Clinical Trial: Effectiveness and Safety of the Endoscopic Removal of Large and Flat Colonic Polyps With LumenR RetractorTM

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Controlled Trial to Evaluate Effectiveness and Safety of the Endoscopic Removal of Large and Flat Colonic Polyps With LumenR RetractorTM (LR) as a Modified Colonic Overtube

Brief Summary:

Colorectal cancer accounted for 142,570 new cancer cases and 51,370 cancer deaths in USA in 2010 and worldwide has become the third most common cancer and second leading cause of cancer related deaths. Colonic adenomatous polyps are known precursors of colorectal cancer and endoscopic removal of the polyps prevents development of colon cancer.

Removal of such large polyps requires special endoscopic techniques-endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), which are more technically difficult to perform, labor intensive, time consuming and carries higher risks of complications (bleeding, perforations, etc.). The purpose of this study is to determine the effectiveness and safety of the LumenR Retractor in performing EMR and ESD. It is hypothesized that the use of this modified colonic overtube will simplify colonoscopic removal of difficult polyps, decrease the time needed to complete the procedure and decrease the rate of complications post endoscopic removal of large and flat colonic.


Detailed Summary:

All patients presented for endoscopic removal of difficult colonic polyps will be eligible for the study based on inclusion and exclusion criteria. All procedures will be explained by the Investigator and all subjects undergoing treatment will review and sign the study Informed Consent prior to the procedure. Each subject will be randomly assigned to two groups, Group 1 and Group 2, and according to the assignment, the LumenR Retractor will be used or not during the procedure.

Patient preparation, including intravenous sedation, will be the same for both Groups.

Group 1: A traditional pediatric colonoscope will be advanced into the colon and endoscopic removal of the polyp will be performed.

Group 2: A traditional pediatric colonoscope with a modified overtube preloaded over the endoscope will be advanced into the colon. After the polyp is reached, the overtube will be advanced forward and expanded around the polyp. Endoscopic removal of the polyp with the use of commercially available graspers and biopsy forceps inserted through the overtube working channels will be performed.

At the conclusion of each procedure, the size of the polyp, total procedure time, amount of CO2 used for colonic insufflation, amount of fluid used for submucosal injection, and any complications, including bleeding and perforation, will be recorded. At the end of the procedure, if necessary, the resulting mucosal defect after lesion removal will be closed with endoscopic clips or endoscopic suturing device.

After completion of procedure, all subjects will be recovered according to standard recovery room protocol and then discharged home or admitted to hospital if necessary. Subjects will be followed a
Sponsor: Mercy Medical Center

Current Primary Outcome:

  • Percentage of successful en block removal of polyps [ Time Frame: 1 year ]
  • Length of time required to remove large and flat colonic polyps [ Time Frame: Day 1 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Amount of carbon dioxide (CO2) gas for colonic insufflation used during procedure [ Time Frame: Day 1 ]
  • Amount of solution used for submucosal injection to lift the polyp [ Time Frame: Day 1 ]
  • Presence of residual polypoid tissue at the site of polypectomy [ Time Frame: 3 months ]
    A colonoscopy will be performed to evaluate the polypectomy site and remove any residual polypoid tissue if found.
  • Safety assessment based on the number of delayed adverse events and complications [ Time Frame: 10 days ]
  • Rate of bleeding during polypectomy [ Time Frame: 1 year ]
    Estimate of rate of bleeding during endoscopic removal of difficult colonic polyps
  • Rate of perforation during polypectomy [ Time Frame: 1 year ]
    To compare rate of perforation during endoscopic removal of difficult colonic polyps


Original Secondary Outcome: Same as current

Information By: Mercy Medical Center

Dates:
Date Received: January 26, 2014
Date Started: May 2013
Date Completion: December 2017
Last Updated: February 15, 2017
Last Verified: February 2017