Traction vs. No Traction in Colonic ESD
March 20, 2026 updated by: Mohamed Othman, MD, Baylor College of Medicine
Comparison of the Efficacy of Using a Traction Device in Colonic Endoscopic Submucosal Dissection Versus Conventional ESD: A Randomized Clinical Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael Mercado, BS
- Phone Number: 713-798-3606
- Email: Michael.Mercado@bcm.edu
Study Contact Backup
- Name: Mai Khalaf, MD
- Phone Number: 713-798-6696
- Email: Mai.Khalaf@bcm.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- Baylor College of Medicine
-
Contact:
- Mohamed O. Othman, MD
- Phone Number: 713-798-0950
- Email: Mohamed.Othman@bcm.edu
-
Houston, Texas, United States, 77030
- Recruiting
- Baylor St. Lukes Medical Center (BSLMC)
-
Contact:
- Michael Mercado
- Phone Number: 7137983606
- Email: Michael.Mercado@bcm.edu
-
Contact:
- Mohamed O. Othman, MD
- Phone Number: 713-798-0950
- Email: Mohamed.Othman@bcm.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ESD with traction device
ESD of target lesion will be performed with the assistance of a traction device.
|
Endoscopic submucosal dissection (ESD) will be the technique used to remove target lesions.
Use of traction device to aid in removing target lesions
|
|
Active Comparator: Control arm
ESD of target lesion will be performed without the use of a traction device
|
Endoscopic submucosal dissection (ESD) will be the technique used to remove target lesions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dissection speed
Time Frame: Day 1 (procedure day)
|
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
Time Frame: Day 1 (procedure day)
|
As collected for each group
|
Day 1 (procedure day)
|
|
Total procedure time
Time Frame: Day 1 (procedure day)
|
Total procedure time to perform ESD from scope in to scope out
|
Day 1 (procedure day)
|
|
Intraprocedural adverse events
Time Frame: Day 1 (procedure day), up to 48 hours after procedure.
|
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
Time Frame: 1 month post-procedure
|
As reported per subject follow-ups with the patient within 1 month.
|
1 month post-procedure
|
|
Abdominal pain
Time Frame: 1 hour post-procedure, 24 hours post-procedure.
|
Collected at 1 hour and 24 hours after procedure utilizing the Visual analogue scale (VAS)
|
1 hour post-procedure, 24 hours post-procedure.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mohamed Othman, MD, Baylor College of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Burgess NG, Bassan MS, McLeod D, Williams SJ, Byth K, Bourke MJ. Deep mural injury and perforation after colonic endoscopic mucosal resection: a new classification and analysis of risk factors. Gut. 2017 Oct;66(10):1779-1789. doi: 10.1136/gutjnl-2015-309848. Epub 2016 Jul 27.
- Tanaka S, Terasaki M, Kanao H, Oka S, Chayama K. Current status and future perspectives of endoscopic submucosal dissection for colorectal tumors. Dig Endosc. 2012 May;24 Suppl 1:73-9. doi: 10.1111/j.1443-1661.2012.01252.x.
- Othman MO, Jawaid SA, Rungta M, Sur N, Dhingra S. Double-balloon endolumenal intervention platform with flexible grasper to expedite colonic endoscopic submucosal dissection. VideoGIE. 2020 Dec 26;6(3):144-146. doi: 10.1016/j.vgie.2020.11.014. eCollection 2021 Mar. No abstract available.
- Tamaru Y, Kuwai T, Miyakawa A, Kanazawa N, Kusunoki R, Shimura H, Uchiyama S, Ishaq S, Kohno H. Efficacy of a Traction Device for Endoscopic Submucosal Dissection Using a Scissor-Type Knife: A Randomized Controlled Trial. Am J Gastroenterol. 2022 Nov 1;117(11):1797-1804. doi: 10.14309/ajg.0000000000002019. Epub 2022 Sep 26.
- Nagata M. Usefulness of underwater endoscopic submucosal dissection in saline solution with a monopolar knife for colorectal tumors (with videos). Gastrointest Endosc. 2018 May;87(5):1345-1353. doi: 10.1016/j.gie.2017.11.032. Epub 2017 Dec 12.
- Yamasaki Y, Takeuchi Y, Uedo N, Kato M, Hamada K, Aoi K, Tonai Y, Matsuura N, Kanesaka T, Yamashina T, Akasaka T, Hanaoka N, Higashino K, Ishihara R, Iishi H. Traction-assisted colonic endoscopic submucosal dissection using clip and line: a feasibility study. Endosc Int Open. 2016 Jan;4(1):E51-5. doi: 10.1055/s-0041-107779. Epub 2015 Nov 30.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2023
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
February 20, 2027
Study Registration Dates
First Submitted
November 27, 2023
First Submitted That Met QC Criteria
November 27, 2023
First Posted (Actual)
December 7, 2023
Study Record Updates
Last Update Posted (Actual)
March 24, 2026
Last Update Submitted That Met QC Criteria
March 20, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastrointestinal Neoplasms
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Minimally Invasive Surgical Procedures
- Diagnostic Techniques, Surgical
- Endoscopy, Gastrointestinal
- Endoscopy, Digestive System
- Diagnostic Techniques, Digestive System
- Endoscopy
- Digestive System Surgical Procedures
- Endoscopic Mucosal Resection
Other Study ID Numbers
- H-53522
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no expected significant increased risk associated with the use of the traction device in ESD beyond what the current standard is for the procedure.
Loss of confidentiality is the only other risk associated with this project.
All measures to ensure patient confidentiality will be employed.
Data will be coded and entered into a password-protected computer.
Only the Principal Investigator and Study Research Coordinators will have access to data with patient identifiers.
There will be no disclosure of a patients protected health information.
Paper copies of the study documents will be created only as needed and only shown to the investigators listed in the study.
Once the study is completed, all paper copies will be destroyed.
If the results of the study are published or used in any presentations, all patient related information will be coded.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.