Underwater Resection of Non-pedunculated Colorectal Lesions

NCT02889679 | Completed

• 1 other identifier: 16-06-00766
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Keywords

Colonoscopy; Polypectomy

Outcome Measures

Primary Outcomes (1)

• Incomplete resection rate (histologic)

  24 months

Study Arms (2)

Underwater resection

EXPERIMENTAL

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

Procedure: Underwater resection; Procedure: Standard polypectomy

Conventional resection

ACTIVE COMPARATOR

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.

Procedure: Conventional (gas distended colon) resection; Procedure: Standard polypectomy

Interventions

Underwater resection PROCEDURE

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.

Underwater resection

Conventional (gas distended colon) resection PROCEDURE

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.

Conventional resection

Standard polypectomy PROCEDURE

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.

Conventional resection; Underwater resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• VA Northern California Health Care System: lead

Study Sites (1)

Sacramento VA Medical Center (VANCHCS)

Mather, California, 95655, United States

Location

Related Publications (3)

• 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.

  PMID: 23022496 BACKGROUND

• 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.

  PMID: 22365184 BACKGROUND

• 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.

  PMID: 31628954 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Andrew W Yen, MD

  VA Northern California Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 5, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)