Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps
NCT ID: NCT01712048
Last Updated: 2020-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2012-09-30
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
Underwater EMR
Polypectomy is performed under full water emersion without the use of submucosal injection.
Interventions
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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.
Underwater EMR
Polypectomy is performed under full water emersion without the use of submucosal injection.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with lesions showing adenoma invasion into the muscularis propria on EUS.
* Patients without at least one colo-rectal lesions ≥ 20mm.
18 Years
ALL
No
Sponsors
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California Pacific Medical Center Research Institute
OTHER
Responsible Party
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Kenneth Binmoeller
Interventional Endoscopy Program Director
Principal Investigators
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Kenneth Binmoeller, M.D.
Role: PRINCIPAL_INVESTIGATOR
California Pacific Medical Center
Christopher Hamerski, M.D.
Role: STUDY_DIRECTOR
California Pacific Medical Center
Locations
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California Pacific Medical Center
San Francisco, California, United States
Countries
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References
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ROSENBERG N. Submucosal saline wheal as safety factor in fulguration or rectal and sigmoidal polypi. AMA Arch Surg. 1955 Jan;70(1):120-2. doi: 10.1001/archsurg.1955.01270070122021. No abstract available.
Norton ID, Wang L, Levine SA, Burgart LJ, Hofmeister EK, Rumalla A, Gostout CJ, Petersen BT. Efficacy of colonic submucosal saline solution injection for the reduction of iatrogenic thermal injury. Gastrointest Endosc. 2002 Jul;56(1):95-9. doi: 10.1067/mge.2002.125362.
Nelson DB. Techniques for difficult polypectomy. MedGenMed. 2004 Oct 25;6(4):12. No abstract available.
Zarchy T. Risk of submucosal saline injection for colonic polypectomy. Gastrointest Endosc. 1997 Jul;46(1):89-90. doi: 10.1016/s0016-5107(97)70222-0. No abstract available.
Kudo S, Kashida H, Nakajima T, Tamura S, Nakajo K. Endoscopic diagnosis and treatment of early colorectal cancer. World J Surg. 1997 Sep;21(7):694-701. doi: 10.1007/s002689900293.
Other Identifiers
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2012.070-2
Identifier Type: -
Identifier Source: org_study_id
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