Clinical Trial: Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Submucosal Injection Assisted Endoscopic Resection vs. Underwater EMR for Large Sessile Colorectal Polyps
Brief Summary: 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.
Detailed Summary:
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 o
Sponsor: California Pacific Medical Center Research Institute
Current Primary Outcome: Adenoma recurrence rate [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adverse event rate [ Time Frame: 48 hours ]
- Procedure time [ Time Frame: 24 hours ]
Original Secondary Outcome: Same as current
Information By: California Pacific Medical Center Research Institute
Dates:
Date Received: October 19, 2012
Date Started: September 2012
Date Completion: January 2018
Last Updated: August 23, 2016
Last Verified: August 2016
