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.
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.
Project description:Background and study aims Adherence to colorectal cancer (CRC) screening is still unsatisfactory in many countries, thereby limiting prevention of CRC. Colon capsule endoscopy (CCE), a minimally invasive procedure, could be an alternative to fecal immunochemical tests or optical colonoscopy for CRC screening, and might increase adherence in CRC screening. This systematic review and meta-analysis evaluates the diagnostic accuracy of CCE compared to optical colonoscopy (OC) as the gold standard, adequacy of bowel preparation regimes and the patient perspective on diagnostic measures. Methods We conducted a systematic literature search in PubMed, EMBASE and the Cochrane Register for Clinical Trials. Pooled estimates for sensitivity, specificity and the diagnostic odds ratio with their respective 95 % confidence intervals (CI) were calculated for studies providing sufficient data. Results Of 840 initially identified studies, 13 were included in the systematic review and up to 9 in the meta-analysis. The pooled sensitivities and specificities for polyps ≥ 6 mm were 87 % (95 % CI: 83 %-90 %) and 87 % (95 % CI: 76 %-93 %) in 8 studies, respectively. For polyps ≥ 10 mm, the pooled estimates for sensitivities and specificities were 87 % (95 % CI: 83 %-90 %) and 95 % (95 % CI: 92 %-97 %) in 9 studies, respectively. A patients' perspective was assessed in 31 % (n = 4) of studies, and no preference of CCE over OC was reported. Bowel preparation was adequate in 61 % to 92 % of CCE exams. Conclusions CCE provides high diagnostic accuracy in an adequately cleaned large bowel. Conclusive findings on patient perspectives require further studies to increase acceptance/adherence of CCE for CRC screening.
Project description:Bowel preparation regimens for colon capsule endoscopy are not yet standardized since they are not well optimized. The aim of the present study was to evaluate the feasibility of a novel low-volume and sodium phosphate-free bowel preparation regimen for colon capsule endoscopy. A total of 31 patients were prospectively enrolled. In the novel regimen, on the day prior to examination, a low-fiber diet was permitted, 5 mg mosapride citrate was administered twice (1 h prior to lunch and supper) and 1 l polyethylene glycol was administered in the evening. On the day of the examination, an additional 1 l polyethylene glycol, 5 mg mosapride citrate and 200 mg simethicone were administered before capsule ingestion. Polyethylene glycol booster (0.5 l) was administered twice, at 1 and 4 h following capsule ingestion. Colon cleansing levels, ileocecal valve transit time and completion rate were evaluated. A total of 29 patients were included in the final analysis, 90% of whom achieved adequate preparation of the overall colon. Ileocecal valve transit time was 2.35±0.82 h and completion rate was 79.3%. The results revealed that the novel low-volume and sodium phosphate-free bowel preparation regimen for colon capsule endoscopy was feasible, with adequate colon cleansing and completion rates, and has the potential to be used as an alternative regimen.
Project description:BackgroundCapsule endoscopy (CE) is frequently hindered by intra-luminal debris. Our aim was to determine whether a combination bowel preparation would improve small-bowel visualization, diagnostic yield, and the completion rate of CE.MethodsSingle-blind, prospective randomized-controlled study of outpatients scheduled for CE. Bowel-preparation subjects ingested 2 L of polyethylene glycol solution the night prior to CE, 5 mL simethicone and 5 mg metoclopramide 20 minutes prior to CE and laid in the right lateral position 30 minutes after swallowing CE. Controls had no solid food after 7 p.m. the night prior to CE and no liquids 4 hours prior to CE. Participants completed a satisfaction survey. Capsule readers completed a small-bowel-visualization assessment.ResultsFifty patients were prospectively enrolled (56% female) with a median age of 54.4 years and 44 completed the study (23 patients in the control group and 21 in the preparation group). There was no significant difference between groups on quartile-based small-bowel visualization (all P > 0.05). There was no significant difference between groups in diagnostic yield (P = 0.69), mean gastric (P = 0.10) or small-bowel transit time (P = 0.89). The small-bowel completion rate was significantly higher in the preparation group (100% vs 78%; P = 0.02). Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%; P = 0.01).ConclusionsCombined bowel preparation did not improve small-bowel visualization but did significantly increase patient discomfort. The CE completion rate improved in the preparation group but the diagnostic yield was unaffected. Based on our findings, a bowel preparation prior to CE does not appear to improve CE performance and results in decreased patient satisfaction (ClinicalTrials.gov, No. NCT01243736).
Project description:Background and study aims ?To achieve a complete colon capsule endoscopy, the entire colon must be visualized, clean and filled with clear fluids. The primary aim was to compare three booster regimens in colon capsule endoscopy in achieving capsule excretion within recording time. Secondary aims were quality of bowel cleansing and completion rate (both adequate cleansing and capsule excretion). Patients and methods ?Patients scheduled for follow-up colonoscopy due to previous neoplastic findings or familial history of colorectal cancer aged 18 to 70 years were eligible. Bowel preparation was 2-L split doses of polyethylene glycol. Patients were randomized to three booster regimens of either polyethylene glycol (Group A), sulfate-based solution (Group B) or polyethylene glycol with iodine oral contrast (Group C). Results ?One hundred eighty participants were included and randomized into three groups of 60.?Capsule excretion was 70?% (95?% CI: 58?-?80) in Group A, 73?% (95?% CI: 61?-?83) in Group B and in 68?% (95?% CI: 56?-?79) in Group C, no statistically significant differences. Bowel cleansing grade was statistically significant better in Group B compared to Group A ( P ?=?0.03), but there were no statistically significant differences between Groups C and A ( P ?=?0.40). Complete examination rate was 65?% (95?% CI: 53?-?77), 72?% (95?% CI: 61?-?83) and 62?% (95?% CI: 50?-?74) in Group A, B and C respectively, not statistically significant different. Conclusions ?Sulfate-based solution resulted in statistically significant better bowel cleansing compared to polyethylene glycol. Overall the excretion and completion rate was suboptimal. Achieving a high completion rate using patient-tolerable and low-risk compounds is still a challenge.
Project description:Several studies have evaluated the utility of double-balloon enteroscopy (DBE) and capsule endoscopy (CE) for patients with small-bowel disease showing inconsistent results. The aim of this study was to determine the sensitivity and specificity of overtube-assisted enteroscopy (OAE) as well as the diagnostic concordance between OAE and CE for small-bowel polyps and tumors.We conducted a systematic review and meta-analysis of studies in which the results of OAE were compared with the results of CE for the evaluation of small-bowel polyps and tumors. When data for surgically resected lesions were available, the histopathological results of OAE and surgical specimens were compared. The sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio for the diagnosis of small-bowel polyps and tumors were analyzed. Secondarily, the rates of diagnostic concordance and discordance between OAE and CE were calculated.There were 15 full-length studies with a total of 821 patients that met the inclusion criteria. The pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio were as follows: 0.89 (95 % confidence interval [CI] 0.84 - 0.93), with heterogeneity χ(2) = 41.23 (P = 0.0002) and inconsistency (I (2)) = 66.0 %; 0.97 (95 %CI 0.95 - 0.98), with heterogeneity χ(2) = 45.27 (P = 0.07) and inconsistency (I (2)) = 69.1 %; 16.61 (95 %CI 3.74 - 73.82), with heterogeneity Cochrane's Q = 225.19 (P < 0.01) and inconsistency (I (2)) = 93.8 %; and 0.14 (95 %CI 0.05 - 0.35), with heterogeneity Cochrane's Q = 81.01 (P < .01) and inconsistency (I (2)) = 82.7 %, respectively. A summary receiver operating characteristic curve (SROC) curve was constructed, and the area under the curve (AUC) was 0.97.OAE is an accurate test for the detection of small-bowel polyps and tumors. OAE and CE have a high diagnostic concordance rate for small-bowel polyps and tumors. This study was registered in the PROSPERO international database (www.crd.york.ac.uk/prospero/) with the study number CRD42015016000.
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.
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.
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.