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Comparative Study of Colon Capsule and Virtual Colonoscopy (VICOCA)

ABSTRACT: Summary Colorectal cancer (CRC) represents the second leading cause of cancer deaths in Spain (11,000 deaths per year). Screening of the population over 50 years of age with no significant history (intermediate risk) is recommended, but which screening method is best for promoting adherence in this type of patient has not been well established. There are currently two screening methods that are less invasive than conventional colonoscopy and seem to have higher sensitivity than the test for faecal occult blood (FOBT). These two methods are the colon capsule, which consists in ingesting a capsule that takes photographs of the colon, and virtual colonoscopy, which is a radiological technique. Objectives: 1. To demonstrate that virtual colonoscopy and colon capsule are effective CRC screening techniques in the intermediate risk population, with diagnostic rates comparable to conventional colonoscopy (concordance). 2. To compare the diagnostic rates of the colon capsule and virtual colonoscopy with respect to the size and characteristics of the lesions visualised. 3. To compare the participation rates for each screening strategy and identify the factors that influence participation (individual, family, and socioeconomic factors as well as those relating to the doctor).

DISEASE(S): Colonic Polyps,Adenoma

PROVIDER: 2162262 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description: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.

Project description:Colorectal cancer (CRC) is the second most common cause of cancer-related death in the Western world, with 500000 deaths per year worldwide. Colonoscopy is accepted as a primary CRC screening tool in many countries. As a preventative procedure, its main purpose is to enable the early diagnosis of CRC at a curable stage and to identify and remove pre-malignant adenomas. Cecal intubation is associated with an increased detection rate of advanced neoplasia, as 33-50% of advanced neoplasia is located in the proximal colon. Complete colonic evaluation is therefore a well-recognized measure of colonoscopy quality control. Cecal intubation rates of ≥ 90% of all colonoscopies in routine clinical practice and ≥ 95% in screening colonoscopies are recommended. Unfortunately, the cecal intubation rate in daily clinical practice is often lower than the target of ≥ 90%, with reported percentages varying from 76.9% to 98.4%. This means that after an incomplete colonoscopy, malignant and pre-malignant lesions may be missed if further investigation is not pursued. Several explanatory factors for incomplete colonoscopy have been described. After an incomplete conventional colonoscopy, patients are required to undergo another test to complete the visualization of the colon. Options for incomplete examinations because of anatomic reasons include both radiologic and endoscopic means. CT Colonography (CTC ) permits to visualise the whole colon, is minimally invasive, does not require sedation and is well accepted by the patient. The PillCam Colon Capsule Endoscopy (Given Diagnostic System)offers an alternative approach for endoscopic visualization of the colon in patients with an incomplete conventional colonoscopy. Advantages of the PillCam Colon Capsule Endoscopy (PCCE) include the elimination of the need for sedation, the minimally invasive, painless nature of the exam, no need of X-rays and the ability to pursue normal daily activities immediately following the procedure. This is a study that is designed to evaluate the performance of the PCCE in the evaluation of patients with an incomplete colonoscopy, compared to the CT-colonography. PCCE and CT-colonography procedures will be compared in regards to completeness of the procedure and detection of lesions in the colon that would have been missed by the incomplete conventional colonoscopy.

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Comparative Study of Colon Capsule and Virtual Colonoscopy (VICOCA)

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