Clincosm LogoSign in Get a demo

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

Sponsor
Instituto do Cancer do Estado de São Paulo (Other)
Overall Status
Terminated
CT.gov ID
NCT03021135
Collaborator
University of Sao Paulo (Other)
105
Enrollment
1
Location
2
Arms
43.4
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Conventional Endoscopic Mucosal Resection
  • Procedure: Underwater Endoscopic Mucosal Resection
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Conventional Endoscopic Mucosal Resection (With Submucosal Injection) Versus Underwater Endoscopic Mucosal Resection (Without Submucosal Injection) for Colorectal Non-pedunculated Colorectal Lesions
Actual Study Start Date :
Jun 7, 2018
Actual Primary Completion Date :
Jan 19, 2022
Actual Study Completion Date :
Jan 19, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Technical success rate [three years]

    2. Safety (incidence of complications); [three years]

    3. Local recurrence. [Four years]

    Secondary Outcome Measures

    1. Resection rate en bloc [three years]

    2. Time of resection [Three years]

    3. Sydney resection ratio (characterized by the following equation - lesion size in millimeters divided by the number of fragments) [Three years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto do Cancer do Estado de Sao Paulo Sao Paulo Brazil 01246-000

    Sponsors and Collaborators

    • Instituto do Cancer do Estado de São Paulo
    • University of Sao Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Instituto do Cancer do Estado de São Paulo
    ClinicalTrials.gov Identifier:
    NCT03021135
    Other Study ID Numbers:
    • NP 941/16
    First Posted:
    Jan 13, 2017
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenoma
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Apr 20, 2022