Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions

Not Applicable

Completed

• Conditions: Colorectal Neoplasms; Adenoma
• Interventions: Procedure: Conventional Endoscopic Mucosal Resection; Procedure: Underwater Endoscopic Mucosal Resection

• Registration Number: NCT03021135
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief Summary

Randomized, comparative and prospective study between Conventional Endoscopic Mucosal Resection for the removal of flat or sessile colorectal lesions without previous attempt to resection.

Detailed Description

This prospective randomized trial was conducted in 2 academic services: Instituto do Câncer do Estado de São Paulo and Centro de Diagnóstico em Gastroenterologia, both linked to the University of São Paulo. The clinical study was performed in accordance to the Declaration of Helsinki.

Study Timeline

• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Study Start: 2018-06-07
• Primary Completion: 2022-01-19
• Study Completion: 2022-01-19
• Status Verified: 2022-04
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Patients age >18 years with sessile or flat Colorectal Lesions (measuring between 10 and 40mm), who consent to this study

Exclusion Criteria

• Patients who refuse to participate in the study.
• Patients with pedunculated, depressed or mixed lesions.
• Patients with lesions smaller than 10 mm or larger than 40 mm.
• Patients with lesions that are inflammatory, neuroendocrine or stromal at the pathology.
• Patients with lesions that were submitted to prior attempt to endoscopic resection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Mucosal Resection	Conventional Endoscopic Mucosal Resection	C-EMR will be made with saline injection with the indigo carmine.
Underwater Mucosal Resection	Underwater Endoscopic Mucosal Resection	UW-EMR will be made after the complete filling of lumen with water.

Primary Outcome Measures

Name	Time	Method
Local recurrence.	Four years
Safety (incidence of complications);	three years
Technical success rate	three years

Secondary Outcome Measures

Name	Time	Method
Time of resection	Three years
Sydney resection ratio (characterized by the following equation - lesion size in millimeters	Three years
Resection rate en bloc	three years

Trial Locations

Locations (1)

Instituto do Cancer do Estado de Sao Paulo; 🇧🇷 Sao Paulo, Brazil