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Underwater Resection of Non-pedunculated Colorectal Lesions

NCT02889679 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2018-12-20

No results posted yet for this study

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

Interventions

PROCEDURE

Underwater resection

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.

PROCEDURE

Conventional (gas distended colon) resection

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.

PROCEDURE

Standard polypectomy

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.

Sponsors & Collaborators

  • VA Northern California Health Care System

    lead FED

Principal Investigators

  • Andrew W Yen, MD · VA Northern California Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02889679 on ClinicalTrials.gov