Prospective Single Centre, Post Market, Randomized Controlled Trial to Demonstrate Feasibility, Safety and Efficacy, of a Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection
Baylor College of Medicine
Summary
The goal of this prospective, single centre, 1:1, Post Market, randomized controlled, Investigator Initiated trial, is to compare the feasibility, safety efficacy, and clinical outcomes of colonic endoscopic submucosal dissection (ESD) utilizing a novel rigidizing overtube called Pathfinder® Endoscope Overtube (Neptune Medical, Burlingame California, USA) device in comparison to conventional ESD. The research team hypothesize that with utilizing a novel rigidizing overtube the procedure time including dissection speed and closure time will be faster due to higher scope stability and greater control over the scope tip. Subsequently, the investigators anticipate lower immediate or delayed adverse events.
Description
Endoscopic submucosal dissection (ESD) is preferred resection method for advanced colonic polyp due to its higher rates of en bloc and R0 resection which lead to higher curative resection rate.1 In comparison to gastric ESD, colonic ESD is more challenging due to colonic unique anatomy and configuration. Tumor of size ≥ 50 mm, spreading across ≥ two folds, flexure locations have been described as strong predictors for difficulties during colonic ESD.2 Redundant colon and looping during colonoscopy may preclude successful advancement of the colonoscope and maintaining stable position for comple…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient is ≥ 22 years old. * Patients can provide written 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 proximal to the sigmoid colon. B - Granular lateral spreading tumors (GLST) more than 30mm. 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: * Patient refused and/or unable…
Interventions
- ProcedureEndoscopic Submucosal Dissection
Removal of study eligible lesions per endoscopic submucosal dissection
- DeviceNovel Rigidizing Overtube
Utilization of the Novel Rigidizing Overtube (Pathfinder) to aid in performing colonic endoscopic submucosal dissection
Locations (2)
- Baylor College of MedicineHouston, Texas
- Baylor St. Lukes Medical Center (BSLMC)Houston, Texas