NCT03962868

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 17, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2021

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2025

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

May 22, 2019

Last Update Submit

January 20, 2026

Conditions

Colonic Polyp

Keywords

Colonic Polyplarge non pedunculatedcolonic adenomaEndoscopic submucosal dissectionEndoscopic Mucosal Resection

Outcome Measures

Primary Outcomes (1)

  • Compare recurrence rate at follow-up colonoscopy

    Compare between two groups

    Month 6

Secondary Outcomes (8)

  • Proportion of R0 resection rate

    Month 1

  • Cumulative complications rate after treatment

    Month 1

  • Endoscopic curative resection rate without surgery

    Month 36

  • Quality of life over time

    Month 36

  • Cost-effectiveness ratio

    Month 36

  • +3 more secondary outcomes

Study Arms (2)

Endoscopic submucosal dissection (ESD)

EXPERIMENTAL
Procedure: Experimental procedure : ESD

Endoscopic Mucosal Resection (WF-piece meal EMR)

ACTIVE COMPARATOR
Procedure: Comparison procedure: WF-piece meal EMR

Interventions

Experimental procedure : ESDPROCEDURE

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 submucosal dissection (ESD)
Comparison procedure: WF-piece meal EMRPROCEDURE

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).

Endoscopic Mucosal Resection (WF-piece meal EMR)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Hospital, Limoges

Limoges, France, 87042, France

Location

Jean Mermoz Hospital

Lyon, France, 69008, France

Location

Edouard Herriot Hospital

Lyon, 69437, France

Location

Nancy University Hospital

Nancy, 54500, France

Location

Cochin Hospital

Paris, 75014, France

Location

Pontchaillou Hospital

Rennes, 35033, France

Location

Related Publications (1)

  • Jacques J, Schaefer M, Wallenhorst T, Rosch T, Lepilliez V, Chaussade S, Rivory J, Legros R, Chevaux JB, Leblanc S, Rostain F, Barret M, Albouys J, Belle A, Labrunie A, Preux PM, Lepetit H, Dahan M, Ponchon T, Crepin S, Marais L, Magne J, Pioche M. Endoscopic En Bloc Versus Piecemeal Resection of Large Nonpedunculated Colonic Adenomas : A Randomized Comparative Trial. Ann Intern Med. 2024 Jan;177(1):29-38. doi: 10.7326/M23-1812. Epub 2023 Dec 12.

    PMID: 38079634DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 24, 2019

Study Start

September 17, 2019

Primary Completion

September 28, 2021

Study Completion

March 19, 2025

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)