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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-17

Study Completion Date

2025-03-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Colonic Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Endoscopic submucosal dissection (ESD)

Group Type EXPERIMENTAL

Experimental procedure : ESD

Intervention Type PROCEDURE

ESD is a new endoscopic resection procedure that allows en-bloc resection for large superficial colorectal neoplasms. It used dedicated devices and consists in a deep submucosal dissection under the lesion after surelevation thanks to submucosal fluid injection and mucosal incision all around the lesion. The en bloc resection allows a perfect pathological analysis and a very low risk of recurrence (\<1.5%)

Endoscopic Mucosal Resection (WF-piece meal EMR)

Group Type ACTIVE_COMPARATOR

Comparison procedure: WF-piece meal EMR

Intervention Type PROCEDURE

WF-piece meal EMR is an older endoscopic resection technique. After surelevation of the lesion thanks to fluid submucosal injection, the precancerous lesion is resected in several pieces using a polypectomy snare. At the end of the procedure when macroscopically visible adenoma has been totally resected a snare tip coagulation of the margin of the scar is performed to destroy potential non visible residual adenoma. This procedure is quicker, safer than ESD but result in more recurrent disease (from 10 to 30% for lesions larger than 25 mm).

Interventions

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Experimental procedure : ESD

ESD is a new endoscopic resection procedure that allows en-bloc resection for large superficial colorectal neoplasms. It used dedicated devices and consists in a deep submucosal dissection under the lesion after surelevation thanks to submucosal fluid injection and mucosal incision all around the lesion. The en bloc resection allows a perfect pathological analysis and a very low risk of recurrence (\<1.5%)

Intervention Type PROCEDURE

Comparison procedure: WF-piece meal EMR

WF-piece meal EMR is an older endoscopic resection technique. After surelevation of the lesion thanks to fluid submucosal injection, the precancerous lesion is resected in several pieces using a polypectomy snare. At the end of the procedure when macroscopically visible adenoma has been totally resected a snare tip coagulation of the margin of the scar is performed to destroy potential non visible residual adenoma. This procedure is quicker, safer than ESD but result in more recurrent disease (from 10 to 30% for lesions larger than 25 mm).

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No