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

Launched by UNIVERSITY HOSPITAL, LIMOGES · May 22, 2019

Keywords

ClinConnect Summary

This clinical trial is comparing two different procedures used to remove large non-pedunculated colonic polyps, which are growths in the colon that can potentially become cancerous. The two methods being studied are called Endoscopic Submucosal Dissection (ESD) and Endoscopic Mucosal Resection (EMR). ESD is a more complex procedure that allows for the complete removal of the polyp in one piece, making it easier to analyze for cancer. It has a lower chance of the polyp coming back, but it also carries more risks and costs more than EMR. The trial aims to see which method has a better outcome in terms of polyp recurrence after six months and to evaluate the costs associated with each procedure over three years.

To participate in this trial, patients need to be at least 18 years old and have a specific type of large polyp in their colon. They should also be able to read questionnaires in French. However, not everyone can join; for example, those who have had previous polyp removal attempts or certain health conditions may be excluded. Participants can expect to receive one of the two treatments and will be followed for a period to monitor their health and the effectiveness of the procedure. This study is important because it will help determine the best approach for treating large polyps, which can ultimately improve patient care.

Gender

ALL

Eligibility criteria

• 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