Colon Capsule Versus Virtual Colonoscopy for Colorectal Cancer Screening (COCAGI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02558881|
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : September 24, 2015
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.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Procedure: Virtual colonoscopy Procedure: Colon capsule|
|Study Type :||Observational|
|Actual Enrollment :||664 participants|
|Observational Model:||Case Control|
|Official Title:||Evaluation of a Complementary Action of Recruitment of Patients With a Positive Screening Test and Not Realizing Optical Colonoscopy as Part of Organized Colorectal Cancer Screening|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||March 2015|
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
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
- Acceptance rate of colonic capsule versus virtual colonoscopy. [ Time Frame: A period of three months after sending the letter of invitation to an alternative to optical colonoscopy is left to the person. ]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
- Success rate of virtual colonoscopy and colon capsule: full review rate of colonic mucosa. [ Time Frame: 6 months ]
- Failure rate of examinations by cause [ Time Frame: 6 months ]Percentage of bad colic preparations, percentage against-indications, complication rate, percentage capsules have not been to the end of the colon, percentage of other causes (eg. technical ...)
- Diagnostic performance of virtual colonoscopy and colon capsule [ Time Frame: 6 months ]Percentage of patients with suspected colorectal neoplastic lesions
- Achievement rate of optical colonoscopy if a lesion is found, either by virtual colonoscopy, or by colonic capsule [ Time Frame: 6 months ]Percentage of patients who achieve an optical colonoscopy after suspected neoplastic colorectal lesion
- Sensitivity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps [ Time Frame: 6 months ]Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter
- Specificity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps [ Time Frame: 6 months ]Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter
- Positive and negative predictive values of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps [ Time Frame: 6 months ]Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter
- Percentage of cancers diagnosed through virtual colonoscopy or colonic capsule [ Time Frame: 6 months ]
- Additional costs generated by the implementation of a complementary action of screening for patients with a positive FOBT and did not realize optical colonoscopy [ Time Frame: 6 months ]The costs taken into account will be the direct medical costs of two exams, as well as non-medical direct costs: 1) Letters of invitation to perform any of the tests, 2) Examination conducted (colon capsule or virtual colonoscopy), 3) Letters of Transmittal results
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558881
|Hopsices Civils de Lyon|
|Principal Investigator:||Thierry PONCHON, Professor||Hospices Civils de Lyon|