Standard versus Endocuff versus cap-assisted colonoscopy for adenoma detection: A randomised controlled clinical trial.
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ABSTRACT: Background and aims
Adenoma detection rate (ADR) in colon cancer screening is most important for cancer prophylaxis. This work is the first three-armed randomised controlled clinical trial aimed at comparing a head-to-head setting standard colonoscopy (SC) with Endocuff-assisted colonoscopy (EC) and cap-assisted colonoscopy (CAC) for improvement of ADR.Methods
Patients from Poland and Germany with independent indication for colonoscopy were randomised into three arms of this trial: EC, CAC and SC. Exclusion criteria were age <18 years, active Crohn's disease or ulcerative colitis, known stenosis and post-colonic resection status.Results
A total of 585 patients (195 SC, 189 EC and 186 CAC) were enrolled in this study. Indications were not different between the groups (colorectal cancer screening 51%, diagnostic colonoscopy in 31% and post-polypectomy follow-up in 18%; p = 0.94). Withdrawal time was a mean of 7 min in all groups (p = 0.658), and bowel preparation did not differ between the groups. The time to reach the caecum was significantly reduced when using the cap (a mean of 6 min for CAC vs. 7 min for SC; p = 0.0001). There was no significant difference in the primary outcome of the ADR between the groups (EC 32%, CAC 30%, SC 30%; p = 0.815). EC proved to be superior (EC vs. SC) in the sigmoid colon and transverse colon for polyp detection.Conclusion
The use of EC increased the total number of polyps seen during colonoscopy. In contrast to recent studies, no significant improvement of the ADR was detected.
SUBMITTER: Floer M
PROVIDER: S-EPMC8259258 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Objectives and study aim Colonoscopy prevents colorectal cancer by removing adenomatous polyps, but missed adenomas lead to interval cancers. Different devices have been used to increase adenoma detection rates (ADR). Two such devices of interest are the transparent cap (Olympus) and Endocuff (ARC Medical). Our study aimed to compare differences in ADR between Endocuff-assisted colonoscopy (EAC), cap-assisted colonoscopy (CAC) and standard colonoscopy (SC). Patients and methods A sample size of 126 subjects was calculated to determine an effect size of 30 %. Patients undergoing screening or surveillance colonoscopy between March 2016 and January 2017 were randomized to SC, CAC or EAC groups. Three experienced endoscopists performed all colonoscopies. Patient demographics, procedure indication, Boston Bowel Prep Score (BBPS), withdrawal time, polyp size, location, histopathology, were analyzed. Results There was no difference in ADR (52 %, 40 % and 54 %) in the SC, CAC and EAC groups respectively ( P = 0.4). Similar findings were also observed for proximal ADR (45 %, 35 %, and 50 %, P = 0.4) and SSA detection rate (16 %, 14 %, and 23 %, P = 0.5). EAC detected higher mean ADR per colonoscopy compared to CAC (1.70 vs 0.76, P = 0.01). However, there was no significant difference in mean ADR per positive colonoscopy (2.08, 1.63, and 2.59, P = 0.21). Conclusion In a randomized controlled trial comparing AC to CAC and SC, neither device conferred additional benefits in ADR among high detectors. When comparing each device, EAC may be better than CAC at detecting more total adenomas.
| S-EPMC6877415 | biostudies-literature
Project description:ObjectivesThe Endocuff is a device mounted on the tip of the colonoscope to help flatten the colonic folds during withdrawal. This study aimed to compare the adenoma detection rates between Endocuff-assisted (EC) colonoscopy and standard colonoscopy (SC).MethodsThis randomized prospective multicenter trial was conducted at four academic endoscopy units in Germany.Participants500 patients (235 males, median age 64[IQR 54-73]) for colon adenoma detection purposes were included in the study. All patients were either allocated to EC or SC. The primary outcome measure was the determination of the adenoma detection rates (ADR).ResultsThe ADR significantly increased with the use of the Endocuff compared to standard colonoscopy (35.4%[95% confidence interval{CI} 29-41%] vs. 20.7%[95%CI 15-26%], p<0.0001). Significantly more sessile polyps were detected by EC. Overall procedure time and withdrawal time did not differ. Caecal and ileum intubation rates were similar. No major adverse events occurred in both groups. In multivariate analysis, age (odds ratio [OR] 1.03; 95%[CI] 1.01-1.05), male sex (OR 1.74; 95%CI 1.10-2.73), withdrawal time (OR 1.16; 95%CI 1.05-1.30), procedure time (OR 1.07; 95%CI 1.04-1.10), colon cleanliness (OR 0.60; 95%CI 0.39-0.94) and use of Endocuff (OR 2.09; 95%CI 1.34-3.27) were independent predictors of adenoma detection rates.ConclusionsEC increases the adenoma detection rate by 14.7%(95%CI 6.9-22.5%). EC is safe, effective, easy to handle and might reduce colorectal interval carcinomas.Trial registrationClinicalTrials.gov NCT02034929.
| S-EPMC4255000 | biostudies-literature
Project description:OBJECTIVE:Low adenoma detection rates (ADR) are linked to increased postcolonoscopy colorectal cancer rates and reduced cancer survival. Devices to enhance mucosal visualisation such as Endocuff Vision (EV) may improve ADR. This multicentre randomised controlled trial compared ADR between EV-assisted colonoscopy (EAC) and standard colonoscopy (SC). DESIGN:Patients referred because of symptoms, surveillance or following a positive faecal occult blood test (FOBt) as part of the Bowel Cancer Screening Programme were recruited from seven hospitals. ADR, mean adenomas per procedure, size and location of adenomas, sessile serrated polyps, EV removal rate, caecal intubation rate, procedural time, patient experience, effect of EV on workload and adverse events were measured. RESULTS:1772 patients (57% male, mean age 62 years) were recruited over 16 months with 45% recruited through screening. EAC increased ADR globally from 36.2% to 40.9% (P=0.02). The increase was driven by a 10.8% increase in FOBt-positive screening patients (50.9% SC vs 61.7% EAC, P<0.001). EV patients had higher detection of mean adenomas per procedure, sessile serrated polyps, left-sided, diminutive, small adenomas and cancers (cancer 4.1% vs 2.3%, P=0.02). EV removal rate was 4.1%. Median intubation was a minute quicker with EAC (P=0.001), with no difference in caecal intubation rate or withdrawal time. EAC was well tolerated but caused a minor increase in discomfort on anal intubation in patients undergoing colonoscopy with no or minimal sedation. There were no significant EV adverse events. CONCLUSION:EV significantly improved ADR in bowel cancer screening patients and should be used to improve colonoscopic detection. TRIAL REGISTRATION NUMBER:NCT02552017, Results; ISRCTN11821044, Results.
| S-EPMC6352411 | biostudies-literature
Project description:AimTo study the significance of cap-fitted colonoscopy in improving cecal intubation time and polyp detection rate.MethodsThis study was a prospective randomized controlled trial conducted from March 2008 to February 2009 in a tertiary referral hospital at Sydney. The primary end point was cecal intubation time and the secondary endpoint was polyp detection rate. Consecutive cases of total colonoscopy over a 1-year period were recruited. Randomization into either standard colonoscopy (SC) or cap-assisted colonoscopy (CAC) was performed after consent was obtained. For cases randomized to CAC, one of the three sizes of cap was used: D-201-15004 (with a diameter of 15.3 mm), D-201-14304 (14.6 mm) and D-201-12704 (13.0 mm). All of these caps were produced by Olympus Medical Systems, Japan. Independent predictors for faster cecal time and better polyp detection rate were also determined from this study.ResultsThere were 200 cases in each group. There was no significant difference in terms of demographic characteristics between the two groups. CAC, when compared to the SC group, had no significant difference in terms of cecal intubation rate (96.0% vs 97.0%, P = 0.40) and time (9.94 +/- 7.05 min vs 10.34 +/- 6.82 min, P = 0.21), or polyp detection rate (32.8% vs 31.3%, P = 0.75). On the subgroup analysis, there was no significant difference in terms of cecal intubation time by trainees (88.1% vs 84.8%, P = 0.40), ileal intubation rate (82.5% vs 79.0%, P = 0.38) or total colonoscopy time (23.24 +/- 13.95 min vs 22.56 +/- 9.94 min, P = 0.88). On multivariate analysis, the independent determinants of faster cecal time were consultant-performed procedures (P < 0.001), male patients (P < 0.001), non-usage of hyoscine (P < 0.001) and better bowel preparation (P = 0.01). The determinants of better polyp detection rate were older age (P < 0.001), no history of previous abdominal surgery (P = 0.04), patients not having esophagogastroduodenoscopy in the same setting (P = 0.003), trainee-performed procedures (P = 0.01), usage of hyoscine (P = 0.01) and procedures performed for polyp follow-up (P = 0.01). The limitations of the study were that it was a single-center experience, no blinding was possible, and there were a large number of endoscopists.ConclusionCAC did not significantly different from SC in term of cecal intubation time and polyp detection rate.
| S-EPMC2923764 | biostudies-literature
Project description:BackgroundRecent prospective randomized controlled trials have evaluated deep convolutional neural network (CNN) based computer aided detection (CADe) of lesions in real-time colonoscopy. We conducted this meta-analysis to compare the adenoma detection rate (ADR) of deep CNN based CADe assisted colonoscopy to standard colonoscopy (SC) from randomized controlled trials (RCTs).MethodsMultiple databases were searched (from inception to May 2020) and parallel RCTs that compared deep CNN based CADe assisted colonoscopy to SC were included for this analysis. Using Mantel-Haenzel (M-H) random effects model, pooled risk ratios (RR) and mean difference (MD) were calculated. In between study heterogeneity was assessed by I2% values. Outcomes assessed included other per patient adenoma parameters.FindingsSix RCTs were included in our final analysis that utilized deep CNN based CADe system in real-time colonoscopy. Total numbers of patients assessed were 4962 (2480 in CADe and 2482 in SC group). CADe based colonoscopy demonstrated statistically higher pooled ADR, RR=1.5 (95% CI 1.3-1.72), p<0.0001, I2=56%; and pooled PDR, RR=1.42 (95% CI 1.33-1.51), p<0.00001, I2=9%; when compared to SC. Per patient adenoma detection parameters were significantly better with CADe colonoscopy when compared to SC, with increased scope withdrawal time (mean difference = 0.38, 95% CI 0.05-0.72, p = 0.02).InterpretationBased on our meta-analysis, deep CNN based CADe colonoscopy achieved significantly higher ADR metrics, albeit with increased scope withdrawal time when compared to SC.
| S-EPMC7691740 | biostudies-literature
Project description:Although colonoscopy is the accepted standard for detection of colorectal adenomas and cancers, many adenomas and some cancers are missed. To avoid interval colorectal cancer, the adenoma miss rate of colonoscopy needs to be reduced by improvement of colonoscopy technique and imaging capability. We aimed to compare the adenoma miss rates of full-spectrum endoscopy colonoscopy with those of standard forward-viewing colonoscopy.We did an international, multicentre, randomised trial at three sites in Israel, one site in the Netherlands, and two sites in the USA between Feb 1, 2012, and March 31, 2013. Patients aged 18-70 years referred for colorectal cancer screening, polyp surveillance, or diagnostic assessment underwent same-day, back-to-back tandem colonoscopy with standard forward-viewing colonoscope and the full-spectrum endoscopy colonoscope. The patients were randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure was done first. The endoscopist was masked to group allocation until immediately before the start of colonoscopy examinations; patients were not masked. The primary endpoint was adenoma miss rates. We did per-protocol analyses. This trial is registered with ClinicalTrials.gov, number NCT01549535.197 participants were enrolled. 185 participants were included in the per-protocol analyses: 88 (48%) were randomly assigned to receive standard forward-viewing colonoscopy first, and 97 (52%) to receive full-spectrum endoscopy colonoscopy first. By per-lesion analysis, the adenoma miss rate was significantly lower in patients in the full-spectrum endoscopy group than in those in the standard forward-viewing procedure group: five (7%) of 67 vs 20 (41%) of 49 adenomas were missed (p<0·0001). Standard forward-viewing colonoscopy missed 20 adenomas in 15 patients; of those, three (15%) were advanced adenomas. Full-spectrum endoscopy missed five adenomas in five patients in whom an adenoma had already been detected with first-pass standard forward-viewing colonoscopy; none of these missed adenomas were advanced. One patient was admitted to hospital for colitis detected at colonoscopy, whereas five minor adverse events were reported including vomiting, diarrhoea, cystitis, gastroenteritis, and bleeding.Full-spectrum endoscopy represents a technology advancement for colonoscopy and could improve the efficacy of colorectal cancer screening and surveillance.EndoChoice.
| S-EPMC4062184 | biostudies-literature
Project description:BackgroundColonic transendoscopic enteral tubing (TET) requires double cecal intubation, raising a common concern of how to save cecal intubation time and make the tube stable. We hypothesized that cap-assisted colonoscopy (CC) might reduce the second cecal intubation time and bring potential benefits during the TET procedure.AimTo investigate if CC can decrease the second cecal intubation time compared with regular colonoscopy (RC).MethodsThis prospective multicenter, randomized controlled trial was performed at four centers. Subjects ? 7 years needing colonic TET were recruited from August 2018 to January 2020. All subjects were randomly assigned to two groups. The primary outcome was the second cecal intubation time. Secondary outcomes included success rate, insertion pain score, single clip fixation time, purpose and retention time of TET tube, length of TET tube inserted into the colon, and all procedure-related (serious) adverse events.ResultsA total of 331 subjects were randomized to the RC (n = 165) or CC (n = 166) group. The median time of the second cecal intubation was significantly shorter for CC than RC (2.2 min vs 2.8 min, P < 0.001). In patients with constipation, the median time of second cecal intubation in the CC group (n = 50) was shorter than that in the RC group (n = 43) (2.6 min vs 3.8 min, P = 0.004). However, no difference was observed in the CC (n = 42) and RC (n = 46) groups of ulcerative colitis patients (2.0 min vs 2.5 min, P = 0.152). The insertion pain score during the procedure in CC (n = 14) was lower than that in RC (n = 19) in unsedated colonoscopy (3.8 ± 1.7 vs 5.4 ± 1.9; P = 0.015). Multivariate analysis revealed that only CC (odds ratio [OR]: 2.250, 95% confidence interval [CI]: 1.161-4.360; P = 0.016) was an independent factor affecting the second cecal intubation time in difficult colonoscopy. CC did not affect the colonic TET tube's retention time and length of the tube inserted into the colon. Moreover, multivariate analysis found that only endoscopic clip number (OR: 2.201, 95%CI: 1.541-3.143; P < 0.001) was an independent factor affecting the retention time. Multiple regression analysis showed that height (OR: 1.144, 95%CI: 1.027-1.275; P = 0.014) was the only independent factor influencing the length of TET tube inserted into the colon in adults.ConclusionCC for colonic TET procedure is a safe and less painful technique, which can reduce cecal intubation time.
| S-EPMC7584059 | biostudies-literature
Project description:Background and study aims Endocuff Vision (ECV) increases adenoma detection rate (ADR) in randomized clinical trials; however, observational effectiveness data are lacking. We evaluated the effectiveness, safety, and practical aspects of ECV use in a large screening-related real-world cohort. Patients and methods In this observational study, patients undergoing screening-related colonoscopy from November 2018 to April 2019 comprised the baseline period, and those undergoing it from June to November 2019 comprised the ECV period, where ECV use was discretionary. The primary outcome was ADR, compared: 1) between ECV use and standard colonoscopy across both periods; and 2) between time periods. Secondary outcomes included indication-specific ADR, sessile serrated ADR (SSADR), cecal intubation rate (CIR), procedure times, patient comfort scores, and sedation use. Multilevel logistic regression was performed, yielding adjusted odds ratios (AOR) with 95 % confidence intervals (CIs). Results In 15,814 colonoscopies across both time periods, ADR was 46.7 % with standard colonoscopy and 54.6 % when ECV was used ( P < 0.001). Endoscopists used ECV in 77.6 % of procedures in the ECV period, during which overall ADR rose to 53.2 % compared to 46.3 % in the baseline period ( P < 0.001). ECV use was significantly associated with higher ADR (AOR 1.24, 95 % CI 1.10 to 1.40) after adjusting for relevant covariates including time period. ECV use did not result in lower CIR, longer procedure time, increased sedation use, or poorer comfort scores. Conclusions ECV use is associated with improved ADR without negatively impacting other key procedure and patient-related factors. Future studies should evaluate the cost-effectiveness of incorporating ECV into routine screening-related practice.
| S-EPMC8545492 | biostudies-literature
Project description:OBJECTIVE:Suboptimal adenoma detection rate (ADR) at colonoscopy is associated with increased risk of interval colorectal cancer. It is uncertain how ADR might be improved. We compared the effect of leadership training versus feedback only on colonoscopy quality in a countrywide randomised trial. DESIGN:40 colonoscopy screening centres with suboptimal performance in the Polish screening programme (centre leader ADR ? 25% during preintervention phase January to December 2011) were randomised to either a Train-Colonoscopy-Leaders (TCLs) programme (assessment, hands-on training, post-training feedback) or feedback only (individual quality measures). Colonoscopies performed June to December 2012 (early postintervention) and January to December 2013 (late postintervention) were used to calculate changes in quality measures. Primary outcome was change in leaders' ADR. Mixed effect models using ORs and 95% CIs were computed. RESULTS:The study included 24,582 colonoscopies performed by 38 leaders and 56,617 colonoscopies performed by 138 endoscopists at the participating centres. The absolute difference between the TCL and feedback groups in mean ADR improvement of leaders was 7.1% and 4.2% in early and late postintervention phases, respectively. The TCL group had larger improvement in ADR in early (OR 1.61; 95% CI 1.29 to 2.01; p<0.001) and late (OR 1.35; 95% CI 1.10 to 1.66; p=0.004) postintervention phases. In the late postintervention phase, the absolute difference between the TCL and feedback groups in mean ADR improvement of entire centres was 3.9% (OR 1.25; 95% CI 1.04 to 1.50; p=0.017). CONCLUSIONS:Teaching centre leaders in colonoscopy training improved important quality measures in screening colonoscopy. TRIAL REGISTRATION NUMBER:NCT01667198.
| S-EPMC4819605 | biostudies-literature
Project description:Background and study aims The newly introduced G-EYE colonoscope (G-EYE) employs a balloon, installed at the bending section of a standard colonoscope (SC), for increasing adenoma detection and stabilizing the colonoscope tip during intervention. This retrospective work explores the effect of introducing G-EYE into an SC endoscopy room, in terms of adenoma detection and polyp removal time. Patients and methods This was a single-center, retrospective study. Historical data from patients who underwent colonoscopy prior to, and following, introduction of G-EYE into a particular endoscopy room were collected and analyzed to determine adenoma detection rate (ADR), adenoma per patient (APP), and polyp removal time (PRT), in each of the SC and G-EYE groups. Results Records of 1362 patients who underwent SC and 1433 subsequent patients who underwent G-EYE colonoscopy in the same endoscopy unit by the same endoscopists were analyzed. Following G-EYE introduction, overall ADR increased by 37.5 % ( P < 0.0001) from 39.2 % to 53.9 %, the serrated adenoma rate increased by 47.3 % from 27.9 % to 41.1 % ( P < 0.0001), and the APP increased by 50.6 % from 0.79 to 1.19 ( P < 0.0001). The number of advanced adenomas increased by 32.7 %, from 19.6 % to 26.0 % of all adenomas ( P < 0.0001). With G-EYE, average PRT was reduced overall by 29.5 % ( P < 0.0001), and particularly for endoscopic mucosal resection (EMR) by 37.5 % for polyps measuring ≥ 5 mm to ≤ 20 mm ( P < 0.0001) and by 29.4 % for large polyps > 20 mm ( P < 0.0001). Conclusions Introduction of G-EYE to an SC endoscopy room yielded considerable increase in ADR and notable reduction in PRT, particularly with the EMR technique. G-EYE balloon colonoscopy might increase the effectiveness of colorectal cancer screening and surveillance colonoscopy, and can shorten the time of endoscopic intervention.
| S-EPMC10558257 | biostudies-literature