more likely, and it can be difficult to find individuals with the technical expertise required. The procedure is especially challenging when performed within the colon. It is a tight space to work in and has relatively thin walls which means endoscopes have limited manoeuvrability due to the confined space, folds of the wall and high degree of mobility. All of which leads to a higher risk of procedurerelated complications such as: •B leeding: The most common complication and often the most serious. It can be divided into immediate bleeding which occurs during the procedure and delayed bleeding which manifests itself as melona or bloody stools after the completion of the endoscopic procedure. Immediate bleeding is often minor and does not interfere with the procedure. Delayed bleeding, meanwhile, can be more serious and could lead to haemorrhagic shock.
It most often occurs between two and seven days after the procedure but can be delayed by as much as two weeks. •P erforation: Perforation of the colon wall can occur during the dissection of the polyp. It may be immediately identified by the endoscopic team or delayed. It can develop between 14 and 24 hours after a procedure. The danger can be exacerbated by large tumour size, submucosal fibrosis, a difficult colonic location or a lack of experience on the part of the ESD operator. •P ost ESD Coagulation Syndrome: Coagulation syndrome (CS) results from electrocoagulation injury in the bowel wall after the endoscopy. It manifests itself by the presence of tenderness at the abdomen or rebound tenderness. It will not require surgery and symptoms will usually improve within a day or so. •S tenosis: A narrowing of the colon through which a regular endoscope cannot travel. A recent study found that Patients who underwent total or subtotal circumferential ESD of a rectal tumour had a high risk of stricture formation. Dilation helped to alleviate the stenosis12. These issues hinder the wider application of ESD and often force clinicians to rely on surgical intervention with all the associated risks that entails. They can be addressed by better techniques and devices which resolve some of the key weaknesses of the procedures. The goal of these innovations is relatively simple: to minimise the risks of complications and make ESD more widely applicable. If they succeed, they can improve the outlook for patients and reduce the burden on health services.
Recent Innovation One such innovation could be seen at the 2019 Digestive Disease Week in San Diego, where DiLumendi unveiled its new DiLumendi
SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
DILUMEN™ INFLATION HANDLE
+DR Dynamic Retraction system. The system is designed to facilitate tissue manipulation for easier polyp resection without the need for surgical interventions. The interventional platform deploys two balloons to aid stabilisation of the anatomy and endoscopic tools. It provides a conduit to the therapeutic site through which tools can be easily manoeuvred. The balloons hold the device in place while the endoscope navigates to the therapeutic site. The aft balloon is inflated first to stabilise the endoscope in position. The clinician can then perform a submucosal injection to create a cushion for the polyp. Dissection begins with an incision until a lip between mucosa and sub mucosa has been created. The fore balloon assembly and DR dynamic contraction system, which includes two suture loops, is deployed to the oral side of the polyp. A standard haemostasis clip is then deployed to join the suture to the front edge of the suture. Gentle tension is applied and the mucosal edge is lifted to expose the fibres. Dissection continues under direct visualisation until the polyp is removed. Finally, the polyp is removed
with the platform still in place. It can handle multiple incisions within the same procedures. According to Dr. Peter Johann, CEO of Lumendi, Ltd., “This modification to DiLumen has the potential to revolutionise tissue manipulation during both ESD and EMR. Current methods of retraction for ESD are clunky at best. Some involve anchoring a spring to a clip or using floss and a clip to create counter traction along the oral side of the polyp. Unlike the DiLumen +DR, these other procedures involve significant skills to master, and provide limited capabilities13.” The promise is one of revolution rather than just evolution. It replaces current methods of tissue manipulation for both EMR and ESD with a more elegant, simple and effective process. Advanced tools such as these, together with the creation of a more easily accessible and stable treatment area reduces the complications of procedures and makes it possible to work in harder to reach locations. Innovation is moving fast which means a gap is quickly developing between those health services which can offer the latest solutions and those who cannot.
Better Stabilization, Better Treatment DiLumen is an endoscopic stabilization and tissue manipulation device for more effective treatment of complex therapeutic procedures.
The goal of these innovations is relatively simple: to minimise the risks of complications and make ESD more widely applicable. If they succeed, they can improve the outlook for patients and reduce the burden on health services
For more information, visit us at www.lumendi.com
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SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
Future Developments in Endoscopies Tom Cropper, Editor New technologies are changing the way early stage bowel cancer is diagnosed and treated. How improvements be delivered in the future?
Because bowel cancer is often thought of as being a disease for older people, younger patients are going undiagnosed. A study published in the journal, Colorectal Disease, found that many younger people were more likely to experience non-specific symptoms
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B
OWEL CANCER treatment is evolving r a p i dl y. N ew te c hn o lo gi e s a n d methodologies enhance every step of the process from initial diagnosis to treatment. The goal is to achieve earlier and less invasive endoluminal interventions. To do so, though, services will need to identify ways to overcome their limitations.
The Race for Early Intervention In the battle against colorectal cancer, time is everything. As long as the disease is caught in the early stages, patients tend to have a good prognosis. Those who can be treated without surgical intervention will have a greater chance of a full swift recovery and will be less of a burden on health services. Unfortunately, many patients go undetected in the early stages. Because bowel cancer is often thought of as being a disease for older people, younger patients are going undiagnosed. A study published in the journal, Colorectal Disease, found that many younger people were more likely to experience non-specific symptoms. The study found that they were more likely to present with abdominal pain as an emergency and were less likely to benefit from an early diagnosis. They also experience a longer interval between referral and diagnosis than older patients14. This is a serious problem. If symptoms are being missed, the chances of a full recovery diminish. The only option is for surgery which consumes resources, lengthens recovery times and carries additional risks. The first aim, therefore, is to improve diagnosis, especially for younger patients. Education, better screening and more advanced colonoscopes will all play an important role in ensuring a more timely and accurate detection of polyps. As such, the colonoscopy market is set for rapid expansion. According to Zion Research, the market was approximately USD$1.7bn in 2018. Between 2019 and 2025 it is expected to grow at a CAGR of 5.1% to USD$2.41bn15.
New technologies such as automatic polyp detection solutions draw on Artificial Intelligence (AI) and deep learning to detect polyps which might be missed by conventional colonoscopes. Reducing the miss rate is an important factor in further reducing the onset of colonic cancer. Studies suggest the use of the new devices can increase the number of diminutive adenomas detected as well as the rate of hyperplastic polyps16.
Improved Polyp Removal The next task is to look at the way polyps are removed. The biggest issues are with visualisation, navigating to the therapeutic site, achieving stable positioning of tools and avoiding perforation of the wall. One of the biggest risks is tearing the colon during the procedure. To mitigate this, surgeons will inject a saline solution into the space below the lesion creating a cushion which lifts the polyp and makes it easier to remove safely. Unfortunately, this cushion does not last long. Complex lesions can take 10 to 20 minutes to remove, but saline cushions only last a few minutes. Researchers are looking into new solutions which will make the cushions longer lived. Researchers at MIT are looking into an alternative in which a liquid is injected which turns into a gel once it reaches the tissue. It lasts longer and gives surgeons a larger window to remove the polyp safely17. The shear thinning gel they have created is semi solid under normal conditions but reverts to liquid when a force is applied which means it can be injected as liquid into the tissue, but then quickly forms into a gel. They believe it can create a stable cushion for the polyp for more than an hour, which gives gastroenterologists plenty of time to complete the procedure.
From Surgery to Endoscopy One of the key battlegrounds in the future will be the debate about when to use endoluminal
SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
DILUMEN™ PUSHROD CONTROL HANDLE
procedures rather than surgery. Although the former has been shown to be easier and safer than the latter, surgery is still popular in the West due to the perceived limitations of endoscopies and the difficulty of training enough professionals in the more advanced technique requires for ESD. Much of this revolves around changing perceptions. A paper by Henry H.L. Wu and James E. East argues that surgical transanal endoscopic microsurgeries (TEM) are still perceived as more reliable modalities of treatment in achieving curative resectional surgery and reducing recurrence rates. However, they argue that studies show adverse event rates ‘exceed that of endoscopic therapy for laparoscopic or open resectional surgery with a 30-day mortality at 0.7 % and major postoperative complication rates of 14 %’18.
There is work to do, therefore, to demonstrate the effectiveness of ESD and EMR and to address their limitations. The paper goes on to say that, while a substantial body of opinion believes that ESD should be the future, it is still impossible to overlook its limitations. “When considering ESD as ‘gold standard,’ we cannot overlook its downsides of technical intricacy, prolonged time of procedure and increased chances of perforation and overnight hospital admission,” states the report. These obstacles will have to be overcome. New technologies will be crucial. As we’ve seen in this report, several new devices are coming to market which aim to address the most serious limitations of endoscopic methodologies. If they are successful, opinions will change and ESD will become more accessible, safer and reliable.
Better Stabilization, Better Treatment DiLumen is an endoscopic stabilization and tissue manipulation device for more effective treatment of complex therapeutic procedures.
When considering ESD as ‘gold standard,’ we cannot overlook its downsides of technical intricacy, prolonged time of procedure and increased chances of perforation and overnight hospital admission
For more information, visit us at www.lumendi.com
WWW.HOSPITALREPORTS.EU| 13
SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
References: The Endoscopy Revolution, the Super Scope Era: https://fg.bmj.com/content/6/2/101
1 2
Bowel Cancer Facts and Figures: https://www.bowelcanceruk.org.uk/about-bowel-cancer/bowel-cancer/
3
Living Longer: How Our Population is Changing and Why it Matters: http://bit.ly/2m39izP
4
Global Spending on Healthcare Projected to be $218.6trillion by 2040:
http://www.healthdata.org/news-release/global-spending-health-expected-increase-1828-trillion-worldwide-2040-many-countries 5
The Rising Cost of Health Care: https://www.thebalance.com/causes-of-rising-healthcare-costs-4064878
6
Recent Developments of Techniques and Devices for Colorectal Endoscopic Sub mucosal Dissection:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5719918/ 7
Increasing Rates of Surgery for Patients with Non-Malignant Colorectal Polyps: https://www.gastrojournal.org/article/S0016-5085(18)30014-3/pdf
8
Adenoma Recurrence After Endoscopic Mucosal Resection: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5803001/
9
Colorectal Submucosal Dissection:
https://www.dovepress.com/colorectal-endoscopic-submucosal-dissection-patient-selection-and-spec-peer-reviewed-fulltext-article-CEG 10
Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colon Polyps:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824597/ 11
Management of Complications of Submucosal Dissection: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6453857/#b50-ce-2019-063
12
Risk of Stricture after Submucosal Dissection: https://www.ncbi.nlm.nih.gov/pubmed/26220284
13
Lumendi Brands Exclusive Tissue Manipulation:
https://www.businesswire.com/news/home/20190611005268/en/Lumendi-Brands-Exclusive-Tissue-Manipulation-Feature-Company%E2%80%99s 14
Young Colorectal Cancer Patients are Going Undiagnosed:
https://www.docwirenews.com/hematology-oncology/young-colorectal-cancer-patients-are-going-undiagnosed/ 15
Global Colonoscopy Device Market: http://bit.ly/2o6fbxJ
16
Real Time Automatic Detection System Increases Polyp and Adenoma Detection Rates: https://gut.bmj.com/content/68/10/1813
17
New Material Could Make it Easier to Remove Polyps: http://news.mit.edu/2019/easier-remove-colon-polyps-gel-0730
18
Will Endoscopic Submucosal Dissection Become the Gold Standard? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6353647/
14 |WWW.HOSPITALREPORTS.EU
Better Stabilization, Better Treatment DiLumen is an endoscopic stabilization and tissue manipulation device for more effective treatment of complex therapeutic procedures.
For more information, visit us at www.lumendi.com
SPECIAL REPORT: IMPROVING TISSUE MANIPULATION DURING ESD AND EMR PROCEDURES
Notes:
16 |WWW.HOSPITALREPORTS.EU
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