Traction vs. No Traction in Colonic ESD
Comparison of the Efficacy of Using a Traction Device in Colonic Endoscopic Submucosal Dissection Versus Conventional ESD: A Randomized Clinical Trial
Baylor College of Medicine
150 participants
Dec 5, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria5
- 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).
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Interventions
Endoscopic submucosal dissection (ESD) will be the technique used to remove target lesions.
Use of traction device to aid in removing target lesions
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06159634