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Completed

NCT Number: NCT02889679

Underwater Resection of Non-pedunculated Colorectal Lesions

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sacramento VA Medical Center (VANCHCS)

Mather, California, 95655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Incomplete resection rate (histologic)

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

VA Northern California Health Care System

Fed

Registry information

Official study title

Underwater Resection of Non-pedunculated Colorectal Lesions: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2016
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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