Colonoscopic Removal of Aberrant Crypt Foci: a Prospective, Randomized, Blinded Trial

National Naval Medical Center98 enrolled

Overview

We hypothesized that aberrant crypt foci (ACF) are precursors of colon cancer; their prevention would correlate with cancer risk and their elimination would reduce that risk. In this study we wished to (1) establish the feasibility of stain-enhanced magnification colonoscopy, (2) determine whether colorectal cancer is asociated with increased numbers of ACF, and (3) investigate the natural history of ACF and the durability of their elimination.

Subjects are randomly assigned at the time of stain-enhanced magnification colonoscopy to have any ACF removed or merely observed. Subjects are evenly divided into those with and those without a personal history of colon cancer. ACF are tabulated by an observer blinded to the subject's personal history. All subjects are then re-evaluated after one year by an observer blinded to the original procedure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Colorectal Neoplasms

Interventions

Surgical removal of ACFPROCEDURE

All ACF removed by either cold or hot colonoscopic biopsy forceps

Colonoscopic evaluation onlyPROCEDURE

Stain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Dept.of Defense Healthcare Beneficiaries 2. Age 18 or over, non-pregnant 3. History of colorectal cancer or other indication for colonoscopic screening 4. At least half of large intestine remaining 5. No use of investigational or chemotherapeutic drugs within 6 mos. - Exclusion Criteria: 1. History suggesting familial colon cancer syndrome 2. \< 6 mos since colon resection or since treatment for colon cancer 3. Anticipated colon surgery within one year of entry 4. Inability to participate in scheduled followup at one year 5. Medical or psychiatric condition which would make patient a poor candidate -

Locations (1)

National Naval Medical Center

Bethesda, Maryland, United States

Outcomes

Primary Outcomes

number, size, and location of ACF identified

Time frame: initially and after one year

Secondary Outcomes

complications of stain-enhanced, magnification colonoscopy

Time frame: initially and after one year

Data from ClinicalTrials.gov

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