Status:
RECRUITING
Traction vs. No Traction in Colonic ESD
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Micro-Tech Endoscopy USA
Conditions:
Gastrointestinal Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 end...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06159634
Start Date
December 5 2023
End Date
June 30 2026
Last Update
January 15 2025
Active Locations (2)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030
2
Baylor St. Lukes Medical Center (BSLMC)
Houston, Texas, United States, 77030