Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps

Colonic Polyps Clinical Trial

— IvU  

Official title:

Submucosal Injection Assisted Endoscopic Resection vs. Underwater EMR for Large Sessile Colorectal Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01712048
• Other study ID #: 2012.070-2
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: California Pacific Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Polyps
• Polyps
• Rectal Polyps

Intervention

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.
• Underwater EMR
Polypectomy is performed under full water emersion without the use of submucosal injection.

Locations

Country	Name	City	State
United States	California Pacific Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View Citation

Nelson DB. Techniques for difficult polypectomy. MedGenMed. 2004 Oct 25;6(4):12. Review. — View Citation

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. — View Citation

ROSENBERG N. Submucosal saline wheal as safety factor in fulguration or rectal and sigmoidal polypi. AMA Arch Surg. 1955 Jan;70(1):120-2. — View Citation

Zarchy T. Risk of submucosal saline injection for colonic polypectomy. Gastrointest Endosc. 1997 Jul;46(1):89-90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma recurrence rate		6 months
Secondary	Adverse event rate		48 hours
Secondary	Procedure time		24 hours