- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02889679
Underwater Resection of Non-pedunculated Colorectal Lesions
Underwater Resection of Non-pedunculated Colorectal Lesions: A Randomized Controlled Trial
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Mather, California, United States, 95655
- Sacramento VA Medical Center (VANCHCS)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Underwater resection
All eligible lesion identified in a patient will be resected by the underwater technique.
Excluded lesions will be resected by standard polypectomy.
|
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.
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.
|
Active Comparator: Conventional 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.
|
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incomplete resection rate (histologic)
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andrew W Yen, MD, VA Northern California Health Care System
Publications and helpful links
General Publications
- 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. Erratum In: Gastroenterology. 2021 Oct;161(4):1347.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-06-00766
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Neoplasms
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Active, not recruitingColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal CancerUnited States
-
NuCana plcCompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States, France, United Kingdom
-
The Queen Elizabeth HospitalNovartis; AmgenCompletedColorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalAustralia
-
Novartis PharmaceuticalsCompletedColorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States
-
ProgenaBiomeRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Cancer Metastatic | Colorectal Carcinoma | Colorectal Adenocarcinoma | Colorectal SarcomaUnited States
-
Pawel KalinskiNational Cancer Institute (NCI)CompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States
-
Jeremy MeyerUniversity Hospital, Geneva; Hôpital Fribourgeois; Spital Biel, SwitzerlandNot yet recruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenoma | Colorectal Adenocarcinoma | Colorectal Polyp | Colorectal Neoplasms Malignant | Colorectal Neoplasms, Benign
-
Bristol-Myers SquibbNovartisActive, not recruitingColorectal Cancer | Colorectal Neoplasm | Colorectal Tumors | Colorectal CarcinomaItaly, United States, Canada, Spain, Argentina, Australia, Belgium, Chile, Czechia, Germany
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Disorders | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Polyp | Colorectal Neoplasms Malignant | Colorectal Adenomatous Polyp | Colorectal Cancer Stage I | Colorectal Adenoma... and other conditionsUnited States, Italy, China, Spain, Japan
Clinical Trials on Underwater resection
-
Instituto do Cancer do Estado de São PauloUniversity of Sao PauloCompletedColorectal Neoplasms | AdenomaBrazil
-
Ningbo No. 1 HospitalRecruitingHaemorrhage | Pedunculated Colorectal PolypsChina
-
Petz Aladar County Teaching HospitalCompletedRheumatoid ArthritisHungary
-
Unity Health TorontoNot yet recruiting10-20mm Colorectal Polyp
-
Ningbo No. 1 HospitalCompleted
-
Polyclinic of the Hospitaller Brothers of St. John...Terminated
-
Vestre Viken Hospital TrustUllevaal University Hospital; Ostfold Hospital Trust; Sahlgrenska University...Not yet recruitingColorectal Cancer | Colorectal Neoplasia | Screening Colonoscopy | Colorectal Cancer Screening | Vasovagal Reaction
-
Instituto Portugues Oncologia de Lisboa Francisco...Not yet recruitingColon Polyp | Adenoma Colon
-
California Pacific Medical Center Research InstituteCompletedColonic Polyps | Rectal PolypsUnited States
-
University of Southern CaliforniaCompleted