Complete Histologic Resection of Adenomatous Polyps?

NCT01224444 | Completed Results DMC

• 1 other identifier: DMS-21237
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 2

Brief Summary

Colorectal cancer is the second most common cause of cancer death in the US. Colonoscopy is considered the best test colorectal cancer screening. It allows resection of adenomatous polyps (a known cancer precursor) and thus, interrupt the adenoma-carcinoma sequence. Despite the potential benefit of screening colonoscopy recent studies have reported cases of colorectal cancers in a short interval after prior screening or surveillance colonoscopies. One possible cause of such interval cancers may be incomplete resection of adenomatous polyps and hence ongoing growth and cancer development in such lesions. Complete resection may be particularly important for polyps of at least 5mm in size as up 10% of such polyps higher risk lesions as villous adenoma, tubulovillous adenoma, high grade dysplasia, or early carcinoma. Although adenoma resection of sessile and flat adenomatous polyps between 5 and 20mm is believed to be well standardized data on complete resection of adenomatous tissue are sparse. This may be related to the assumption that using a snare with electro-cautery will successfully remove the polyp and cauterize remaining marginal adenomatous tissue and hence completely remove and or destroy the lesion. The investigators are interested in examining how often sessile adenomatous polyps between 5 and 20mm are completely removed using standard polypectomy snare. The investigation was also directed at a comparison between complete resection of polyps between 5 and 9mm and 10 and 20mm.

Conditions

Adenomatous Polyps

Keywords

colon polyps; adenoma resection; colon cancer screening; colonoscopy

Outcome Measures

Primary Outcomes (1)

• Percent of Incompletely Resected Adenomatous Polyps

  Proportion of incompletely resected adenomatous polyps (5 to 20mm), defined by remaining adenomatous tissue in marginal biopsies after snare resection.

  1 year

Secondary Outcomes (1)

• Incomplete Adenoma Resection of Small and Large Adenomas

  1 year

Study Arms (1)

All adenomatous polyps

Standard polypectomy snare of adenomatous polyps (included serrated adenomas) from ≤5mm to ≤20mm.

Other: standard polypectomy snare

Interventions

standard polypectomy snare OTHER

Electrocautery snare resection of sessile colonic polyps

All adenomatous polyps

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants eligible for recruitment are patients who present for a colonoscopy to the VAMC or DHMC Gastroenterology department conducting this study. Upon arrival for a scheduled colonoscopy patient records will be reviewed to determine eligibility.

You may not qualify if:

• All patients who are found to have colonic polyp between 5 and 20mm in size will be included in the study
• Pedunculated polyps (estimated stalk diameter \< 50% polyp head diameter, stalk at least 5 mm)
• Any suspicion of perforation or deeper defects after polypectomy, irrespective whether treated or not.
• Post-polypectomy bleeding requiring hemostasis.
• Patients with known inflammatory bowel disease or active colitis
• Patients who are receiving an emergency colonoscopy
• Poor general health (ASA class\>3)
• Patients on coumadin or with coagulopathy with an elevated INR ≥1.8, or platelets \<50.
• Poor bowel preparation
• Patients who do not consent
• Pregnancy

Sponsors & Collaborators

• White River Junction Veterans Affairs Medical Center: lead
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (2)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

White River Junction VAMC

White River Junction, Vermont, 05009, United States

Location

Related Publications (1)

• 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.

  PMID: 23022496 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Adenomatous Polyps; Colonic Polyps

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Heiko Pohl
• Organization: White River Junction VA

heiko.pohl@dartmouth.edu

802-295-9363

Study Officials

• Heiko Pohl, MD

  White River Junction VAMC, Dartmouth Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 20, 2010
• Study Start: May 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2013
• Last Updated: January 12, 2015
• Results First Posted: January 12, 2015

Record last verified: 2014-12

Locations

US (2)