Second-generation colon capsule endoscopy for detection of colorectal polyps: Systematic review and meta-analysis of clinical trials.
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SUBMITTER: Mollers T
PROVIDER: S-EPMC8041571 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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.
| S-EPMC4561761 | biostudies-literature
Project description:Capsule colonoscopy is an additional screening modality for colorectal cancer. Second-generation capsule colonoscopy (CC2) may have improved efficacy in the detection of colon adenomas as compared with prior devices. The purpose of this study was to evaluate the performance of CC2 in the detection of polyps in symptomatic and screening patients in the USA.Prospective, multicentre study.Two academic medical centres and two private practice facilities, evaluating patients with indications for colonoscopy.Patients underwent capsule colonoscopy procedure using magnesium citrate as a boost, followed by colonoscopy on the same day. The main outcome measurement was accuracy of CC2 for the detection of colorectal polyps ?6 and ?10?mm as compared with conventional colonoscopy.51 patients were enrolled, 50 of whom had CC2 and colonoscopy examinations and were included in the accuracy analysis. 30% and 14% of patients had polyps ?6 and ?10?mm, respectively. For lesions ?10?mm identified on conventional colonoscopy, CC2 sensitivity was 100% (95% CI 56.1% to 100%) with a specificity of 93.0% (79.9% to 98.2%). For polyps ?6?mm, the CC2 sensitivity was 93.3% (66.0% to 99.7%) and the specificity was 80.0% (62.5% to 90.9%). There was a 61% adequate cleansing rate with 64% of CC2 procedures being complete.In the initial US experience with CC2 there was adequate sensitivity for detecting patients with polyps ?6?mm in size. Magnesium citrate was inadequate as a boost agent.NCT01087528.
| S-EPMC4860721 | biostudies-literature
Project description:BackgroundColon capsule endoscopy (CCE) is a non-invasive alternative to colonoscopy. The reported sensitivity and specificity of CCE for the detection of clinically significant colonic neoplasia is high. To date, there have been no reported cases of colorectal cancer (CRC) missed by CCE which were located in segments adequately visualised by the capsule.Case presentationWe present the case of a 71-year-old female, who underwent CCE for new lower gastrointestinal symptoms. The CCE reported 17 polyps (largest size 10 mm) and angiodysplasia. A 40 mm caecal pole tumour, not detected by the CCE, was identified at follow up colonoscopy. Surgical resection was performed, and the pathology sample was reported as moderately differentiated adenocarcinoma, pT2 pN0 (0/19) M0, with no evidence of EMVI. The patient made an uneventful recovery. The caecal pole tumour was not definitively identified on retrospective review of the CCE images.ConclusionTo date, this is the first published case of a CRC missed entirely by CCE. Further research is required to allow calculation of the post CCE interval CRC rate to allow comparison with colonoscopy and CT colonogram.
| S-EPMC9123796 | biostudies-literature
Project description:The use of capsule endoscopy has become an approved method in small bowel diagnostics, but the same level of integration is not seen in large bowel diagnostics. We will use colon capsule endoscopy (CCE) as a filter test in colorectal cancer (CRC) screening between the faecal immunochemical test (FIT) and colonoscopy. We aim to investigate the clinical performance, population acceptability, and economic implications of the procedure in a large-scale clinical trial. We will randomly allocate 124 214 Danish citizens eligible for participation in the national CRC screening programme within the Region of Southern Denmark to either an intervention group or a control group. Prior to submitting a FIT, citizens randomised to the intervention group will be informed about their opportunity to undergo CCE, instead of colonoscopy, if the FIT is positive. Suspected cancers; >3 adenomas <10 mm in size, 1 adenoma >10 mm in size or >4 adenomas regardless of size, detected during CCE will generate an invitation to colonoscopy as per regular screening guidelines, whereas citizens with suspected low risk polyps will re-enter the biennial screening programme. Citizens with no CCE findings will be excluded from screening for 8 years. In the control group, citizens will follow standard screening procedures. All participants must consent prior to capsule ingestion. All collected data will be handled and stored in accordance with current data protection legislation. Approvals from the regional ethics committee (ref. S-20190100) and the Danish data protection agency have been obtained (ref. 19/29858). The study has been registered with ClinicalTrials.gov under: NCT04049357.
| S-EPMC7326244 | biostudies-literature
Project description:Background:Colon capsule endoscopy is a promising technique for evaluation of the colon, but its reproducibility is still unknown. Objective:This study assesses intra and inter-observer agreement in evaluations of colon capsule endoscopy videos. Methods:Forty-two complete colon capsule endoscopy investigations were analysed by three experts and two beginners. Intra-observer agreement was assessed in paired readings of two experts and two beginners. Agreement was determined by the intraclass correlation coefficient: poor (<0.5), moderate (0.5-0.75), good (0.75-0.9) and excellent (>0.9). Results:Agreement on 'indication for a following colonoscopy' based on the number and size of detected polyps and bowel cleansing quality was poor among all observers. Agreement among experts on the detection of large polyps and number of polyps was moderate, but agreement on bowel cleansing quality was poor. Beginners were in moderate agreement with the experts on polyp detection. Intra-observer agreement in experts was moderate to excellent for the detection of large polyps (?10?mm), excellent for the number of polyps, and poor to moderate for bowel cleansing quality. Intra-observer agreement in beginners was poor to moderate for all variables. Conclusions:This study shows a poor agreement on 'indication for a following colonoscopy', but a high intra and inter-observer agreement for polyp detection among experts, as well as a moderate agreement between beginners and experts.Trial registration: NCT02303756.
| S-EPMC6297930 | biostudies-literature
Project description:BackgroundAlthough there are papers reporting on the accuracy of colon capsule endoscopy (CCE) compared with colonoscopy (CS), there are few reports on the detection rates of significant lesions by endoscopy nurses. We previously reported no significant difference in the detection rates for small bowel capsule endoscopy (SBCE) images among two well-trained physicians and one expert nurse.ObjectiveTo evaluate the reading time and detection rate of the significant lesions of CCE images among novice and trained expert endoscopy nurses and novice physicians.MethodsCCE videos of 20 consecutive patients who performed both CCE and CS with clinically significant localized lesions were selected. Two trained expert endoscopy nurses, untrained two novice physicians, and novice three endoscopy nurses reviewed CCE videos. The detection rate of the lesions and reading time were compared among the three groups and were evaluated by comparison between the first and the second 10 videos.ResultsThe median reading time was the shortest (19 min) in the trained expert endoscopy nurses and the longest (45 min) in the novice nurses. The number of thumbnails tended to be more in the trained expert endoscopy nurses in the first 10-video reading. Although the detection rates of small polyps (<5 mm) were significantly lower (46.5%, p=0.025) in the novice nurses compared to the others, they were improved (35.2% to 63.5%, p=0.015) in the second 10 videos. The detection rates of tumor lesions by either one of two trained expert endoscopy nurses were higher compared to those by each novice physician.ConclusionsThe trained expert endoscopy nurses for CCE reading can reduce physician's time and improve the diagnostic yield.
| S-EPMC8100384 | biostudies-literature
Project description:Background and study aims Colon capsule endoscopy (CCE) is an alternative to conventional colonoscopy (CC) in specific clinical settings. High completion rates (CRs) and adequate cleanliness rates (ACRs) are fundamental quality parameters if CCE is to be widely implemented as a CC equivalent diagnostic modality. We conducted a systematic review and meta-analysis to investigate the efficacy of different bowel preparations regimens on CR and ACR in CCE. Patients and methods We performed a systematic literature search in PubMed, Embase, CINAHL, Web of Science, and the Cochrane Library. Data were independently extracted per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The primary outcome measures (CR, ACR) were retrieved from the individual studies and pooled event rates were calculated. Results Thirty-four observational (OBS) studies (n = 3,789) and 12 randomized clinical trials (RCTs) (n = 1,214) comprising a total 5,003 patients were included. The overall CR was 0.798 (95 % CI, 0.764-0.828); the highest CRs were observed with sodium phosphate (NaP) + gastrografin booster (n = 2, CR = 0.931, 95 % CI, 0.820-0.976). The overall ACR was 0.768 (95 % CI, 0.735-0.797); the highest ACRs were observed with polyethylene glycol (PEG) + magnesium citrate (n = 4, ER = 0.953, 95 % CI, 0.896-0.979). Conclusions In the largest meta-analysis on CCE bowel preparation regimens, we found that both CRs and ACRs are suboptimal compared to the minimum recommended standards for CC. PEG laxative and NaP booster were the most commonly used but were not associated with higher CRs or ACRs. Well-designed studies on CCE should be performed to find the optimal preparation regimen.
| S-EPMC8589531 | biostudies-literature
Project description:Background/aimsReliable and especially widely accepted preventive measures are crucial to further reduce the incidence of colorectal cancer (CRC). Colon capsule endoscopy (CCE) might increase the screening numbers among patients unable or unwilling to undergo conventional colonoscopy. This registry trial aimed to document and determine the CCE indications, findings, complications, and adverse events in outpatient practices and clinics throughout Germany.MethodsPatients undergoing CCE between 2010 and 2015 were enrolled in this prospective multicenter registry trial at six German centers. Patient demographics, outcomes, and complications were evaluated.ResultsA total of 161 patients were included. Of the CCE evaluations, 111 (68.9%) were considered successful. Pathological findings in the colon (n=92, 60.1%) and in the remaining gastrointestinal tract (n=38, 24.8%) were recorded. The main finding was the presence of polyps (n=52, 32.3%). Furthermore, five carcinomas (3.1%) were detected and histologically confirmed later. Adequate bowel cleanliness was more likely to be achieved in the outpatient setting (p<0.0001). Interestingly, 85 patients (55.6%) chose to undergo CCE based on personal motivation.ConclusionCCE seems to be a reliable and safe endoscopic tool for screening for CRC and detecting other diseases. Its patient acceptance and feasibility seems to be high, especially in the outpatient setting.
| S-EPMC7939783 | biostudies-literature
Project description:To assess the cleansing efficacy and safety of a new Colon capsule endoscopy (CCE) bowel preparation regimen.This was a multicenter, prospective, randomized, controlled study comparing two CCE regimens. Subjects were asymptomatic and average risk for colorectal cancer. The second generation CCE system (PillCam® COLON 2; Medtronic, Yoqneam, Israel) was utilized. Preparation regimens differed in the 1st and 2nd boosts with the Study regimen using oral sulfate solution (89 mL) with diatrizoate meglumine and diatrizoate sodium solution ("diatrizoate solution") (boost 1 = 60 mL, boost 2 = 30 mL) and the Control regimen oral sulfate solution (89 mL) alone. The primary outcome was overall and segmental colon cleansing. Secondary outcomes included safety, polyp detection, colonic transit, CCE completion and capsule excretion ? 12 h.Both regimens had similar cleansing efficacy for the whole colon (Adequate: Study = 75.9%, Control = 77.3%; P = 0.88) and individual segments. In the Study group, CCE completion was superior (Study = 90.9%, Control = 76.9%; P = 0.048) and colonic transit was more often < 40 min (Study = 21.8%, Control = 4%; P = 0.0073). More Study regimen subjects experienced adverse events (Study = 19.4%, Control = 3.4%; P = 0.0061), and this difference did not appear related to diatrizoate solution. Adverse events were primarily gastrointestinal in nature and no serious adverse events related either to the bowel preparation regimen or the capsule were observed. There was a trend toward higher polyp detection with the Study regimen, but this did not achieve statistical significance for any size category. Mean transit time through the entire gastrointestinal tract, from ingestion to excretion, was shorter with the Study regimen while mean colonic transit times were similar for both study groups.A CCE bowel preparation regimen using oral sulfate solution and diatrizoate solution as a boost agent is effective, safe, and achieved superior CCE completion.
| S-EPMC5752722 | biostudies-literature
Project description:BackgroundColonoscopy (CSPY) for colorectal cancer screening has several limitations. Colon Capsule Endoscopy (PillCam Colon, CCE) was compared to CSPY under routine screening conditions.MethodsWe performed a prospective, single-center pilot study at a University Hospital. Data were obtained from November 2007 until May 2008. Patients underwent CCE on Day 1 and CSPY on Day 2. Outcomes were evaluated regarding sensitivity and specificity of polyp detection rate, with a significance level set at >5 mm.Results59 individuals were included in this study, the results were evaluable in 56 patients (males 34, females 22; median age 59). CCE was complete in 36 subjects. Polyp detection rate for significant polyps was 11% on CSPY and 27% on CCE.6/56 (11%) patients had polyps on CSPY not detected on CCE (miss rate).Overall sensitivity was 79% (95% confidence interval [CI], 61 to 90), specificity was 54% (95% CI, 35 to 70), positive predictive value (PPV) was 63% and negative predictive value (NPV) was 71%. Adjusted to significance of findings, sensitivity was 50% (95% CI, 19 to 81), specificity was 76% (95% CI, 63 to 86), PPV was 20% and NPV was 93%.ConclusionIn comparison to the gold standard, the sensitivity of CCE for detection of relevant polyps is low, however, the high NPV supports its role as a possible screening tool.Trial registrationNCT00991003.
| S-EPMC2905323 | biostudies-literature