Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps (IvU)
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|ClinicalTrials.gov Identifier: NCT01712048|
Recruitment Status : Recruiting
First Posted : October 23, 2012
Last Update Posted : December 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colonic Polyps Rectal Polyps||Procedure: Submucosal Injection EMR Procedure: Underwater EMR||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Submucosal Injection Assisted Endoscopic Resection vs. Underwater EMR for Large Sessile Colorectal Polyps|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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.
- Adenoma recurrence rate [ Time Frame: 6 months ]
- Adverse event rate [ Time Frame: 48 hours ]
- Procedure time [ Time Frame: 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712048
|Contact: Kenneth Binmoeller, M.D.||415-600-1151|
|Contact: Jona Calitis, BS||415-600-1151||CalitiJ@sutterhealth.org|
|United States, California|
|California Pacific Medical Center||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Kenneth Binmoeller, M.D. 415-600-1151|
|Contact: Jona Calitis, B.S. 415-600-1151 CalitiJ@sutterhealth.org|
|Principal Investigator:||Kenneth Binmoeller, M.D.||California Pacific Medical Center|