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

What this Trial Is About

Researchers are evaluating the use of a traction device in colonic endoscopic submucosal dissection (ESD) compared to conventional ESD without traction. This study focuses on patients with complex colorectal polyps, particularly those with risks of superficial submucosal invasion. The investigation aims to determine whether the traction device can help speed up the ESD procedure and improve clinical outcomes, addressing challenges posed by the thin colon wall and difficult lesion locations. The trial is a prospective, randomized, controlled study conducted at Baylor St. Luke's Medical Center. Participants will be randomly assigned to one of two groups. One group will receive ESD with the assistance of a traction device called the Sure trac system, which includes a silicone band and a clip to apply traction, designed to facilitate the dissection process. The other group will undergo standard ESD without any traction device. Both procedures involve removing target colonic lesions using endoscopic submucosal dissection techniques. The study compares the effectiveness and safety of these approaches. During the procedure day, researchers will measure the speed of dissection, total procedure time, and rates of complete lesion removal. They will also monitor for adverse events during and up to 48 hours after the procedure, as well as one month afterward. Abdominal pain will be assessed one hour and 24 hours post-procedure. Participants will undergo these evaluations as part of the study, which continues until February 2027 to collect and analyze these clinical outcomes.

Traction vs. No Traction in Colonic ESD