Comparing traction and no traction in colonic endoscopic submucosal dissection

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

This study is testing if using a traction device during a specific type of colon surgery can help patients have quicker and easier procedures compared to standard methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Baylor College of Medicine (Academic / other)
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT06159634 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of using a traction device during colonic endoscopic submucosal dissection (ESD) compared to conventional ESD techniques. Conducted at Baylor St. Luke's Medical Center, the study will involve a prospective, randomized, controlled design to assess clinical outcomes and procedural efficiency. The hypothesis is that traction will facilitate quicker dissections, particularly in challenging cases such as fibrotic lesions or those located in difficult anatomical positions. The trial will include patients with specific types of colonic neoplastic lesions who meet the eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are referred for ESD procedures for specific types of colonic neoplastic lesions.

Not a fit: Patients with pedunculated lesions or those who cannot provide informed consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and faster procedures for patients undergoing ESD for complex colorectal polyps.

How similar studies have performed: While traction devices have shown promise in ESD in Eastern studies, data from Western populations is limited, making this approach somewhat novel.

Eligibility criteria

Inclusion Criteria:

1. Patient is ≥ 18 years old.
2. Patients can provide informed consent.
3. 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:

1. Patient is \< 18 years old.
2. Patient refused and/or unable to provide consent.
3. Patient is a pregnant woman.
4. Lesions with morphology: pedunculated type (Paris IP, Ips).
5. 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).

Where this trial is running

Houston, Texas and 1 other locations

• Baylor College of Medicine — Houston, Texas, United States (Recruiting)
• Baylor St. Lukes Medical Center (BSLMC) — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Mohamed Othman, MD — Baylor College of Medicine
• Study coordinator: Mai Khalaf, MD

Conditions Gastrointestinal Neoplasm; Endoscopic Submucosal Dissection; Endoscopic Traction