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

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

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.

Study Overview

• Status: Completed
• Conditions: Colonic Polyps; Rectal Polyps
• Intervention / Treatment: Procedure: Submucosal Injection EMR; Procedure: Underwater EMR

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.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adenoma recurrence rate	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse event rate	48 hours
Procedure time	24 hours

Collaborators and Investigators

• Sponsor: California Pacific Medical Center Research Institute
• Investigators: Principal Investigator: Kenneth Binmoeller, M.D., California Pacific Medical Center; Study Director: Christopher Hamerski, M.D., California Pacific Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: October 19, 2012
• First Submitted That Met QC Criteria: October 19, 2012
• First Posted (Estimate): October 23, 2012

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: 2012.070-2