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Clinical Trials/NCT03021135
NCT03021135CompletedNot Applicable

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

Instituto do Cancer do Estado de São Paulo2 sites in 1 country105 target enrollmentStarted: June 7, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
105
Locations
2
Primary Endpoint
Local recurrence.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Outcomes

Primary Outcomes

Local recurrence.

Time Frame: Four years

Safety (incidence of complications);

Time Frame: three years

Technical success rate

Time Frame: three years

Secondary Outcomes

  • Time of resection(Three years)
  • Sydney resection ratio (characterized by the following equation - lesion size in millimeters(Three years)
  • Resection rate en bloc(three years)

Investigators

Sponsor
Instituto do Cancer do Estado de São Paulo
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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