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

NCT03021135 | Completed DMC

• 1 other identifier: NP 941/16
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenoma; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (3)

• Technical success rate

  three years

• Safety (incidence of complications);

  three years

• Local recurrence.

  Four years

Secondary Outcomes (3)

• Resection rate en bloc

  three years

• Time of resection

  Three years

• Sydney resection ratio (characterized by the following equation - lesion size in millimeters

  Three years

Study Arms (2)

Conventional Mucosal Resection

ACTIVE COMPARATOR

C-EMR will be made with saline injection with the indigo carmine.

Procedure: Conventional Endoscopic Mucosal Resection

Underwater Mucosal Resection

EXPERIMENTAL

UW-EMR will be made after the complete filling of lumen with water.

Procedure: Underwater Endoscopic Mucosal Resection

Interventions

Conventional Endoscopic Mucosal Resection PROCEDURE

Conventional Endoscopic Mucosal Resection

Also known as: EMR

Conventional Mucosal Resection

Underwater Endoscopic Mucosal Resection PROCEDURE

Underwater Endoscopic Mucosal Resection

Also known as: U-EMR

Underwater Mucosal Resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, 01246-000, Brazil

Location

Related Links

• Results

MeSH Terms

Conditions

Adenoma; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Luciano Lenz, PhD

  Cancer Institute of the state of São Paulo (ICESP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: January 13, 2017
• Study Start: June 7, 2018
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: July 5, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)