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NCT03021135 Clinical Trial

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

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03021135
Other study ID # NP 941/16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 7, 2018
Est. completion date January 19, 2022

Study information
Verified date April 2022
Source Instituto do Cancer do Estado de São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date January 19, 2022
Est. primary completion date January 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Conventional Endoscopic Mucosal Resection
Conventional Endoscopic Mucosal Resection
• Underwater Endoscopic Mucosal Resection
Underwater Endoscopic Mucosal Resection

Locations
Country Name City State
Brazil Instituto do Cancer do Estado de Sao Paulo Sao Paulo

Sponsors (2)
Lead Sponsor Collaborator
Instituto do Cancer do Estado de São Paulo University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Technical success rate three years
Primary Safety (incidence of complications); three years
Primary Local recurrence. Four years
Secondary Resection rate en bloc three years
Secondary Time of resection Three years
Secondary Sydney resection ratio (characterized by the following equation - lesion size in millimeters Three years
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