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NCT Number: NCT03962868

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

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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Key information

Conditions

Colonic Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Limoges, Limoges, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental procedure : ESD

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%)

Comparison procedure: WF-piece meal EMR

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).

Primary outcomes

  1. Compare recurrence rate at follow-up colonoscopy

    Time frame: Month 6

    Compare between two groups

Secondary outcomes

  1. Proportion of R0 resection rate

    Time frame: Month 1

    Compare between two groups

  2. Cumulative complications rate after treatment

    Time frame: Month 1

    Compare between two groups

  3. Endoscopic curative resection rate without surgery

    Time frame: Month 36

    Compare between two groups

  4. Quality of life over time

    Time frame: Month 36

    Compare between two groups at Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36

  5. Cost-effectiveness ratio

    Time frame: Month 36

    Compare between two groups

  6. Cost-utility ratio

    Time frame: Month 36

    Compare between two groups

  7. Cumulative surgical referral rate

    Time frame: Month 36

    Compare between two groups

  8. Compare the proportion of technical failure

    Time frame: Day 1

    Compare between two groups

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: RESECT COLON

Important dates

Study start
2019
Primary completion
2021
Study completion
2025
First posted
May 24, 2019
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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