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

Colonic Polyp Clinical Trial

— RESECT COLON  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03962868
• Other study ID #: 87RI18_0002 (RESECT COLON)
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: April 28, 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: April 28, 2024
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 lesionInflammatory 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

Related Conditions & MeSH terms

• Adenoma
• Colonic Polyp
• Colonic Polyps

Intervention

Procedure:
• 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%)
• 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).

Locations

Country	Name	City	State
France	University Hospital, Limoges	Limoges
France	Edouard Herriot Hospital	Lyon
France	Jean Mermoz Hospital	Lyon
France	Nancy University Hospital	Nancy
France	Cochin Hospital	Paris
France	Pontchaillou Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare recurrence rate at follow-up colonoscopy	Compare between two groups	Month 6
Secondary	Proportion of R0 resection rate	Compare between two groups	Month 1
Secondary	Cumulative complications rate after treatment	Compare between two groups	Month 1
Secondary	Endoscopic curative resection rate without surgery	Compare between two groups	Month 36
Secondary	Quality of life over time	Compare between two groups at Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36	Month 36
Secondary	Cost-effectiveness ratio	Compare between two groups	Month 36
Secondary	Cost-utility ratio	Compare between two groups	Month 36
Secondary	Cumulative surgical referral rate	Compare between two groups	Month 36
Secondary	Compare the proportion of technical failure	Compare between two groups	Day 1