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Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps (IvU)

This study is currently recruiting participants.
Verified August 2016 by Kenneth Binmoeller, California Pacific Medical Center Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01712048
First Posted: October 23, 2012
Last Update Posted: August 25, 2016
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.
Information provided by (Responsible Party):
Kenneth Binmoeller, California Pacific Medical Center Research Institute
October 19, 2012
October 23, 2012
August 25, 2016
September 2012
September 2017   (Final data collection date for primary outcome measure)
Adenoma recurrence rate [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01712048 on ClinicalTrials.gov Archive Site
  • Adverse event rate [ Time Frame: 48 hours ]
  • Procedure time [ Time Frame: 24 hours ]
Same as current
Not Provided
Not Provided
 
Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps
Submucosal Injection Assisted Endoscopic Resection vs. Underwater EMR for Large Sessile Colorectal Polyps
The aim of this study is to compare the efficacy and safety of two standard methods of polypectomy (polyp removal), submucosal injection-assisted endoscopic mucosal resection (EMR) and full water emersion (without submucosal injection) EMR, for large colorectal polyps.

The endoscopic resection of benign colon polyps (polypectomy) plays a vital role in the prevention of colo-rectal cancer. While, small pedunculated polyps are removed with ease, large flat lesions pose a greater challenge. As a result, special techniques have been developed to assist in the removal of these difficult polyps.

During conventional colonoscopy with polypectomy, the colon lumen is insufflated with air, which flattens polyps and thins the wall of the colon. These two factors increase the risk of procedural complications such as bleeding and perforation. In order to counter these drawbacks a technique, which involves the injection of saline into the submucosal area beneath the polyp, is commonly used for the resection of large flat polyps. Theoretically, the injection creates a "safety cushion" that reduces the risks of accidental ensnarement of the muscularis propria, which can lead to iatrogenic perforation and thermal injury to the deeper tissue layers. However, the submucosal injection technique is cumbersome in patients with particularly large polyps as multiple injections are often necessary, which can blur the line between normal and abnormal tissue.

Water emersion colonoscopy is a well-established alternative to conventional "air" colonoscopy and is in fact preferred by many endoscopists. Studies have shown that using water instead of air decreases the discomfort of colonoscopy, measured by the amount of sedative and pain medication used, time to complete the colonoscopy, and recovery time, and increases cecal intubation rates. Interventional Endoscopy Services (IES) at CPMC has taken the concepts of water emersion colonoscopy one step further in order to developed a novel method of "underwater" EMR. This technique was inspired by the observation that the muscularis propria of the colon retains its native thickness (1-2 mm) and circular configuration during underwater EUS examination. Furthermore, water immersion "floats" mucosal lesions away from the deeper wall layers, eliminating the need for a "safety cushion" created by submucosal injection. One drawback to the underwater technique is that in the case of poor preps, residual feces in the colon is suspended in the water, interfering with visualization. Additionally, the use of water often causes soiling of the gurney as a result of water seepage from the rectum during the procedure, which requires additional sanitary attention during the procedure.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Colonic Polyps
  • Rectal Polyps
  • Procedure: Submucosal Injection EMR
    Selective saline injection is applied to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection. EMR is then performed with a standard snare.
  • Procedure: Underwater EMR
    Polypectomy is performed under full water emersion without the use of submucosal injection.
  • Active Comparator: Submucosal Injection EMR
    For patients who are randomized to the "submucosal injection" arm polypectomy will be performed with selective saline injection to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection.
    Intervention: Procedure: Submucosal Injection EMR
  • Active Comparator: Underwater EMR
    For patients who are randomized to the "underwater" arm polypectomy with water will be performed under full water emersion without the use of submucosal injection.
    Intervention: Procedure: Underwater EMR

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320
January 2018
September 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients age >18 years that are scheduled for endoscopic resection of large colo-rectal lesions who consent to this study.

Exclusion Criteria:

  • Patients unable to provide informed consent.
  • Patients with lesions showing adenoma invasion into the muscularis propria on EUS.
  • Patients without at least one colo-rectal lesions ≥ 20mm.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Kenneth Binmoeller, M.D. 415-600-1151
Contact: Jona Calitis, BS 415-600-1151 CalitiJ@sutterhealth.org
United States
 
 
NCT01712048
2012.070-2
No
Not Provided
Not Provided
Kenneth Binmoeller, California Pacific Medical Center Research Institute
California Pacific Medical Center Research Institute
Not Provided
Principal Investigator: Kenneth Binmoeller, M.D. California Pacific Medical Center
California Pacific Medical Center Research Institute
August 2016

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