Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial (RESECT COLON)

University of Limoges (UL)

Status

Completed

Conditions

Colonic Polyp

Treatments

Procedure: Comparison procedure: WF-piece meal EMR

Procedure: Experimental procedure : ESD

Study type

Interventional

Funder types

Other

Identifiers

NCT03962868

87RI18_0002 (RESECT COLON)

Details and patient eligibility

About

Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2% However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.

Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.

We therefore propose to compare these two endoscopic resection strategies in terms of recurrence rate at 6 months and to estimate the differential cost-effectiveness and cost-utility ratios over a 36-month time horizon.

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient suffering from non-pedunculated polyp suspected larger than 25 mm in the colon
Colon localization beyond 15 cm of the anal margin.
Indication for endoscopic treatment
Patients aged ≥ 18 years old
Patients able to fill in questionnaires written in French

Exclusion criteria

Prior endoscopic resection attempt
Contra-indication to colonoscopy
Contra-indication to general anesthesia
Inability to stop antiplatelet agents and anti-coagulant according to the European Society of Gastro-Intestinal Endoscopy guidelines.
Recurrent adenoma: post-endoscopic or surgical resection
Pregnant or lactating women
Genetic polyposis (Familial Adenomatous Polyposis, Lynch Syndrome, Peutz-Jeghers Syndrome)
Inability to provide informed consent
Patient under legal protection and or deprived of liberty by judicial or administrative decision
Patient already participating in an interventional clinical research protocol
Patient who cannot be followed for the duration of the study
Non-pedunculated polyp ≤ 25 mm
More than one lesion > 25 mm that fulfilled the inclusion criteria
Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris 0-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)
Non granular pseudodepressed Laterally spreading tumors due to the high risk of nonvisible submucosal cancer
Polyp involving the appendice deeply (type 2 or 3 of classification of Toyonaga)
Polyp inside the ileo-caecal valvula
Tattoing under the lesion
Inflammatory Bowel Disease with expected fibrosis (Crohn disease or ulcerative colitis)
Colon localization < 15 cm of the anal margin.
Polyp invading a diverticulum
Pedunculated polyp
Absence of lesion