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

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ClinicalTrials.gov Identifier: NCT03021135
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo

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
Adenoma Colorectal Neoplasms Procedure: Conventional Endoscopic Mucosal Resection Procedure: Underwater Endoscopic Mucosal Resection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 324 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 : June 7, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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 Name: 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 Name: U-EMR




Primary Outcome Measures :
  1. Technical success rate [ Time Frame: three years ]
  2. Safety (incidence of complications); [ Time Frame: three years ]
  3. Local recurrence. [ Time Frame: Four years ]

Secondary Outcome Measures :
  1. Resection rate en bloc [ Time Frame: three years ]
  2. Time of resection [ Time Frame: Three years ]
  3. Sydney resection ratio (characterized by the following equation - lesion size in millimeters divided by the number of fragments) [ Time Frame: Three years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021135


Locations
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Brazil
Instituto do Cancer do Estado de Sao Paulo Recruiting
Sao Paulo, Brazil, 01246-000
Contact: Fernanda Menezes, Ms    55 11 3893-2211    fernanda.menezes@icesp.org.br   
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
University of Sao Paulo

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Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT03021135     History of Changes
Other Study ID Numbers: NP 941/16
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Colorectal Neoplasms
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