A New Method for Colorectal Cancer Screening: Colon Capsule Endoscopy Compared to Conventional Endoscopy

NCT00991003 | Completed DMC

• 1 other identifier: EKBB25407
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Colon Capsule Endoscopy; Colorectal Cancer; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• The primary endpoint was the number of cancerous lesions and polyps detected on CCE compared to conventional colonoscopy

  7 Months

Secondary Outcomes (1)

• Secondary endpoints were completeness of the exam completeness, patient acceptance and adherence to preparation regimen

  7 Months

Study Arms (1)

Colon capsule endoscopy and colonoscopy

EXPERIMENTAL

Patients underwent CCE on day 1 and conventional colonoscopy on day 2

Procedure: Colon capsule endoscopy; Procedure: Conventional Colonoscopy

Interventions

Colon capsule endoscopy PROCEDURE

The PillCam® Colon Capsule is 11mm x 31mm in size (Figure 1), is equipped with two cameras acquiring pictures from both ends of the capsule at a rate of 4 frames per second (2 pictures per second and camera). The PillCam® Colon Capsule is automatically activated when it is removed from the package. It enters sleeping mode after approximately 10 minutes and starts transmitting again 1 h 45 min later. It has a total operating time of 8 - 10 hours. During the examination the patient wears a sensor array which is attached to the abdominal skin and a data recorder for storage of the information generated by the ingested capsule. After the examination the data are downloaded into the Given Imaging workstation and a video is generated.

Also known as: Pillcam Colon Capsule

Colon capsule endoscopy and colonoscopy

Conventional Colonoscopy PROCEDURE

Colon capsule endoscopy and colonoscopy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

• Pilz JB, Portmann S, Peter S, Beglinger C, Degen L. Colon Capsule Endoscopy compared to Conventional Colonoscopy under routine screening conditions. BMC Gastroenterol. 2010 Jun 18;10:66. doi: 10.1186/1471-230X-10-66.

  PMID: 20565828 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Julia B Pilz, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Christoph Beglinger, MD

  University Hospital, Basel, Switzerland

  STUDY DIRECTOR

• Lukas Degen, MD

  University Hospital, Basel, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 7, 2009
• Study Start: November 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: October 7, 2009

Record last verified: 2009-10

Locations

CH (1)