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

June 30, 2023 updated by: Instituto do Cancer do Estado de São Paulo

Conventional Endoscopic Mucosal Resection (With Submucosal Injection) Versus Underwater Endoscopic Mucosal Resection (Without Submucosal Injection) for Colorectal Non-pedunculated Colorectal Lesions

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Mucosal Resection
C-EMR will be made with saline injection with the indigo carmine.
Procedure: Conventional Endoscopic Mucosal Resection
Conventional Endoscopic Mucosal Resection
Other Names:
  • EMR
Experimental: Underwater Mucosal Resection
UW-EMR will be made after the complete filling of lumen with water.
Procedure: Underwater Endoscopic Mucosal Resection
Underwater Endoscopic Mucosal Resection
Other Names:
  • U-EMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Technical success rate
Time Frame: three years
three years
Safety (incidence of complications);
Time Frame: three years
three years
Local recurrence.
Time Frame: Four years
Four years

Secondary Outcome Measures

Outcome Measure
Time Frame
Resection rate en bloc
Time Frame: three years
three years
Time of resection
Time Frame: Three years
Three years
Sydney resection ratio (characterized by the following equation - lesion size in millimeters
Time Frame: Three years
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Collaborators

University of Sao Paulo

Investigators

  • Principal Investigator: Luciano Lenz, PhD, Cancer Institute of the state of São Paulo (ICESP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2018

Primary Completion (Actual)

January 19, 2022

Study Completion (Actual)

January 19, 2022

Study Registration Dates

First Submitted

November 4, 2016

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimated)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP 941/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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