Underwater Resection of Non-pedunculated Colorectal Lesions

Not Applicable

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Procedure: Underwater resection; Procedure: Conventional (gas distended colon) resection; Procedure: Standard polypectomy

• Registration Number: NCT02889679
• Lead Sponsor: VA Northern California Health Care System

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.

Study Timeline

• Study First Submitted: 2016-08-31
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-02
• Study First Posted: 2016-09-05
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional resection	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.
Underwater resection	Standard polypectomy	All eligible lesion identified in a patient will be resected by the underwater technique. Excluded lesions will be resected by standard polypectomy.
Underwater resection	Underwater resection	All eligible lesion identified in a patient will be resected by the underwater technique. Excluded lesions will be resected by standard polypectomy.
Conventional resection	Conventional (gas distended colon) resection	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.

Primary Outcome Measures

Name	Time	Method
Incomplete resection rate (histologic)	24 months

Trial Locations

Locations (1)

Sacramento VA Medical Center (VANCHCS); 🇺🇸 Mather, California, United States