Colon Capsule Versus Virtual Colonoscopy for Colorectal Cancer Screening

NCT02558881 | Completed

• 1 other identifier: 2012-757
• Study Type: observational
• Target: 664
• Locations: 1 country
• Sites: 1

Brief Summary

France is among the countries with a high incidence of colorectal cancer. The prognosis associated with colorectal cancer is related to the development stage of the disease at diagnosis. Thus, when the cancer is detected and treated at an early stage, the survival rate at 5 years was 90%. It is therefore a major issue of screening is widespread in France since the end of 2008. This screening is based on a two step strategy: 1) the occult blood in the stool (FOBT) and if positive 2) the realization of an optical colonoscopy examination currently regarded as the evaluation procedure colon reference. But as part of this organized screening, 13% of those with a positive FOBT ultimately refuse to have an optical colonoscopy. Under the refusal, virtual colonoscopy may be proposed as an alternative according to the recommendations of the National Health Authority in 2010. But it has never been assessed as part of organized screening. Similarly another alternative is recently developed colic capsule that benefits of development in recent years of the capsule for the small intestine which has become the gold standard for diagnosis of most diseases of the small intestine (bleeding occult, diagnosis of unknown colitis...). Therefore the study proposes virtual colonoscopy or colon capsule for people with a positive FOBT as part of organized screening and did not realize optical colonoscopy after the usual procedure and complete recovery. This study aims to answer the question of the place of colic capsule as part of organized screening. An economic component is integrated to assess, in terms of health insurance, the cost associated with these two exams, and compare them to the cost of optical colonoscopy. The proposed study is an observational study of impact of an alternative screening strategy for colorectal cancer whose primary objective is to compare the rate of acceptance of virtual colonoscopy and colon capsule in patients refusing optical colonoscopy.

Conditions

Colorectal Cancer

Keywords

screening; colorectal cancer; colon capsule; virtual colonoscopy

Outcome Measures

Primary Outcomes (1)

• Acceptance rate of colonic capsule versus virtual colonoscopy.

  Acceptance is defined by the fact that a person having made an appointment for one of the two exams and he went to the review

  A period of three months after sending the letter of invitation to an alternative to optical colonoscopy is left to the person.

Secondary Outcomes (9)

• Success rate of virtual colonoscopy and colon capsule: full review rate of colonic mucosa.

  6 months

• Failure rate of examinations by cause

  6 months

• Diagnostic performance of virtual colonoscopy and colon capsule

  6 months

• Achievement rate of optical colonoscopy if a lesion is found, either by virtual colonoscopy, or by colonic capsule

  6 months

• Sensitivity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps

  6 months

Study Arms (2)

Virtual colonoscopy

With virtual colonoscopy, the patient does not need to be hospitalized for examination, which is usually done without hospitalization. A bowel preparation is necessary. It may vary from site to site, but it generally comprises polyethylene glycol or sodium phosphate. The residual stools are "marked" by ingestion of a radiopaque product to differentiate colic lesions. But no contrast agent is injected intravenously. The patient should be supine and a rectal probe is set up to inject either air or CO2. The vesting period does not exceed thirty seconds apnea, and overall completion time of the examination (patient table) is about 10 minutes.

Procedure: Virtual colonoscopy

Colon capsule

The colon capsule comprises two cameras located at both ends. Image acquisition is set between four to thirty-five images per second. It begins immediately after ingestion of the capsule which allows recording of esophageal and gastric images. She paused for 2 hours (to save batteries) while crossing the small intestine. It is reactivated in the terminal ileum. The films analysis time is approximately 1 hour, and the capsule remains on average 3 hours in the colon.

Procedure: Colon capsule

Interventions

Virtual colonoscopy PROCEDURE

Virtual colonoscopy

Colon capsule PROCEDURE

Colon capsule

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a positive FOBT at screening organized colorectal cancer, patients who have not achieved optical colonoscopy and who received the usual procedure and complete recovery.

You may qualify if:

• Patients with a positive FOBT at screening organized colorectal cancer, patients who have not achieved optical colonoscopy and who received the usual procedure and complete recovery

You may not qualify if:

• None

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopsices Civils de Lyon

Lyon, France

Location

Related Publications (1)

• Pioche M, Ganne C, Gincul R, De Leusse A, Marsot J, Balique J, Fond A, Bretagnolle M, Henry L, Billaud Y, Malezieux R, Lapalus MG, Chambon-Augoyard C, Del Tedesco E, Scalone O, Montoy JC, Russias B, Detry A, Veniat F, Qiu J, Valette PJ, Taillandier A, Saurin JC, Tomczyk-Ferrero J, Gandilhon C, Vecchiato L, Soler-Michel P, Ponchon T. Colon capsule versus computed tomography colonography for colorectal cancer screening in patients with positive fecal occult blood test who refuse colonoscopy: a randomized trial. Endoscopy. 2018 Aug;50(8):761-769. doi: 10.1055/s-0044-100721. Epub 2018 Feb 27.

  PMID: 29486502 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Thierry PONCHON, Professor

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 24, 2015
• Study Start: June 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

FR (1)