Second-generation distal attachment cuff for adenoma detection in screening colonoscopy: a randomized multicenter study.

BACKGROUND AND AIMS: Randomized studies have demonstrated that a distal attachment cap with rubber side arms, the Endocuff Vision (ECV; Olympus America, Center Valley, Pa, USA), increased colonoscopic adenoma detection rate (ADR) in various mixed patient collectives. This is the first study to evaluate its use in a primary colonoscopic screening program. METHODS: Patients over age 55 years undergoing screening colonoscopy in 9 German private offices in Berlin and Hamburg were randomized to either the study group using ECV or the control group using high-definition colonoscopies (standard of care). The main outcome parameter was ADR, whereas secondary outcomes were detection rates of all adenomas per colonoscopy (APCs), of adenoma subgroups, and of hyperplastic polyps. RESULTS: Of 1416 patients (mean age, 61.1 years; 51.8% women), with a median of 41 examinations per examiner (n = 23; interquartile range, 12-81), 700 were examined with ECV and 716 without. Adjusting for the effects of the colonoscopies, ADR was 39.5% (95% confidence interval [CI], 32.6%-46.3%) in the ECV group versus 32.2% (95% CI, 25.9%-38.6%) in the control group, which resulted in an increase of 7.2% (95% CI, 2.3%-12.2%; P = .004). The increase in ADR was mainly because of small polyps, with adjusted ADRs for adenomas <10 mm of 33.3% (95% CI, 26.5%-40.2%) for study patients versus 24.0% (95% CI, 18.2%-29.8%) for control patients (P < .001). APC was also significantly increased (.57 ECV vs .51 control subjects, P = .045). CONCLUSIONS: A distal attachment cap with side arms significantly increased the ADR in patients undergoing primary colonoscopic screening. Because of the correlation of ADR and interval cancer, its use should be encouraged, especially in this setting. (Clinical trial registration number: NCT03442738.).

Low Sensitivity of Simtomax Point of Care Test in Detection of Celiac Disease in a Prospective Multicenter Study.

BACKGROUND & AIMS: Point of care tests (POCTs) might be used to identify patients with undiagnosed celiac disease who require further evaluation. We performed a large multicenter study to determine the performance of a POCT for celiac disease and assessed celiac disease prevalence in endoscopy centers. METHODS: We performed a prospective study of 1055 patients (888 adults; median age, 48 yrs and 167 children; median age, 10 yrs) referred to 8 endoscopy centers in Germany, for various indications, from January 2016 through June 2017. Patients were tested for celiac disease using Simtomax, which detects immunoglobulin (Ig)A and IgG antibodies against deamidated gliadin peptides (DGP). Results were compared with findings from histologic analyses of duodenal biopsies (reference standard). The primary aim was to determine the accuracy of this POCT for the detection of celiac disease, to identify candidates for duodenal biopsy. A secondary aim was to determine the prevalence of celiac disease in adult and pediatric populations referred for outpatient endoscopic evaluation. RESULTS: The overall prevalence of celiac disease was 4.1%. The POCT identified individuals with celiac disease with 79% sensitivity (95% CI, 64%-89%) and 94% specificity (95% CI, 93%-96%). Positive and negative predictive values were 37% and 99%. When we analyzed the adult and pediatric populations separately, we found the test to identify adults with celiac disease (prevalence 1.2%) with 100% sensitivity and 95% specificity. In the pediatric population (celiac disease prevalence 19.6%), the test produced false-negative results for 9 cases; the test therefore identified children with celiac disease with 72% sensitivity (95% CI 53%-86%). Analyses of serologic data revealed significantly lower DGP titers in the false-negative vs the true-positive group. CONCLUSIONS: In a study of more than 1000 adults and children, we found the Simtomax POCT to detect celiac disease with lower overall levels of sensitivity than expected. Although the test identifies adults with celiac disease with high levels of sensitivity and specificity, the prevalence of celiac disease was as low as 1.2% among adults. The test's lack of sensitivity might be due to the low intensity of the POCT bands and was associated with low serum DGP titers. Study ID no: DRKS00012499.

Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II).

BACKGROUND AND AIMS: Sufficient bowel preparation is crucial for successful screening and surveillance colonoscopy. However, the rates of inadequate preparation are still high. We investigated the effects of reinforcing patient education and guidance by using the short message service (SMS). METHODS: In this prospective, endoscopist-blinded, multicenter study, standard instructions pertaining to split-dose preparation were provided in a verbal and written format to all patients during the initial appointment. Patients were randomly assigned (1:1) to a group that received reinforced education starting 4 days before the colonoscopy (SMS group) or to the control group which did not receive further education. The primary outcome was the percentage of insufficient preparation results (Boston Bowel Preparation Scale [BBPS] score <6). The secondary outcomes included quality of bowel preparation according to the BBPS, polyp and adenoma detection rates, and patients' perceived discomfort in the preparation procedure. RESULTS: The percentage of patients with insufficient bowel preparation was significantly lower in the SMS group (9%) than in the control group (19%) (P = .0013). The mean BBPS score was significantly higher in the SMS group (7.4 ± 0.1) than in the control group (6.5 ± 0.1) (P < .0001). Each colon segment had significantly higher BBPS scores in the SMS group. The adenoma detection rate and number of detected adenomas in the right segment of the colon were higher in the SMS group. SMS messages were accompanied by a lower level of discomfort during preparation (numeric rating scale) (5.2 SMS vs 5.8 controls) (P = .0042). CONCLUSIONS: Reinforced patient education by using SMS messages during the 4 days before colonoscopy increased bowel cleanliness, adenoma detection in the right segment of the colon, and reduced discomfort. (Clinical trial registration number: NCT02272036.).

Risk of Malignancy in Adenomas Detected During Screening Colonoscopy.

BACKGROUND & AIMS: A higher incidence of proximal interval cancers after colonoscopy has been reported in several follow-up studies. One possible explanation for this might be that proximally located adenomas have greater malignant potential. The aim of the present study was to assess the risk of malignancy in proximal versus distal adenomas in patients included in a large screening colonoscopy database; adenoma shape and the patients' age and sex distribution were also analyzed. METHODS: Data for 2007-2012 from the German National Screening Colonoscopy Registry, including 594,614 adenomas identified during 2,532,298 screening colonoscopies, were analyzed retrospectively. The main outcome measure was the rate of high-grade dysplasia (HGD) in adenomas, used as a surrogate marker for the risk of malignancy. Odds ratios (ORs) for the rate of HGD found in adenomas were analyzed in relation to patient- and adenoma-related factors using multivariate analysis. RESULTS: HGD histology was noted in 20,873 adenomas (3.5%). Proximal adenoma locations were not associated with a higher HGD rate. The most significant risk factor for HGD was adenoma size (OR 10.36 ≥1 cm vs <1 cm), followed by patient age (OR 1.26 and 1.46 for age groups 65-74 and 75-84 vs 55-64 years) and sex (OR 1.15 male vs female). In comparison with flat adenomas as a reference lesion, sessile lesions had a similar HGD rate (OR 1.02) and pedunculated adenomas had a higher rate (OR 1.23). All associations were statistically significant (P ≤ .05). CONCLUSIONS: In this large screening database, it was found that the rates of adenomas with HGD are similar in the proximal and distal colon. The presence of HGD as a risk marker alone does not explain higher rates of proximal interval colorectal cancer. We suggest that certain lesions (flat, serrated lesions) may be missed in the proximal colon and may acquire a more aggressive biology over time. A combination of endoscopy-related factors and biology may therefore account for higher rates of proximal versus distal interval colorectal cancer.

Effects of two instrument-generation changes on adenoma detection rate during screening colonoscopy: results from a prospective randomized comparative study.

BACKGROUND: Previous studies have shown that multiple colonoscope features have to be changed before an improvement in adenoma detection rate (ADR) becomes obvious, such as with changing from one instrument generation to the next but one. We wanted to evaluate whether such an effect can also be observed in a private-practice screening setting. METHODS: In a randomized study, we compared the latest generation colonoscopes from one company (Olympus Exera III, 190) with the next to last one (Olympus 165), including only patients presenting for screening colonoscopy. The primary outcome was ADR achieved with 190 colonoscopes (190-C) in comparison with 165 colonoscopes (165-C). RESULTS: 1221 patients (46.1 % men; mean age 62.2 years, standard deviation 6.6) were included (599 screened with the Olympus Exera III, 190). The ADR difference in favor of the 190-C instrument (32 % [95 % confidence interval (CI) 26 % to 39 %] vs. 28 % [95 %CI 22 % to 34 %] in the 165-C group) failed to reach statistical significance (P = 0.10); only the rate of small (< 5 mm) adenomas was significantly increased at 22.5 % (95 %CI 19 % to 26 %) vs. 15.6 % (95 %CI 13 % to 18 %; P = 0.002). Furthermore, significantly more adenomas were found in the 190-C group, with an adenoma rate (all adenomas/all patients) of 0.57 (95 %CI 0.53 to 0.61) vs. 0.47 (95 %CI 0.43 to 0.51; P < 0.001). CONCLUSIONS: This randomized comparative trial in a private-practice screening setting only partially confirmed the results of prior studies that, with multiple imaging improvements achieved over two instrument generations, an increase in overall adenoma number becomes measurable.

Endoscopic versus histological characterisation of polyps during screening colonoscopy.

BACKGROUND: As screening colonoscopy becomes more widespread, the costs for histopathological assessment of resected polyps are rising correspondingly. Reference centres have published highly accurate results for endoscopic polyp classification. Therefore, it has been proposed that, for smaller polyps, the differential diagnosis that guides follow-up recommendations could be based on endoscopy alone. OBJECTIVE: The aim was to prospectively assess whether the high accuracy for endoscopic polyp diagnosis as reported by reference centres can be reproduced in routine screening colonoscopy. DESIGN: Ten experienced private practice endoscopists had initial training in pit patterns. Then they assessed all polyps detected during 1069 screening colonoscopies. Patients (46% men; mean age 63 years) were randomly assigned to colonoscopy with conventional or latest generation HDTV instruments. The main outcome measure was diagnostic accuracy of in vivo polyp assessment (adenomatous vs hyperplastic). Secondary outcome measures were differences between endoscopes and reliability of image-based follow-up recommendations; a blinded post hoc analysis of polyp photographs was also performed. RESULTS: 675 polyps were assessed (461 adenomatous, 214 hyperplastic). Accuracy, sensitivity and specificity of in vivo diagnoses were 76.6%, 78.1% and 73.4%; size of adenomas and endoscope withdrawal time significantly influenced accuracy. Image-based recommendations for post-polypectomy surveillance were correct in only 69.5% of cases. Post hoc analysis of polyp photographs did not improve accuracy. CONCLUSIONS: In everyday practice, endoscopic classification of polyp type is not accurate enough to abandon histopathological assessment and use of latest generation colonoscopes does not improve this. Image-based surveillance recommendations after polypectomy would consequently not meet guideline requirements. TRIALREGNO: NCT01297712.

Factors determining the quality of screening colonoscopy: a prospective study on adenoma detection rates, from 12,134 examinations (Berlin colonoscopy project 3, BECOP-3).

BACKGROUND: Screening colonoscopy (SC) outcome quality is best determined by the adenoma detection rate (ADR). The substantial variability in the ADRs between endoscopists may reflect different skills, experience and/or equipment. OBJECTIVE: To analyse the potential factors that may influence ADR variance, including case volume. DESIGN: 12,134 consecutive SCs (mean age 64.5 years, 47% men) from 21 Berlin private-practice colonoscopists were prospectively studied during 18 months. The data were analysed using a two-level mixed linear model to adequately address the characteristics of patients and colonoscopists. The ADR was regressed after considering the following factors: sex, age, bowel cleanliness, NSAID intake, annual SC case volume, lifetime experience, instrument withdrawal times, instrument generations used, and the number of annual continuing medical education (CME) meetings attended by the physician. The case volume was also retrospectively analysed from the 2007 national SC registry data (312,903 colonoscopies and 1004 colonoscopists). RESULTS: The patient factors that correlated with the ADR were sex, age (p<0.001) and low quality of bowel preparation (p=0.005). The factors that were related to the colonoscopists were the number of CME meetings attended (p=0.012) and instrument generation (p=0.001); these factors accounted for approximately 40% of the interphysician variability. Within a narrow range (6-11 min), the withdrawal time was not correlated with the ADR. Annual screening case volume did not correlate with the ADR, and this finding was confirmed by the German registry data. CONCLUSIONS: The outcome quality of screening colonoscopies is mainly influenced by individual colonoscopist factors (ie, CME activities) and instrument quality. CLINICAL TRIAL REGISTRATION NUMBER: Clinical Trial Gov Registration number: NCT00860665.

Data quality of the German screening colonoscopy registry.

BACKGROUND AND STUDY AIMS: The German screening colonoscopy program is accompanied by a central registry that records the main outcome quality indicators, namely colonoscopy completion rate, adenoma detection rate (ADR), and complication rate. The aim of the present study was to assess the quality of these registry data by comparing them with data from a prospective quality assurance study based on a self-reporting audit and patient feedback of screening colonoscopy. PATIENTS AND METHODS: The completeness of registry information was analyzed by comparing it with prospective data gathered by audit and patient feedback in a previous quality assurance study (ClinicalTrials.gov registration number: NCT00860665) between October 2006 and March 2008. The main outcome parameters were colonoscopy completion rate, ADR, and complication rate. Complications were recorded in three steps in the audit study using case report forms (immediate and subsequent documentation by physicians [CRF-1 and CRF-2], and patient follow-up [CRF-3]), but were documented in the registry without differentiation. RESULTS: A total of 12 134 individuals (mean age 64.5 years; 47 % men) who underwent screening colonoscopy at 19 private practices in Berlin over the 18-month period were included in the audit study. Patient feedback was obtained for 90.1 %. A total of 12 150 cases had been recorded in the registry by the same private practices during the same period. Colonoscopy completion rate and ADR data were comparable in the audit study and registry (completion rate 98.2 % vs. 97.7 %; ADR 21.0 % vs. 20.5 %). However, compared with the registry data, the complication rate was 3.1-fold higher in the audit (0.46 % vs. 0.15 %; P < 0.001), and double (0.33 % vs. 0.15 %; P < 0.05) when patient feedback was not included. CONCLUSIONS: Of the screening colonoscopy quality parameters, colonoscopy completion rate and ADR, but not complication rates, were reliably documented in the German national screening colonoscopy registry. Data on complications need to be appropriately standardized and audited in order to be used for credentialing and benchmarking purposes.

[20 years of screening colonoscopy in Germany: current status, critical review and outlook]. / 20 Jahre Vorsorgekoloskopie in Deutschland: aktueller Stand, kritische Betrachtung und Ausblick.

20 years of colonoscopy for early cancer detection and screening in Germany. A success story - there is no longer any doubt about that, but a critical look should not be missing either.

Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate.

BACKGROUND & AIMS: Improvements to endoscopy imaging technologies might improve detection rates of colorectal cancer and patient outcomes. We compared the accuracy of the latest generation of endoscopes with older generation models in detection of colorectal adenomas. METHODS: We compared data from 2 prospective screening colonoscopy studies (the Berlin Colonoscopy Project 6); each study lasted approximately 6 months and included the same 6 colonoscopists, who worked in private practice. Participants in group 1 (n = 1256) were all examined by using the latest generation of wide-angle, high-definition colonoscopes that were manufactured by the same company. Individuals in group 2 (n = 1400) were examined by endoscopists who used routine equipment (a mixture of endoscopes from different companies; none of those used to examine group 1). The adenoma detection rate was calculated on the basis of the number of all adenomas/number of all patients. RESULTS: There were no differences in patient parameters or withdrawal time between groups (8.0 vs 8.2 minutes). The adenoma detection rate was significantly higher in group 1 (0.33) than in group 2 (0.27; P = .01); a greater number of patients with least 1 adenoma were identified in group 1 (22.1%) than in group 2 (18.2%; P = .01). A higher percentage of high-grade dysplastic adenomas were detected in group 1 (1.19%) than in group 2 (0.57%), but this difference was not statistically significant (P = .06). CONCLUSIONS: The latest generation of wide-angle, high-definition colonoscopes improves rates of adenoma detection by 22%, compared with mixed, older technology endoscopes used in routine private practice. These findings might affect definitions of quality control parameters for colonoscopy screening for colorectal cancer.

Narrow-band versus white-light high definition television endoscopic imaging for screening colonoscopy: a prospective randomized trial.

BACKGROUND & AIMS: Narrow-band imaging (NBI) has been implemented in gastrointestinal endoscopy to improve the contrast of endoluminal pathologic structures, one of the aims being to increase colonic adenoma detection. Previous studies from referral centers have yielded variable and conflicting results with regard to improvement in adenoma detection rates by using NBI. The present large randomized trial was designed to finally settle this issue. METHODS: In a prospective study performed exclusively in a multicenter private practice setting involving 6 examiners with substantial lifetime experience (>10,000 colonoscopies), 1256 patients (men:women, 47%:53%; mean age, 64.4 y) were randomized to HDTV screening colonoscopy with either NBI or white-light imaging on instrument withdrawal. The primary outcome measure was the adenoma detection rate (ie, number of adenomas/total number of patients). RESULTS: There was no difference between the 2 groups in terms of the general adenoma detection rate (0.32 vs 0.34), the total number of adenomas (200 vs 216), or in detection in subgroups of adenomas. This was despite a minimal, but significantly longer, withdrawal time in the NBI group (8.5 vs 7.9 min; P < .05). Only hyperplastic polyps were found more frequently in the NBI group (P = .03). CONCLUSIONS: This large randomized trial in a homogeneous private practice screening setting could not show any objective advantage of the NBI technique over white-light high definition television imaging in terms of improved adenoma detection rate. Contrast enhancement therefore likely will not contribute to a reduction in adenoma miss rates among experienced colonoscopists.

Live image processing does not increase adenoma detection rate during colonoscopy: a randomized comparison between FICE and conventional imaging (Berlin Colonoscopy Project 5, BECOP-5).

OBJECTIVES: Fujinon intelligent chromoendoscopy (FICE) is a post-processing imaging technique for increasing contrast of mucosa and mucosal lesions that might lead to improvement in colonic adenoma detection during colonoscopy. Previous studies on similar contrast-enhancing techniques as well as on dye staining have yielded variable and conflicting results. This large randomized trial was undertaken to determine whether FICE technology enhances adenoma detection rate (ADR). METHODS: In a prospective study performed in a multicenter private practice and hospital setting, involving 8 examiners with substantial lifetime experience (>10,000 colonoscopies each), 1,318 patients (men 46.7%, women 53.3%; mean age 59.05 years) were randomly assigned to colonoscopy with either FICE or white light imaging on instrument withdrawal. Of the colonoscopies, 68% were screening and 32% were diagnostic examinations. The primary outcome measure was the ADR (i.e., number of adenomas/total number of patients). RESULTS: There was no difference between the two groups in terms of general ADR (0.28 in both groups), the total number of adenomas (184 vs. 183), or detection of subgroups of adenomas. The rate of identification of hyperplastic polyps was also the same in both groups (127 vs. 121; P=0.67). The results were the same for both the screening and the diagnostic colonoscopy subgroups. Withdrawal time was the same in both groups (8.4 vs. 8.3 min, P=0.55). CONCLUSIONS: This large randomized trial could not show any objective advantage of the FICE technique over conventional high-resolution endoscopy in terms of improved ADR.