Colon Capsule Versus Virtual Colonoscopy for Colorectal Cancer Screening

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Virtual colonoscopy
* Procedure: Colon capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Virtual colonoscopy<br>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<br> <br> |
| Colon capsule<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of virtual colonoscopy and colon capsule: full review rate of colonic mucosa. |  | 6 months | 
| Failure rate of examinations by cause | 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 ...) | 6 months | 
| Diagnostic performance of virtual colonoscopy and colon capsule | Percentage of patients with suspected colorectal neoplastic lesions | 6 months | 
| Achievement rate of optical colonoscopy if a lesion is found, either by virtual colonoscopy, or by colonic capsule | Percentage of patients who achieve an optical colonoscopy after suspected neoplastic colorectal lesion | 6 months | 
| Sensitivity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps | Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter | 6 months | 
| Specificity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps | Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter | 6 months | 
| Positive and negative predictive values of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps | Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter | 6 months | 
| Percentage of cancers diagnosed through virtual colonoscopy or colonic capsule |  | 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 | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening, colorectal cancer, colon capsule, virtual colonoscopy