A New Method for Colorectal Cancer Screening: Colon Capsule Endoscopy Compared to Conventional Endoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 59
- Locations
- 2
- Primary Endpoint
- The primary endpoint was the number of cancerous lesions and polyps detected on CCE compared to conventional colonoscopy
Study Overview
Brief Summary
Introduction:
Prevention of colorectal cancer (CRC) is feasible through polypectomy on screening colonoscopy. Patient acceptance remains the main limiting factor for execution. Colon capsule endoscopy (CCE) might be a novel method for large populations.
Aims and methods:
Patients referred for screening means or lower gastrointestinal complaints were included in this single center pilot study. They underwent preparation and then ingested the capsule (PillCam Colon). Standard colonoscopy was performed the next morning. Significance was defined as polyps >5mm in size. Performance of exams was by independent physician with blinding of results.
Detailed Description
Study design This was a prospective, single center pilot analysis under screening conditions. Patient enrollment was from November 5, 2007, to May 7, 2008. All patients provided written informed consent. Patients underwent CCE on day 1 and conventional colonoscopy on day 2, the examinations were done by different physicians. Results were blinded until both examinations had been completed and until interobserver evaluation was finished. Patient acceptance was assessed with a questionnaire after completion of both examinations.
This study was approved by the ethics committee. The study was partly funded by the Nycomed Fund of the University Hospital Basel, Switzerland and by Given Imaging Ltd., Yoqneam, Israel).
The authors designed the study, gathered and analyzed the data; the sponsors had no role in design or conduct of the study nor did they review or approve the data.
Patients Men and women above the age of 50 years without symptoms (Indication for screening) or with lower gastrointestinal signs and symptoms and individuals younger than 50 years, minimum 18 years, without symptoms but with a positive family history for colorectal cancer (CRC) (Indication for screening) were considered for this study. Exclusion criteria were CRC in the patient's history, cardiac pacemaker, contraindications for sodium phosphate solution (Colophos®) and risk factors for capsule retention including surgical intestinal anastomosis, Crohn's disease, diverticulitis and radiologically suspected bowel obstruction.
Data collection General characteristic of the patients were assembled, including demographics, family history and recent surgery, as well as bowel habits.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •male/female above the age of 50 years with symptoms (Indication for screening)
- •male/female above the age of 50 years without symptoms
- •male/female younger than 50 years without symptoms but with a positive family history for colorectal cancer (CRC) (Indication for screening)
Exclusion Criteria
- •CRC in the patient's history
- •cardiac pacemaker
- •contraindications for sodium phosphate solution (Colophos®)
- •risk factors for capsule retention including surgical intestinal anastomosis, Crohn's disease, diverticulitis and radiologically suspected bowel obstruction
Outcomes
Primary Outcomes
The primary endpoint was the number of cancerous lesions and polyps detected on CCE compared to conventional colonoscopy
Time Frame: 7 Months
Secondary Outcomes
- Secondary endpoints were completeness of the exam completeness, patient acceptance and adherence to preparation regimen(7 Months)