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

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

Tracking Information

• First Submitted Date: November 4, 2016
• First Posted Date: January 13, 2017
• Last Update Posted Date: July 19, 2018
• Actual Study Start Date: June 7, 2018
• Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 12, 2017)

• Technical success rate [ Time Frame: three years ]
• Safety (incidence of complications); [ Time Frame: three years ]
• Local recurrence. [ Time Frame: Four years ]

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03021135 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: January 12, 2017)

• Resection rate en bloc [ Time Frame: three years ]
• Time of resection [ Time Frame: Three years ]
• Sydney resection ratio (characterized by the following equation - lesion size in millimeters divided by the number of fragments) [ Time Frame: Three years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions
• Official Title: Conventional Endoscopic Mucosal Resection (With Submucosal Injection) Versus Underwater Endoscopic Mucosal Resection (Without Submucosal Injection) for Colorectal Non-pedunculated Colorectal Lesions
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Adenoma
• Colorectal Neoplasms

Intervention

• Procedure: Conventional Endoscopic Mucosal Resection
  Conventional Endoscopic Mucosal Resection
  Other Name: EMR
• Procedure: Underwater Endoscopic Mucosal Resection
  Underwater Endoscopic Mucosal Resection
  Other Name: U-EMR

Study Arms

• Active Comparator: Conventional Mucosal Resection
  C-EMR will be made with saline injection with the indigo carmine.
  Intervention: Procedure: Conventional Endoscopic Mucosal Resection
• Experimental: Underwater Mucosal Resection
  UW-EMR will be made after the complete filling of lumen with water.
  Intervention: Procedure: Underwater Endoscopic Mucosal Resection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 12, 2017): 324
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2021
• Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT03021135
• Other Study ID Numbers: NP 941/16
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

• Responsible Party: Instituto do Cancer do Estado de São Paulo
• Study Sponsor: Instituto do Cancer do Estado de São Paulo
• Collaborators: University of Sao Paulo
• Investigators: Not Provided
• PRS Account: Instituto do Cancer do Estado de São Paulo
• Verification Date: July 2018