RecruitingNot ApplicableNCT06159634

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


Sponsor

Baylor College of Medicine

Enrollment

150 participants

Start Date

Dec 5, 2023

Study Type

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

Min Age: 18 Years

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

PROCEDUREEndoscopic Submucosal Dissection

Endoscopic submucosal dissection (ESD) will be the technique used to remove target lesions.

DEVICETraction Device

Use of traction device to aid in removing target lesions


Locations(2)

Baylor College of Medicine

Houston, Texas, United States

Baylor St. Lukes Medical Center (BSLMC)

Houston, Texas, United States

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NCT06159634


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