Traction vs. No Traction in Colonic ESD

Study Overview
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Brief Summary
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The goal of this prospective, randomized, controlled trial conducted at Baylor St. Luke's Medical Center is to compare the effectiveness and clinical outcomes of using a traction device in colonic endoscopic submucosal dissection (ESD) to those of using conventional ESD. The investigators of this study hypothesize that use of the traction device will help expedite colonic endoscopic submucosal dissections.

Detailed Description
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Endoscopic submucosal dissection (ESD) is the mainstay for the treatment of complex colorectal polyps particularly those with a higher risk of superficial submucosal invasion. However, colonic ESD is technically difficult given the thin colon wall and difficult locations of lesion. Endoscopic submucosal dissection (ESD) of colonic lesions can be difficult because the thins wall of the colon wall and the lack of submucosal space expansion to the degree seen in the submucosal dissection in the esophagus or the stomach. ESD can be done in a standard fashion with circumferential incision followed by submucosal dissection according to gravity, tunneling methods, pocket methods or traction. Traction is frequently used to expedite submucosal dissection in particularly in tough locations or in fibrotic lesions. Traction assisted ESD is particularly attractive in colonic ESD given the above-mentioned difficulties and the challenge with performing other techniques such as tunneling or pocket formation in fibrotic lesions or lesions over folds. Tissue traction can be applied by several methods including gravity, mucosal tension, water pressure, and adjusting the patient's body position. Traction can also be applied using devices such as clip and line, snare or using additional endoscope. Data regarding the value of traction in colonic ESD is controversial. Despite multiple publications about the efficacy of traction devices in the east, there are few published data from the west. The Sure trac system was recently approved in the US for traction assisted ESD. The system has 2 devices, the primary device comes preloaded with a silicone band, while the secondary device features a clip of the same size as the primary device to apply traction on the opposite wall. Traction with sure trac system, is readily assembled and easily accessible and it is equipped with its own clip for swift implementation, thus expediting the process. The purpose of this research is to compare the effectiveness and safety of the sure trac traction system (Micro Tec endoscopy, USA) to standard ESD without applying traction.

Official Title
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Comparison of the Efficacy of Using a Traction Device in Colonic Endoscopic Submucosal Dissection Versus Conventional ESD: A Randomized Clinical Trial

Conditions
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Gastrointestinal Neoplasm

Intervention / Treatment
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* Procedure: Endoscopic Submucosal Dissection
* Device: Traction Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 18 years old. Patients can provide informed consent. Patient is referred for ESD procedure of colonic neoplastic lesions and with one of the following criteria: A- Lesions with prior resection or with scar at any size. B- Granular lateral spreading tumors (GLST) more than 3 cm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any suspected submucosal invasion such as Paris classification II a +II or lesions with positive non lifting sign. Exclusion Criteria: Patient is < 18 years old. Patient refused and/or unable to provide consent. Patient is a pregnant woman. Lesions with morphology: pedunculated type (Paris IP, Ips). Appendiceal orifice or IC valve lesions. 6. Patients with lesions removed with other techniques besides ESD (like hybrid ESD or submucosal tunneling technique STER and EMR).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized into one of two arms: Conventional ESD, or ESD with traction device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESD with traction device<br>ESD of target lesion will be performed with the assistance of a traction device. | Procedure: Endoscopic Submucosal Dissection<br>* Endoscopic submucosal dissection (ESD) will be the technique used to remove target lesions.<br>Device: Traction Device<br>* Use of traction device to aid in removing target lesions<br>|
| Active Comparator: Control arm<br>ESD of target lesion will be performed without the use of a traction device | Procedure: Endoscopic Submucosal Dissection<br>* Endoscopic submucosal dissection (ESD) will be the technique used to remove target lesions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dissection speed | Length of time to perform endoscopic submucosal dissection by the operator as measured by calculating area of lesion divided by time (cm^2/hours). | Day 1 (procedure day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| En-bloc, R0, and curative resection rates | As collected for each group | Day 1 (procedure day) | 
| Total procedure time | Total procedure time to perform ESD from scope in to scope out | Day 1 (procedure day) | 
| Intraprocedural adverse events | Such as muscularis propria injury and bleeding (related to or not related to the traction devices). | Day 1 (procedure day), up to 48 hours after procedure. | 
| Post-procedural adverse events | As reported per subject follow-ups with the patient within 1 month. | 1 month post-procedure | 
| Abdominal pain | Collected at 1 hour and 24 hours after procedure utilizing the Visual analogue scale (VAS) | 1 hour post-procedure, 24 hours post-procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Submucosal Dissection, Endoscopic Traction