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Complete Histologic Resection of Adenomatous Polyps?

Complete Histologic Resection of Adenomatous Polyps? (Complete Adenoma REsection Trial - CARE Trial)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01224444
Acronym
CARE
Enrollment
269
Registered
2010-10-20
Start date
2008-05-31
Completion date
2013-01-31
Last updated
2015-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomatous Polyps

Keywords

colon polyps, adenoma resection, colon cancer screening, colonoscopy

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.

Detailed description

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.

Interventions

OTHERstandard polypectomy snare

Electrocautery snare resection of sessile colonic polyps

Sponsors

Dartmouth-Hitchcock Medical Center
CollaboratorOTHER
White River Junction Veterans Affairs Medical Center
Lead SponsorFED

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Any patient ≥40 and \<85 who presents for a colonoscopy and does not meet any of the

Exclusion criteria

mentioned below will be asked to participate * All patients who are found to have colonic polyp between 5 and 20mm in size will be included in the study

Design outcomes

Primary

MeasureTime frameDescription
Percent of Incompletely Resected Adenomatous Polyps1 yearProportion of incompletely resected adenomatous polyps (5 to 20mm), defined by remaining adenomatous tissue in marginal biopsies after snare resection.

Secondary

MeasureTime frameDescription
Incomplete Adenoma Resection of Small and Large Adenomas1 yearComparison of the proportion of incompletely resected adenomatous polyps by size (5-9mm versus 10-20mm).

Countries

United States

Participant flow

Pre-assignment details

1429 patients were consented, of which 269 met inclusion criteria.

Participants by arm

ArmCount
All Adenomatous Polyps
Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
269
Total269

Baseline characteristics

CharacteristicAll Adenomatous Polyps
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
102 Participants
Age, Categorical
Between 18 and 65 years
167 Participants
Age, Continuous63.4 years
STANDARD_DEVIATION 9.1
Region of Enrollment
United States
269 participants
Sex: Female, Male
Female
43 Participants
Sex: Female, Male
Male
226 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 269
serious
Total, serious adverse events
0 / 269

Outcome results

Primary

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.

Time frame: 1 year

ArmMeasureValue (NUMBER)
All Adenomatous PolypsPercent of Incompletely Resected Adenomatous Polyps10.1 percentage of incomplete resection
Secondary

Incomplete Adenoma Resection of Small and Large Adenomas

Comparison of the proportion of incompletely resected adenomatous polyps by size (5-9mm versus 10-20mm).

Time frame: 1 year

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026