Adenoma detection by Endocuff-assisted versus standard colonoscopy in an organized screening program: the “ItaVision” Randomized Controlled Trial

Endoscopy ◽  
2021 ◽  
Author(s):  
Manuel Zorzi ◽  
Cesare Hassan ◽  
Jessica Battagello ◽  
Giulio Antonelli ◽  
Maurizio Pantalena ◽  
...  
Keyword(s):  
Screening Program ◽  
Controlled Trial ◽  
Withdrawal Time ◽  
Adenoma Detection ◽  
Organized Screening Program ◽  
Immunochemical Test ◽  
Medical Design ◽  
Standard Colonoscopy ◽  
To Receive ◽  
Screening History

Objective Endocuff Vision (EV, Arc Medical Design Ltd., Leeds, England) has shown to increase mucosal exposure, and consequently adenoma detection rate (ADR), during colonoscopy. This nationwide multicentre study assessed possible benefits and harms of implementing EV in a Faecal Immunochemical Test (FIT)-based screening program. Design Patients undergoing colonoscopy after a FIT+ test were randomised 1:1 to receive colonoscopy with EV or standard colonoscopy, stratified by gender, age, and screening history. Primary outcome was ADR, Secondary outcomes were ADR stratified by endoscopists’ ADR, advanced ADR (AADR), adenoma per colonoscopy (APC), withdrawal time (WT), and adverse events (AE). Results Overall, 1,864 patients were enrolled in 13 centres. After exclusions, 1,813 (males: 53.7%; mean age: 60.1 years) were randomised, 908 in the EV arm and 905 in the control. ADR was significantly higher in the EV arm (47.8% vs 40.8%; RR 1.17, 95%CI 1.06-1.30) with no differences between arms regarding size or morphology. When stratifying for endoscopists’ ADR, only low detectors (ADR< 33.3%) showed a statistically significant ADR increase (EV = 41.1%, 95%CI 35.7-46.7 vs control = 26%, 95%CI 21.3-31.4 . AADR (24.8% vs 20.5%, RR 1.21; 95%CI 1.02-1.43) and APC (0.94 vs. 0.77, p=0.001) were higher in the EV arm. WT and AE were similar between arms. Conclusion EV increased ADR in a FIT-based screening program, supporting a complete exploration of colonic mucosa. Its utility was highest among endoscopists with a low ADR. ClinicalTrial.gov NCT03612674

scholarly journals Standard versus Endocuff versus cap-assisted colonoscopy for adenoma detection: A randomised controlled clinical trial

2020 ◽  
pp. 205064062098295
Author(s):  
Martin Floer ◽  
Laura Tschaikowski ◽  
Michael Schepke ◽  
Radoslaw Kempinski ◽  
Katarzyna Neubauer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cancer Screening ◽  
Controlled Clinical Trial ◽  
Polyp Detection ◽  
Withdrawal Time ◽  
Adenoma Detection ◽  
Significant Difference ◽  
Randomised Controlled Clinical Trial ◽  
Randomised Controlled ◽  
Standard Colonoscopy

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 seven minutes 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 six minutes for CAC vs. seven minutes 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.

scholarly journals Outcomes of colonoscopy with non-anesthesiologist-administered propofol (NAAP): an equivalence trial

2021 ◽  
Vol 09 (07) ◽  
pp. E1070-E1076
Author(s):  
Marco Alburquerque ◽  
Antonella Smarrelli ◽  
Julio Chevarria Montesinos ◽  
Sergi Ortega Carreño ◽  
Ana Zaragoza Fernandez ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Screening Program ◽  
Complication Rates ◽  
Withdrawal Time ◽  
Equivalence Trial ◽  
Crc Screening ◽  
Intention To Treat ◽  
Adenoma Detection ◽  
Group A ◽  
Cecal Intubation Rate

Abstract Background and study aims Efficacy and safety of NAAP for gastrointestinal endoscopy have been widely documented, although there is no information about the outcomes of colonoscopy when the endoscopist supervises the sedation. In this context, the aim of this trial was to determine the equivalence of adenoma detection rate (ADR) in colorectal cancer (CRC) screening colonoscopies performed with non-anesthesiologist-administered propofol (NAAP) and performed with monitored anesthesia care (MAC). Patients and methods This was a single-blind, non-randomized controlled equivalence trial that enrolled adults from a national CRC screening program (CRCSP). Patients were blindly assigned to undergo either colonoscopy with NAAP or MAC. The main outcome measure was the ADR in CRCSP colonoscopies performed with NAAP. Results We included 315 patients per group. The median age was 59.76 ± 5.81 years; 40.5 % of patients were women. The cecal intubation rate was 97 %, 81.8 % of patients had adequate bowel preparation, withdrawal time was > 6 minutes in 98.7 %, and the median global exploration time was 24.25 ± 8.86 minutes (range, 8–70 minutes). The ADR was 62.9 % and the complication rate (CR) was 0.6 %. Analysis by intention-to-treat showed an ADR in the NAAP group of 64.13 % compared with 61.59 % in the MAC group, a difference (δADR) of 2.54 %, 95 %CI: −0.10 to 0.05. Analysis by per-protocol showed an ADR in the NAAP group of 62.98 %, compared with 61.94 % in the MAC group, δADR: 1.04 %, 95 %CI: −0.09 to 0.07. There was no difference in CR (NAAP: 0,63 vs. MAC: 0.63); P = 1.0. Conclusions ADR in colorectal cancer screening colonoscopies performed with NAAP was equivalent to that in those performed with MAC. Similarly, there was no difference in complication rates.

Endocuff vision-assisted vs. standard polyp resection in the colorectum (the EVASTA study): a prospective randomized study

Endoscopy ◽  
2019 ◽  
Vol 52 (01) ◽  
pp. 45-51 ◽  
Author(s):  
Guido von Figura ◽  
Moritz Hasenöhrl ◽  
Bernhard Haller ◽  
Alexander Poszler ◽  
Jörg Ulrich ◽  
...  
Keyword(s):  
Randomized Study ◽  
Colorectal Polyps ◽  
University Hospital ◽  
Standard Group ◽  
Withdrawal Time ◽  
Detection Rates ◽  
Adenoma Detection ◽  
Adenoma Detection Rates ◽  
Standard Colonoscopy ◽  
The Impact

Abstract Background Cap-assisted colonoscopy is frequently used to facilitate adenoma detection during endoscopy. However, data on how cap assistance influences polyp resection are scarce. We aimed to evaluate the impact of cap assistance with the Endocuff vision device (EVD) on the resection time for colorectal polyps in patients undergoing colonoscopy. Methods A randomized, prospective study was performed in a university hospital in Germany. A total of 250 patients were randomly assigned 1:1 to undergo either colonoscopy with the EVD (EVD arm) or standard colonoscopy without the use of a cap (standard arm). The primary outcome was the average duration of polypectomy. Secondary outcomes included adenoma detection rate, cecal and ileal intubation times, and propofol dosage. Results The use of EVD led to a significant reduction in the median polypectomy time in the EVD vs. standard arm (54 vs. 80 seconds, respectively; P = 0.02). This effect was strongest for polyps ≥ 6 mm. Compared with the standard group, Endocuff assistance also resulted in a shorter cecal intubation time (6 vs. 8 minutes; P = 0.03) and overall colonoscopy time (23 vs. 27 minutes; P = 0.02). In contrast, no difference in withdrawal time was observed. The polyp and adenoma detection rates did not differ significantly between the two groups. Conclusion Endocuff-assisted colonoscopy reduces the duration of polypectomy, which may be due to a more stable scope position during resection. Further studies are needed to investigate whether comparable effects will be seen for other interventions, such as clipping or biopsy sampling.

scholarly journals Comparison of colon adenoma detection rates using cap-assisted and Endocuff-assisted colonoscopy: a randomized controlled trial

2019 ◽  
Vol 07 (12) ◽  
pp. E1585-E1591 ◽  
Author(s):  
Joseph Marsano ◽  
Sheeva Johnson ◽  
Stephanie Yan ◽  
Latifat Alli-Akintade ◽  
Machelle Wilson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Polyp Size ◽  
Withdrawal Time ◽  
Detection Rates ◽  
Patient Demographics ◽  
Randomized Controlled ◽  
Adenoma Detection ◽  
Significant Difference ◽  
Adenoma Detection Rates

Abstract 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.

Diagnostic yield of early repeat colonoscopy after suboptimal bowel preparation in a fecal immunochemical test-based screening program

Endoscopy ◽  
2020 ◽  
Vol 52 (12) ◽  
pp. 1093-1100 ◽  
Author(s):  
Sandra Baile-Maxía ◽  
Carolina Mangas-Sanjuan ◽  
Lucía Medina-Prado ◽  
Juan Martínez-Sempere ◽  
Oscar Murcia ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Screening Program ◽  
Diagnostic Yield ◽  
Fecal Immunochemical Test ◽  
High Rate ◽  
Screening Colonoscopy ◽  
Advanced Adenoma ◽  
Adenoma Detection ◽  
Immunochemical Test ◽  
Repeat Colonoscopy

Abstract Background Current guidelines regarding surveillance after screening colonoscopy assume adequate bowel preparation. However, follow-up intervals after suboptimal cleansing are highly heterogeneous. We aimed to determine the diagnostic yield of early repeat colonoscopy in patients with suboptimal bowel preparation in fecal immunochemical test (FIT)-based screening colonoscopy. Methods An observational study including patients who underwent colonoscopy with suboptimal bowel preparation after positive FIT screening and then repeat colonoscopy within 1 year. Suboptimal preparation was defined as a Boston Bowel Preparation Scale (BBPS) score of 1 in any segment. Patients with a BBPS score of 0 in any segment or incomplete examination were excluded. The adenoma detection rate (ADR), advanced ADR (AADR), and colorectal cancer rate were calculated for the index and repeat colonoscopies. Results Of the 2474 patients with FIT-positive colonoscopy at our center during this period, 314 (12.7 %) had suboptimal preparation. Of the 259 (82.5 %) patients who underwent repeat colonoscopy, suboptimal cleansing persisted in 22 (9 %). On repeat colonoscopy, the ADR was 38.7 % (95 %CI 32.6 % to 44.8 %) and the AADR was 14.9 % (95 %CI 10.5 % to 19.4 %). The per-adenoma miss rate was 27.7 % (95 %CI 24.0 % to 31.6 %), and the per-advanced adenoma miss rate was 17.6 % (95 %CI 13.3 % to 22.7 %). After repeat colonoscopy, the post-polypectomy surveillance recommendation changed from 10 to 3 years in 14.7 % of the patients with previous 10-year surveillance recommendation. Conclusions Patients with suboptimal bowel preparation on FIT-positive colonoscopy present a high rate of advanced adenomas in repeat colonoscopy, with major changes in post-polypectomy surveillance recommendations.

scholarly journals Optimal Timing of Simethicone Supplement for Bowel Preparation: A Prospective Randomized Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Zhen-wen Wu ◽  
Sheng-gang Zhan ◽  
Mei-feng Yang ◽  
Yi-teng Meng ◽  
Feng Xiong ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Controlled Trial ◽  
Optimal Timing ◽  
Intubation Time ◽  
Right Colon ◽  
Cecal Intubation ◽  
Withdrawal Time ◽  
Adenoma Detection ◽  
Cecal Intubation Time ◽  
The Right

Background and Aims. Simethicone (SIM), as an antifoaming agent, has been shown to improve bowel preparation during colonoscopy. However, the optimal timing of SIM addition remained undetermined. We aimed to investigate the optimal timing of SIM addition to polyethylene glycol (PEG) to improve bowel preparation. Methods. Eligible patients were randomly assigned to two groups: the SIM evening group (SIM addition to PEG in the evening of the day prior to colonoscopy) and the SIM morning group (SIM addition to PEG in the morning of colonoscopy). The primary outcome was Bubble Scale (BS). The secondary outcomes were Boston Bowel Preparation Scale (BBPS) and adenoma detection rate (ADR). Results. A total of 419 patients were enrolled in this study. The baseline characteristics of the patients were similar in both groups. No significant differences were observed in terms of BS (8.76 ± 0.90 vs. 8.65 ± 1.16, P  = 0.81), ADR (34.1% vs. 30.8%, P  = 0.47), Boston Bowel Preparation Scale (BBPS) (8.59 ± 0.94 vs. 8.45 ± 1.00, P  = 0.15), and withdrawal time (8.22 ± 2.04 vs. 8.01 ± 2.51, P  = 0.094) between the two groups. Moreover, safety and compliance were similar in both groups. However, the SIM evening group was associated with shorter cecal intubation time (3.80 ± 1.81 vs. 4.42 ± 2.03, P  < 0.001), higher BS (2.95 ± 0.26 vs. 2.88 ± 0.38, P  = 0.04) in the right colon, and diminutive ADR (62.5% vs. 38.6%, P  = 0.022) in the right colon, when compared to the SIM evening group. Conclusions. The SIM addition to PEG in the evening of the day prior to colonoscopy can shorten cecal intubation time and improve BS scores and diminutive ADR of the right colon compared with the SIM addition to PEG in the morning of colonoscopy in bowel preparation.

Impact of sedation on the Performance Indicator of Colonic Intubation

Endoscopy ◽  
2020 ◽  
Author(s):  
Karlijn J. Nass ◽  
Sascha C. van Doorn ◽  
Manon van der Vlugt ◽  
Paul Fockens ◽  
Evelien Dekker
Keyword(s):  
Odds Ratio ◽  
Performance Indicator ◽  
Screening Program ◽  
National Database ◽  
Median Dose ◽  
Cecal Intubation ◽  
Crc Screening ◽  
Adenoma Detection ◽  
Immunochemical Test ◽  
Pathology Data

Abstract Background The Performance Indicator of Colonic Intubation (PICI) is a new measure of high-quality colonic intubation. Adequate PICI was defined as cecal intubation without significant discomfort and use of minimal sedation. This study assessed achievement of PICI within the Dutch colorectal cancer (CRC) screening program, and determined the association between PICI and adenoma detection rate (ADR). PICI achievement when using the Dutch median midazolam dose was also assessed. Methods This retrospective study was conducted within the Dutch fecal immunochemical test-based CRC screening program. Colonoscopy and pathology data were prospectively collected in a national database. Data between January 2016 through January 2018 were analyzed. Adequate PICI was defined as successful cecal intubation, Gloucester Comfort Scale (GCS) of 1 – 3, and use of ≤ 2.5 mg midazolam. Results 107 328 colonoscopies were performed during the study period. Adequate PICI was achieved in 49 500 colonoscopies (46.1 %). In colonoscopies with inadequate PICI, inadequacy was due to higher sedation doses in 87.8 %. Adequate PICI was associated with higher ADR (odds ratio 1.16, 95 % confidence interval 1.12 – 1.20). When using a cutoff of 5 mg midazolam, median dose in this Dutch population, adequate PICI was achieved in 95 410 colonoscopies (88.9  %). Conclusion PICI appeared to be heavily dependent on sedation practice. Because of wide variation in sedation practice between individual endoscopists and countries, the benefit of PICI as a quality indicator is limited.

scholarly journals Endocuff-assisted vs. standard colonoscopy in the fecal occult blood test-based UK Bowel Cancer Screening Programme (E-cap study): a randomized trial

Endoscopy ◽  
2017 ◽  
Vol 49 (11) ◽  
pp. 1043-1050 ◽  
Author(s):  
Rupam Bhattacharyya ◽  
Fergus Chedgy ◽  
Kesavan Kandiah ◽  
Carole Fogg ◽  
Bernard Higgins ◽  
...  
Keyword(s):  
Detection Rate ◽  
Occult Blood ◽  
Fecal Occult Blood ◽  
Polyp Detection ◽  
Withdrawal Time ◽  
Fecal Occult ◽  
Adenoma Detection ◽  
Bowel Cancer Screening ◽  
The Mean ◽  
Standard Colonoscopy

Abstract Background and study aims Up to 25 % colorectal adenomas are missed during colonoscopy. The aim of this study was to investigate whether the endocuff could improve polyp detection in an organized bowel cancer screening program (BCSP). Patients and methods This parallel group, single-blinded, randomized controlled trial included patients with positive fecal occult blood test (FOBT) who were attending for BCSP colonoscopy. The primary outcome was the number of polyps per patient. Secondary outcomes included the number of adenomas per patient, adenoma and polyp detection rates, and withdrawal times. Results A total of 534 BCSP patients were randomized to endocuff-assisted or standard colonoscopy. The mean age was 67 years and the male to female ratio was 1.8:1. We detected no significant difference in the number of polyps per patient (standard 1.8, endocuff 1.6; P = 0.44), adenomas per patient (standard 1.4, endocuff 1.3; P = 0.54), polyp detection rate (standard 69.8 %, endocuff 70.3 %; P = 0.93), adenoma detection rate (standard 63.0 %, endocuff 60.9 %; P = 0.85), advanced adenoma detection rate (standard 18.5 %, endocuff 16.9 %; P = 0.81), and cancer detection rate (standard 5.7 %, endocuff 5.3 %; P = 0.85). The mean withdrawal time was significantly shorter among patients in the endocuff group compared with the standard colonoscopy group (16.9 vs. 19.5 minutes; P < 0.005). The endocuff had to be removed in 17/266 patients (6.4 %) because of inability to pass through the sigmoid colon. Conclusions This study did not find improved polyp or adenoma detection with endocuff-assisted colonoscopy in the FOBT-positive BCSP population. A shorter withdrawal time with endocuff may reflect improved views and stability provided by the endocuff.Trial registered at ClinicalTrials.gov (NCT02529007).

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