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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by California Pacific Medical Center Research Institute
Sponsor:
Information provided by (Responsible Party):
Kenneth Binmoeller, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01712048
First received: October 19, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Colonic Polyps
Rectal Polyps
Procedure: Submucosal Injection EMR
Procedure: Underwater EMR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Submucosal Injection Assisted Endoscopic Resection vs. Underwater EMR for Large Sessile Colorectal Polyps

Resource links provided by NLM:


Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • Adenoma recurrence rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event rate [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Procedure time [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: September 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
Procedure: Underwater EMR
Polypectomy is performed under full water emersion without the use of submucosal injection.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712048

Contacts
Contact: Kenneth Binmoeller, M.D. 415-600-1151
Contact: Steve Kane, BS 415-600-1151 kanesd@sutterhealth.org

Locations
United States, California
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Kenneth Binmoeller, M.D.    415-600-1151      
Contact: Steve Kane, B.S.    415-600-1151    kanesd@sutterhealth.org   
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
Principal Investigator: Kenneth Binmoeller, M.D. California Pacific Medical Center
  More Information

Publications:
Responsible Party: Kenneth Binmoeller, Interventional Endoscopy Program Director, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01712048     History of Changes
Other Study ID Numbers: 2012.070-2
Study First Received: October 19, 2012
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colonic Polyps
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 28, 2014