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Colon capsule endoscopy versus CT colonography in FIT-positive colorectal cancer screening subjects: a prospective randomised trial-the VICOCA study.

ABSTRACT: BACKGROUND:Colon capsule endoscopy (CCE) and CT colonography (CTC) are minimally invasive techniques for colorectal cancer (CRC) screening. Our objective is to compare CCE and CTC for the identification of patients with colorectal neoplasia among participants in a CRC screening programme with positive faecal immunochemical test (FIT). Primary outcome was to compare the performance of CCE and CTC in detecting patients with neoplastic lesions. METHODS:The VICOCA study is a prospective, single-centre, randomised trial conducted from March 2014 to May 2016; 662 individuals were invited and 349 were randomised to CCE or CTC before colonoscopy. Endoscopists were blinded to the results of CCE and CTC. RESULTS:Three hundred forty-nine individuals were included: 173 in the CCE group and 176 in the CTC group. Two hundred ninety individuals agreed to participate: 147 in the CCE group and 143 in the CTC group. In the intention-to-screen analysis, sensitivity, specificity and positive and negative predictive values for the identification of individuals with colorectal neoplasia were 98.1%, 76.6%, 93.7% and 92.0% in the CCE group and 64.9%, 95.7%, 96.8% and 57.7% in the CTC group. In terms of detecting significant neoplastic lesions, the sensitivity of CCE and CTC was 96.1% and 79.3%, respectively. Detection rate for advanced colorectal neoplasm was higher in the CCE group than in the CTC group (100% and 93.1%, respectively; RR?=?1.07; p?=?0.08). Both CCE and CTC identified all patients with cancer. CCE detected more patients with any lesion than CTC (98.6% and 81.0%, respectively; RR?=?1.22; p?=?0.002). CONCLUSION:Although both techniques seem to be similar in detecting patients with advanced colorectal neoplasms, CCE is more sensitive for the detection of any neoplastic lesion. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02081742 . Registered: September 16, 2013.

SUBMITTER: Gonzalez-Suarez B

PROVIDER: S-EPMC7500543 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Colon capsule endoscopy versus CT colonography in FIT-positive colorectal cancer screening subjects: a prospective randomised trial-the VICOCA study.

González-Suárez Begoña B Pagés Mario M Araujo Isis Karina IK Romero Cristina C Rodríguez de Miguel Cristina C Ayuso Juan Ramón JR Pozo Àngels À Vila-Casadesús Maria M Serradesanferm Anna A Ginès Àngels À Fernández-Esparrach Glòria G Pellisé Maria M López-Cerón María M Flores David D Córdova Henry H Sendino Oriol O Grau Jaume J Llach Josep J Serra-Burriel Miquel M Cárdenas Andrés A Balaguer Francesc F Castells Antoni A

BMC medicine 20200918 1

<h4>Background</h4>Colon capsule endoscopy (CCE) and CT colonography (CTC) are minimally invasive techniques for colorectal cancer (CRC) screening. Our objective is to compare CCE and CTC for the identification of patients with colorectal neoplasia among participants in a CRC screening programme with positive faecal immunochemical test (FIT). Primary outcome was to compare the performance of CCE and CTC in detecting patients with neoplastic lesions.<h4>Methods</h4>The VICOCA study is a prospecti ...[more]

PMID: 32943059

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Project description:BackgroundColorectal cancer is a leading cause of mortality and morbidity in Ontario. Most cases of colorectal cancer are preventable through early diagnosis and the removal of precancerous polyps. Colon capsule endoscopy is a non-invasive test for detecting colorectal polyps.ObjectivesThe objectives of this analysis were to evaluate the cost-effectiveness and the impact on the Ontario health budget of implementing colon capsule endoscopy for detecting advanced colorectal polyps among adult patients who have been referred for computed tomographic (CT) colonography.MethodsWe performed an original cost-effectiveness analysis to assess the additional cost of CT colonography and colon capsule endoscopy resulting from misdiagnoses. We generated diagnostic accuracy data from a clinical evidence-based analysis (reported separately), and we developed a deterministic Markov model to estimate the additional long-term costs and life-years lost due to false-negative results. We then also performed a budget impact analysis using data from Ontario administrative sources. One-year costs were estimated for CT colonography and colon capsule endoscopy (replacing all CT colonography procedures, and replacing only those CT colonography procedures in patients with an incomplete colonoscopy within the previous year). We conducted this analysis from the payer perspective.ResultsUsing the point estimates of diagnostic accuracy from the head-to-head study between colon capsule endoscopy and CT colonography, we found the additional cost of false-positive results for colon capsule endoscopy to be $0.41 per patient, while additional false-negatives for the CT colonography arm generated an added cost of $116 per patient, with 0.0096 life-years lost per patient due to cancer. This results in an additional cost of $26,750 per life-year gained for colon capsule endoscopy compared with CT colonography. The total 1-year cost to replace all CT colonography procedures with colon capsule endoscopy in Ontario is about $2.72 million; replacing only those CT colonography procedures in patients with an incomplete colonoscopy in the previous year would cost about $740,600 in the first year.LimitationsThe difference in accuracy between colon capsule endoscopy and CT colonography was not statistically significant for the detection of advanced adenomas (≥ 10 mm in diameter), according to the head-to-head clinical study from which the diagnostic accuracy was taken. This leads to uncertainty in the economic analysis, with results highly sensitive to changes in diagnostic accuracy.ConclusionsThe cost-effectiveness of colon capsule endoscopy for use in patients referred for CT colonography is $26,750 per life-year, assuming an increased sensitivity of colon capsule endoscopy. Replacement of CT colonography with colon capsule endoscopy is associated with moderate costs to the health care system.

Project description:PurposeCT colonography enables three-dimensional measurement of colon length. However, previous studies using CT colonography have not examined the association with gender, age, physique, a history of laparotomy and bowel habits, all possible contributory factors to colon length. The aim of this study is to investigate factors associated with colon length.Materials and methodsWe conducted a post hoc analysis based on data obtained from a previous multi-center trial including 321 patients with positive fecal immunochemical tests who underwent CT colonography. Colon length was measured using a computer-generated center line and was divided at the iliac crest level into the distal and proximal colons. Bowel habits were classified into three groups: A-daily; B-once every 2 or 3 days; and C-less than once in 3 days. Statistical comparison was made using one-way ANOVA with Bonferroni's correction.ResultsA total of 295 patients were analyzed. The entire colon length (cm, mean ± standard deviation) of individual patients was 150.3 ± 18.5 cm and ranged from 109.7 to 195.9 cm. The female colon was significantly longer than the male colon (154.3 ± 18.1 cm vs. 147.1 ± 18.3 cm; p = 0.022). Colon length showed trends associated with age (p = 0.18) and a history of laparotomy (p = 0.14). According to bowel habits, the entire colon measured 147.4 ± 17.9 in group A, 154.7 ± 18.5 in group B and 158.6 ± 18.3 in group C, and significant differences were observed for "A vs. C" (p = 0.002) and "A vs. B" (p = 0.014). In subgroup analysis by colon segment, the proximal colon trended similarly to the entire colon while there were no trends for the distal colon.ConclusionsThis study has clearly demonstrated that bowel habits and gender both correlate with the length of the entire colon measured by CT colonography, and in particular, the proximal colon. Using CT colonography, we measured the colon length in 295 patients. The entire colon length was 150.3 ± 18.5 cm on average. Females and constipated (less frequent defecation) patients have a significantly longer colon, and in particular, the proximal colon. Colon length showed trends associated with age and a history of laparotomy.

Dataset Information

Colon capsule endoscopy versus CT colonography in FIT-positive colorectal cancer screening subjects: a prospective randomised trial-the VICOCA study.

Publications

Colon capsule endoscopy versus CT colonography in FIT-positive colorectal cancer screening subjects: a prospective randomised trial-the VICOCA study.

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