Complete Histologic Resection of Adenomatous Polyps? (CARE)
Complete Histologic Resection of Adenomatous Polyps? (Complete Adenoma REsection Trial - CARE Trial)
Sponsor: Dartmouth-Hitchcock Medical Center
This observational or N/A phase trial investigates Adenomatous Polyps and is currently completed. Dartmouth-Hitchcock Medical Center leads this study, which shows 14 recorded versions since 2008 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)All patients who present for a colonoscopy and meet inclusion and exclusion criteria will be asked to participate, and all patients with resectable polyps will be included. See also inclusion and exclusion criteria. All patients will have undergone a regular bowel preparation with polyethylene glycol lavage with 4-6 L until clear rectal fluid is evacuated. Polyp resection will be performed by experienced endoscopists (each with over 500 colonoscopies performed). All polyps between 5 and 20mm will be removed with an electro-cautery snare. Polyp size will be estimated using the snare catheter (2.5mm) or the snare diameter (10x20mm, 15x30mm, 20x20mm) before resection. The endoscopist will grade the difficulty of resection. Following the resection, the endoscopist will closely examine the resection margins. Biopsies will be taken from resection margins: 2 biopsies will be obtained from opposite margins for polyps 5-9mm, and 4 biopsies will be taken for polyps 10-20mm from all four quadrants of the resection margins. In case of assumed incomplete resection this will be documented and further (piecemeal) resections should be done, if this is not feasible, margins can be cauterized according to standard polypectomy resection (e.g. by argon beamer coagulation) after previous biopsy. Only those polyps that are found...
All patients who present for a colonoscopy and meet inclusion and exclusion criteria will be asked to participate, and all patients with resectable polyps will be included. See also inclusion and exclusion criteria.
All patients will have undergone a regular bowel preparation with polyethylene glycol lavage with 4-6 L until clear rectal fluid is evacuated.
Polyp resection will be performed by experienced endoscopists (each with over 500 colonoscopies performed). All polyps between 5 and 20mm will be removed with an electro-cautery snare. Polyp size will be estimated using the snare catheter (2.5mm) or the snare diameter (10x20mm, 15x30mm, 20x20mm) before resection. The endoscopist will grade the difficulty of resection. Following the resection, the endoscopist will closely examine the resection margins. Biopsies will be taken from resection margins: 2 biopsies will be obtained from opposite margins for polyps 5-9mm, and 4 biopsies will be taken for polyps 10-20mm from all four quadrants of the resection margins. In case of assumed incomplete resection this will be documented and further (piecemeal) resections should be done, if this is not feasible, margins can be cauterized according to standard polypectomy resection (e.g. by argon beamer coagulation) after previous biopsy. Only those polyps that are found to be adenomatous polyps will be included in the analysis.
If polyp resection is complicated by bleeding (not self-sustained), no biopsies will be taken and any additional polyps that will be found during the remaining examination will be excluded from analysis. Any bleeding from the margins after polypectomy will be treated by endoscopic injection using diluted epinephrine (1:10.000).
A single research subject may have many eligible polyps. To avoid taking many biopsies, the investigators will not include more than 5 eligible polyps (the first 5 that are detected) per patient in the study.
Laboratory Analysis:
Polyps and biopsies will be sent to the pathology lab of each center. The polyps will be evaluated according to common practice. In addition information regarding resection margins will be provided for each polyp: R0= free of adenomatous tissue, R1=adenomatous tissue detected in the margin. This information is not routinely provided by the pathologist as there is so far no data whether this information is reliable. Only adenomatous polyps will be included in the analysis. Hyperplastic polyps will not be included. Biopsies will only be processed after the diagnosis of an adenomatous polyp was made. Biopsies will be evaluated for presence of adenomatous tissue. The additional impact for the pathology lab includes a) processing of biopsies belonging to the polyp specimens, and b) providing information on polyp margins. The VA pathology lab estimated the financial impact to be low and there will be no financial requests. The pathological diagnosis, including the reading of the biopsies, will become part of the medical record. If biopsies contain adenomatous tissue the patient will be ask to return for a follow-up colonoscopy within 1 year. This is within current standard of care to repeat a colonoscopy to assure complete adenoma resection.
Status Flow
Change History
14 versions recorded-
Jan 2026 — Present [monthly]
Completed
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Sep 2024 — Present [monthly]
Completed
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Jul 2024 — Sep 2024 [monthly]
Completed
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Jan 2023 — Jul 2024 [monthly]
Completed
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Dec 2022 — Jan 2023 [monthly]
Completed
▶ Show 9 earlier versions
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Dec 2021 — Dec 2022 [monthly]
Completed
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Jan 2021 — Dec 2021 [monthly]
Completed
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Nov 2020 — Jan 2021 [monthly]
Completed
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Jun 2018 — Nov 2020 [monthly]
Completed
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May 2018 — Jun 2018 [monthly]
Completed
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Apr 2018 — May 2018 [monthly]
Completed
Phase: NA → None
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Sep 2017 — Apr 2018 [monthly]
Completed NA
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Aug 2017 — Sep 2017 [monthly]
Completed NA
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Jan 2017 — Aug 2017 [monthly]
Completed NA
First recorded
May 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Dartmouth-Hitchcock Medical Center
- White River Junction Veterans Affairs Medical Center
For direct contact, visit the study record on ClinicalTrials.gov .