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

NCT ID: NCT03021135

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-07

Study Completion Date

2022-01-19

Brief Summary

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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

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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.

Conditions

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Adenoma Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Mucosal Resection

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

Group Type ACTIVE_COMPARATOR

Conventional Endoscopic Mucosal Resection

Intervention Type PROCEDURE

Conventional Endoscopic Mucosal Resection

Underwater Mucosal Resection

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

Group Type EXPERIMENTAL

Underwater Endoscopic Mucosal Resection

Intervention Type PROCEDURE

Underwater Endoscopic Mucosal Resection

Interventions

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Conventional Endoscopic Mucosal Resection

Conventional Endoscopic Mucosal Resection

Intervention Type PROCEDURE

Underwater Endoscopic Mucosal Resection

Underwater Endoscopic Mucosal Resection

Intervention Type PROCEDURE

Other Intervention Names

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EMR U-EMR

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role collaborator

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luciano Lenz, PhD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute of the state of São Paulo (ICESP)

Locations

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Instituto do Cancer do Estado de Sao Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

Related Links

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Other Identifiers

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NP 941/16

Identifier Type: -

Identifier Source: org_study_id

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