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

Primary Purpose

Colonic Polyps, Rectal Polyps

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Submucosal Injection EMR
Underwater EMR
Sponsored by
California Pacific Medical Center Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Polyps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • California Pacific Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Submucosal Injection EMR

Underwater EMR

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adenoma recurrence rate

Secondary Outcome Measures

Adverse event rate
Procedure time

Full Information

First Posted
October 19, 2012
Last Updated
February 6, 2020
Sponsor
California Pacific Medical Center Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01712048
Brief Title
Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps
Acronym
IvU
Official Title
Submucosal Injection Assisted Endoscopic Resection vs. Underwater EMR for Large Sessile Colorectal Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Pacific Medical Center Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps, Rectal Polyps

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Submucosal Injection EMR
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Underwater EMR
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Submucosal Injection EMR
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Underwater EMR
Intervention Description
Polypectomy is performed under full water emersion without the use of submucosal injection.
Primary Outcome Measure Information:
Title
Adenoma recurrence rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adverse event rate
Time Frame
48 hours
Title
Procedure time
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Binmoeller, M.D.
Organizational Affiliation
California Pacific Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Hamerski, M.D.
Organizational Affiliation
California Pacific Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
13217613
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. doi: 10.1001/archsurg.1955.01270070122021. No abstract available.
Results Reference
background
PubMed Identifier
12085042
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. doi: 10.1067/mge.2002.125362.
Results Reference
background
PubMed Identifier
15775839
Citation
Nelson DB. Techniques for difficult polypectomy. MedGenMed. 2004 Oct 25;6(4):12. No abstract available.
Results Reference
background
PubMed Identifier
9260717
Citation
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.
Results Reference
background
PubMed Identifier
9276699
Citation
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.
Results Reference
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Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps

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