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Underwater Resection of Non-pedunculated Colorectal Lesions

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Underwater resection
Conventional (gas distended colon) resection
Standard polypectomy
Sponsored by
VA Northern California Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Colonoscopy, Polypectomy

Eligibility Criteria

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

Inclusion Criteria:

  • Adult (≥18 years old) male and female patients.
  • Scheduled for outpatient colonoscopy.
  • Patient able to provide informed consent.
  • Benign, small (6-9mm) and large (≥1cm) non-pedunculated colorectal lesions.

Exclusion Criteria:

  • Diminutive (≤5mm) and pedunculated polyps.
  • Lesions suspected of harboring deep submucosal invasion.
  • Patients who decline to participate or are unable to provide informed consent.

Sites / Locations

  • Sacramento VA Medical Center (VANCHCS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Underwater resection

Conventional resection

Arm Description

All eligible lesion identified in a patient will be resected by the underwater technique. Excluded lesions will be resected by standard polypectomy.

All eligible lesion identified in a patient will be resected by the conventional (gas distended colon) resection techniques. Excluded lesions will be resected by standard polypectomy.

Outcomes

Primary Outcome Measures

Incomplete resection rate (histologic)

Secondary Outcome Measures

Full Information

First Posted
August 31, 2016
Last Updated
December 18, 2018
Sponsor
VA Northern California Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT02889679
Brief Title
Underwater Resection of Non-pedunculated Colorectal Lesions
Official Title
Underwater Resection of Non-pedunculated Colorectal Lesions: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Northern California Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare the efficacy of underwater resection (polypectomy) versus conventional polypectomy techniques for small and large colorectal lesions identified during colonoscopy.
Detailed Description
Conventional endoscopic resection of small and large (≥1cm) colorectal lesions is well established and performed with the colon fully distended with gas. Conventional polypectomy is effective, but the rate of incomplete resection is approximately 10%. Incomplete eradication of precancerous lesions contributes to interval colorectal cancer; therefore, alternative techniques for resection that safely and effectively increase the rate of complete resection are important. Underwater resection (UR) of benign colorectal lesions is a novel technique that utilizes the advantages of water aided endoscopic methods and may decrease the incomplete resection rate of small and large non-pedunculated lesions. The investigators propose the hypothesis that small (6-9mm) and large (≥1cm) non-pedunculated neoplastic colorectal lesions resected by UR (partially distended, water filled lumen without submucosal fluid injection), will significantly decrease the incomplete resection rate (IRR) compared to conventional polypectomy performed in a gas distended lumen. Small (6-9mm) and large (≥1cm) non-pedunculated benign neoplastic colorectal lesions identified during screening, surveillance, diagnostic or therapeutic colonoscopy will be randomized to conventional polypectomy (in a gas distended lumen with or without submucosal fluid injection) versus UR (partially distended, water filled lumen without submucosal injection) at the patient level. Small (6-9mm) lesions will be removed with a 9mm firm, thin wire cold snare and large (≥1cm) lesions will be removed by snare electrocautery. Efforts to remove lesions en bloc with a small rim of normal mucosa will be made, although some larger lesions (≥2cm) may require piecemeal resection. Submucosal fluid injection with a solution may be used with conventional techniques for large and/or flat lesions. Post-polypectomy incomplete resection rates will be assessed from 4 quadrant biopsies obtained around the resection site immediately post-resection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Colonoscopy, Polypectomy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Underwater resection
Arm Type
Experimental
Arm Description
All eligible lesion identified in a patient will be resected by the underwater technique. Excluded lesions will be resected by standard polypectomy.
Arm Title
Conventional resection
Arm Type
Active Comparator
Arm Description
All eligible lesion identified in a patient will be resected by the conventional (gas distended colon) resection techniques. Excluded lesions will be resected by standard polypectomy.
Intervention Type
Procedure
Intervention Name(s)
Underwater resection
Intervention Description
Underwater resection of eligible lesions will be performed with air exclusion (air will be suctioned and completely removed) without submucosal injection in a partially collapsed colon lumen filled with water. Water will be infused with the foot pedal to facilitate visualization during UR and there will be no limit to the amount of water infused. Hot and cold resection techniques will be utilized.
Intervention Type
Procedure
Intervention Name(s)
Conventional (gas distended colon) resection
Intervention Description
Conventional polypectomy of eligible lesions will be performed in a gas distended colon. Hot and cold resection techniques will be utilized. Submucosal fluid injection with a solution containing hydroxyethyl starch, dilute epinephrine and a contrast agent may be used with conventional techniques for large (≥1cm) and/or flat lesions. There will be no limit to the amount of submucosal injection used.
Intervention Type
Procedure
Intervention Name(s)
Standard polypectomy
Intervention Description
Standard polypectomy will be performed for diminutive (<6mm), pedunculated and semi-pedunculated lesions that do not fall under the inclusion criteria for the study. These lesions will be removed in a gas distended colon with a 9mm firm, thin wire cold snare or snare electrocautery for large (≥1cm) lesions.
Primary Outcome Measure Information:
Title
Incomplete resection rate (histologic)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (≥18 years old) male and female patients. Scheduled for outpatient colonoscopy. Patient able to provide informed consent. Benign, small (6-9mm) and large (≥1cm) non-pedunculated colorectal lesions. Exclusion Criteria: Diminutive (≤5mm) and pedunculated polyps. Lesions suspected of harboring deep submucosal invasion. Patients who decline to participate or are unable to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew W Yen, MD
Organizational Affiliation
VA Northern California Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sacramento VA Medical Center (VANCHCS)
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23022496
Citation
Pohl H, Srivastava A, Bensen SP, Anderson P, Rothstein RI, Gordon SR, Levy LC, Toor A, Mackenzie TA, Rosch T, Robertson DJ. Incomplete polyp resection during colonoscopy-results of the complete adenoma resection (CARE) study. Gastroenterology. 2013 Jan;144(1):74-80.e1. doi: 10.1053/j.gastro.2012.09.043. Epub 2012 Sep 25. Erratum In: Gastroenterology. 2021 Oct;161(4):1347.
Results Reference
background
PubMed Identifier
22365184
Citation
Binmoeller KF, Weilert F, Shah J, Bhat Y, Kane S. "Underwater" EMR without submucosal injection for large sessile colorectal polyps (with video). Gastrointest Endosc. 2012 May;75(5):1086-91. doi: 10.1016/j.gie.2011.12.022. Epub 2012 Feb 25.
Results Reference
background
PubMed Identifier
31628954
Citation
Yen AW, Leung JW, Wilson MD, Leung FW. Underwater versus conventional endoscopic resection of nondiminutive nonpedunculated colorectal lesions: a prospective randomized controlled trial (with video). Gastrointest Endosc. 2020 Mar;91(3):643-654.e2. doi: 10.1016/j.gie.2019.09.039. Epub 2019 Oct 16.
Results Reference
derived

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Underwater Resection of Non-pedunculated Colorectal Lesions

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