Colon capsule endoscopy investigation based on faecal haemoglobin concentration in symptomatic patients to detect bowel disease.
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SUBMITTER: MacLeod C
PROVIDER: S-EPMC10869214 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Colon capsule endoscopy investigation based on faecal haemoglobin concentration in symptomatic patients to detect bowel disease.
MacLeod Campbell C Mowat Craig C Hudson Jemma J Strachan Judith J Watson Angus James Mackintosh AJM
BJS open 20240101 1
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Project description:AimTo assess the cleansing efficacy and safety of a new Colon capsule endoscopy (CCE) bowel preparation regimen.MethodsThis 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.ResultsBoth 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.ConclusionA 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:BackgroundMeasurement of faecal haemoglobin using faecal immunochemistry testing is recommended in patients presenting with symptoms suspicious for colorectal cancer, to aid in triage and prioritization of definitive investigations. While its role in colorectal cancer has been extensively investigated, the ability of faecal immunochemistry testing to detect adenomas in symptomatic patients is unclear.MethodsA multicentre prospective observational study was conducted between April 2017 and March 2019, recruiting adults from 24 hospitals across England and 59 general practices in London who had been urgently referred with suspected colorectal cancer symptoms. Each patient provided a stool sample for faecal immunochemistry testing, in parallel with definitive investigation. A final diagnosis for each patient was recorded, including the presence, size, histology, and risk type of colonic polyps. The outcome of interest was the sensitivity of faecal immunochemistry testing in detecting the presence of adenomas.ResultsOf 3496 patients included in the analysis, 553 (15.8 per cent) had polyps diagnosed. Sensitivity of faecal immunochemistry testing for polyp detection was low across all ranges; with a cut-off for faecal haemoglobin of 4 µg/g or lower, sensitivity was 34.9 per cent and 46.8 per cent for all polyp types and high-risk polyps respectively. The area under the receiver operating characteristic curve in detection probability was relatively low for both intermediate-risk (0.63) and high-risk polyps (0.63).ConclusionWhile faecal immunochemistry testing may be useful in prioritizing investigations to diagnose colorectal cancer, if used as a sole test, the majority of polyps would be missed and the opportunity to prevent progression to colorectal cancer may be lost.
| S-EPMC9994599 | biostudies-literature
Project description:BackgroundThe diagnostic accuracy of colon capsule endoscopy (CCE) depends on a well-cleansed bowel. Evaluating the cleansing quality can be difficult with a substantial interobserver variation.ObjectivesOur primary aim was to establish a standard of agreement for bowel cleansing in CCE based on evaluations by expert readers. Then, we aimed to investigate the interobserver agreement on bowel cleansing.DesignWe conducted an interobserver agreement study on bowel cleansing quality.MethodsReaders with different experience levels in CCE and colonoscopy evaluated bowel cleansing quality on the Leighton-Rex scale and Colon Capsule CLEansing Assessment and Report (CC-CLEAR), respectively. All evaluations were reported on an image level. A total of 24 readers rated 500 images on each scale.ResultsAn expert opinion-based agreement standard could be set for poor and excellent cleansing but not for the spectrum in between, as the experts agreed on only a limited number of images representing fair and good cleansing. The overall interobserver agreement on the Leighton-Rex full scale was good (intraclass correlation coefficient (ICC) 0.84, 95% CI (0.82-0.85)) and remained good when stratified by experience level. On the full CC-CLEAR scale, the overall agreement was moderate (ICC 0.62, 95% CI (0.59-0.65)) and remained so when stratified by experience level.ConclusionThe interobserver agreement was good for the Leighton-Rex scale and moderate for CC-CLEAR, irrespective of the reader's experience level. It was not possible to establish an expert-opinion standard of agreement for cleansing quality in CCE images. Dedicated training in using the scales may improve agreement and enable future algorithm calibration for artificial intelligence supported cleansing evaluation.Trial registrationAll included images were derived from the CAREforCOLON 2015 trial (Registered with The Regional Health Research Ethics Committee (Registration number: S-20190100), the Danish data protection agency (Ref. 19/29858), and ClinicalTrials.gov (registration number: NCT04049357)).
| S-EPMC11500223 | biostudies-literature
Project description:Background and study aimsColon capsule endoscopy (CCE) is becoming increasingly popular in Europe. However, development of quality assurance and standardized terminology has not kept pace with clinical integration of this technology. As a result, there are significant variations in reporting standards, highlighting the need for a standardized terminology and framework. We used the RAND process to achieve a consensus of experts to determine the terminology in CCE, bowel cleansing assessment, and quality assurance reporting and future research priorities.MethodsA panel comprising 14 European CCE experts evaluated 45 statements during the international REFLECT symposium (Nyborg, Denmark) through three survey rounds and face-to-face and virtual discussions in the initial two rounds. Participants anonymously rated statement appropriateness.ResultsTwenty-eight consensus statements were developed. Eight statements focus on consistent terminology for confirming CCE-detected polypoid and inflammatory colonic lesions with colonoscopy. To ensure standardization and quality assurance, 13 mandatory fields were recommended for inclusion in a CCE report. Three endorsed reporting methodologies were suggested, emphasizing prompt notification for suspected malignant findings, recommending a generic disclaimer regarding stomach and small bowel visualization intentions, and establishing reporting timelines at an interdepartmental level based on urgency. Four bowel preparation scale-related statements led to the recommendation to adoptithe Colon Capsule CLEansing Assessment and Reporting (CC-CLEAR) scale as the preferred scale.ConclusionsThis study established a framework for terminology, reporting, and assessment of bowel cleansing for CCE. Future research should focus on optimizing bowel preparation regimens and exploring artificial intelligence applications in CCE.
| S-EPMC11827750 | 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:Capsule endoscopy (CE) enables evaluation of the entire mucosal surface of the small bowel (SB), which is one of the most important steps for evaluating obscure gastrointestinal bleeding. Although the diagnostic yield of SB CE depends on many clinical factors, there are no reports on quality indicators. Thus, the Korean Gut Image Study Group (KGISG) publishes an article titled, "Quality Indicators for Small Bowel Capsule Endoscopy" under approval from the Korean Society of Gastrointestinal Endoscopy (KSGE). Herein, we initially identified process quality indicators, while the structural and outcome indicators are reserved until sufficient clinical data are accumulated. We believe that outcomes of SB CE can be improved by trying to meet our proposed quality indicators.
| S-EPMC5398361 | 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) has the potential to explore the entire gastrointestinal tract. The aim of this study was to assess the applicability of CCE as pan-endoscopy. Patients and methods Healthy participants received CCE with bowel preparation (bisacodyl, polyethylene electrolyte glycol (PEG) + ascorbic acid) and booster regimen (metoclopramide, oral sulfate solution (OSS)). For each segment of the gastrointestinal tract, the following quality parameters were assessed: cleanliness, transit times, reading times, patient acceptance and safety of the procedure. When all gastrointestinal segments had cleansing score good or excellent, cleanliness of the whole gastrointestinal tract was assessed as good. Participants' expected and perceived burden was assessed by questionnaires and participants were asked to grade the procedure (scale 0-10). All serious adverse events (SAEs) were documented. Results A total of 451 CCE procedures were analyzed. A good cleansing score was achieved in the stomach in 69.6%, in the SB in 99.1 % and in the colon in 76.6 %. Cleanliness of the whole gastrointestinal tract was good in 52.8 % of the participants. CCE median transit time of the whole gastrointestinal tract was 583 minutes IQR 303-659). The capsule reached the descending colon in 94.7 %. Median reading time per procedure was 70 minutes (IQR 57-83). Participants graded the procedure with a 7.8. There were no procedure-related SAEs. Conclusions CCE as pan-endoscopy has shown to be a safe procedure with good patient acceptance. When cleanliness of all gastrointestinal segments per patient, completion rate and reading time will be improved, CCE can be applied as a good non-invasive alternative to evaluate the gastrointestinal tract.
| S-EPMC8670994 | biostudies-literature
Project description:Small bowel capsule endoscopy is considered a first-line diagnostic tool for the investigation of small bowel diseases. Gastroenterological and endoscopic societies have proposed and established measures known as quality indicators, quality measures or performance measures for the majority of endoscopic procedures, in order to ensure competence, healthcare quality and define areas requiring improvement. However, there is a paucity of publications describing small bowel capsule endoscopy quality indicators. Hereby, we attempt to identify and describe a number of pre-procedure, intra-procedure and post-procedure quality indicators, regarding process measures in small bowel capsule endoscopy, after a comprehensive review of the literature.
| S-EPMC6064801 | biostudies-literature
Project description:ObjectiveIn primary care, assessing which patients with bowel symptoms harbour significant disease (cancer, higher-risk adenoma or IBD) is difficult. We studied the diagnostic accuracies of faecal haemoglobin (FHb) and faecal calprotectin (FC) in a cohort of symptomatic patients.DesignFrom October 2013 to March 2014, general practitioners were prompted to request FHb and FC when referring patients with bowel symptoms to secondary care. Faecal samples were analysed for haemoglobin (EIKEN OC-Sensor io) and calprotectin (BÜHLMANN Calprotectin ELISA). Patients triaged to endoscopy were investigated within 6 weeks. All clinicians and endoscopists were blind to the faecal test results. The diagnostic accuracies of FHb and FC for identification of significant bowel disease were assessed.Results1043 patients returned samples. FHb was detectable in 57.6% (median 0.4 µg/g, 95% CI 0.4 to 0.8; range 0-200). FC at 50 µg/g or above was present in 60.0%. 755 patients (54.6% women, median age 64 years (range 16-90, IQR 52-73)) returned samples and completed colonic investigations. 103 patients had significant bowel disease; the negative predictive values of FHb for colorectal cancer, higher-risk adenoma and IBD were 100%, 97.8% and 98.4%, respectively. Using cut-offs of detectable FHb and/or 200 µg/g FC detected two further cases of IBD, one higher-risk adenoma and no additional cancers.ConclusionsIn primary care, undetectable FHb is a good 'rule-out' test for significant bowel disease and could guide who requires investigation.
| S-EPMC5036251 | biostudies-literature