Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 4, 2016
First Posted Date  ICMJE January 13, 2017
Last Update Posted Date July 19, 2018
Actual Study Start Date  ICMJE June 7, 2018
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT03021135 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adenoma
  • Colorectal Neoplasms
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2017)
324
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03021135
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Yes
Responsible Party Instituto do Cancer do Estado de São Paulo
Study Sponsor  ICMJE Instituto do Cancer do Estado de São Paulo
Collaborators  ICMJE University of Sao Paulo
Investigators  ICMJE Not Provided
PRS Account Instituto do Cancer do Estado de São Paulo
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP