Underwater Resection of Non-pedunculated Colorectal Lesions



Status:Completed
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:September 2016
End Date:October 2018

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

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.

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.

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.
We found this trial at
1
site
10535 Hospital Way
Mather, California 95655
Phone: 916-366-5339
?
mi
from
Mather, CA
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