Charles Ménard

A MicroRNA-Based Test Improves Endoscopic Ultrasound–Guided Cytologic Diagnosis of Pancreatic Cancer

BACKGROUND & AIMS Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in combination with cytopathology is the optimal method for diagnosis and staging of pancreatic ductal adenocarcinoma (PDAC) and other pancreatic lesions. Its clinical utility, however, can be limited by high rates of indeterminate or false-negative results. We aimed to develop and validate a microRNA (miRNA)-based test to improve preoperative detection of PDAC. METHODS Levels of miRNAs were analyzed in a centralized clinical laboratory by relative quantitative polymerase chain reaction in 95 formalin-fixed paraffin-embedded specimens and 228 samples collected by EUS-FNA during routine evaluations of patients with solid pancreatic masses at 4 institutions in the United States, 1 in Canada, and 1 in Poland. RESULTS We developed a 5-miRNA expression classifier, consisting of MIR24, MIR130B, MIR135B, MIR148A, and MIR196, that could identify PDAC in well-characterized, formalin-fixed, paraffin-embedded specimens. Detection of PDAC in EUS-FNA samples increased from 78.8% by cytology analysis alone (95% confidence interval, 72.2%-84.5%) to 90.8% when combined with miRNA analysis (95% confidence interval, 85.6%-94.5%). The miRNA classifier correctly identified 22 additional true PDAC cases among 39 samples initially classified as benign, indeterminate, or nondiagnostic by cytology. Cytology and miRNA test results each were associated significantly with PDAC (P < .001), with positive predictive values greater than 99% (95% confidence interval, 96%-100%). CONCLUSIONS We developed and validated a 5-miRNA classifier that can accurately predict which preoperative pancreatic EUS-FNA specimens contain PDAC. This test might aid in the diagnosis of pancreatic cancer by reducing the number of FNAs without a definitive adenocarcinoma diagnosis, thereby reducing the number of repeat EUS-FNA procedures.

Validating bowel preparation scales

Background and study aim  Few scales assessing bowel preparation quality have been validated, and direct between-scale comparisons remain scarce. The aim of the study was to compare inter- and intra-rater reliability, predictive abilities for clinical outcomes, and ease of use for each scale. Methods  Colonoscopy video recordings highlighting five colonic segments after washing were viewed independently by three physicians, and cleanliness was evaluated using the Boston Bowel Preparation Scale (BBPS), the Chicago Bowel Preparation Scale (CBPS), and the Harefield Cleansing Scale (HCS) in randomized order. Kappa or intraclass correlations quantified intra- and inter-rater reliability. Ease of use was evaluated (1 – 10 scale, 1 = easy), as were associations between scores, adenoma detection, and adequacy of preparation to exclude lesions ≥ 5 mm. Results  Among 83 colonoscopy videos, indications included screening or surveillance in 72.3 %. Mean (± SD) scores of the respective three raters were 5.17 ± 1.57, 6.49 ± 1.48, and 5.12 ± 1.21 for BBPS, and 23.73 ± 6.01, 28.39 ± 5.47, and 24.75 ± 5.83 for CBPS, while successful HCS scores (grade A or B) were given for 76 %, 89 %, and 63 % of examinations. Intra-rater reliability ranges were 0.88 – 1.00, 0.83 – 1.00, and 0.62 – 1.00 for BBPS, CBPS, and HCS, respectively. Similarly, inter-rater reliability ranges were 0.50 – 0.79, 0.64 – 0.83, and 0.28 – 0.52, respectively. Sources of disagreement included varying rater strictness, which was possibly most marked for preparations rated as intermediate. Overall, associations between preparation scores and adenoma detection lacked statistical significance. Conclusion  The BBPS and CBPS showed the best inter- and intra-rater reliability, and the BBPS was considered the easiest to use. Further studies are needed to determine an optimal adequacy threshold for these scales, with the goal of predicting clinical outcomes and determining the appropriate interval to the next colonoscopy.

Implementation of a checklist before colonoscopy: a quality improvement initiative

BACKGROUND AND STUDY AIMS Checklists can prevent errors and have a positive impact on patient morbidity and mortality in different surgical settings, and possibly also in gastrointestinal endoscopy. The aims of this study were to reinforce commitment in safety culture and better communication among team members in endoscopy, and to prove the feasibility of successful checklist adoption before colonoscopy. PATIENTS AND METHODS The study involved a pre - post quality improvement intervention involving all consecutive patients undergoing a colonoscopy at a single academic endoscopy unit. The first part of the study was a retrospective audit, carried out over a 3-month period (July to September 2016). A checklist developed through a formal validation process was implemented during the intervention period (October to December 2016). Primary outcomes were changes in patient and team satisfaction after the quality improvement intervention, using validated 5-point scale questionnaires. Secondary outcomes included successful procedure completion rates and safety outcomes. RESULTS During the baseline and comparative intervention period, 1317 and 1141 colonoscopies, respectively, were performed. Overall, checklists were fully completed by nurses and physicians for 791 patients (69.3 %). Mean overall patient satisfaction was high at baseline and did not differ following the quality improvement intervention (4.66 vs. 4.63; P  = 0.5). Perception of team communication and teamwork was improved after checklist implementation. Comparative analyses of per-procedure and safety outcomes did not differ between the pre- and post-checklist implementation. CONCLUSION Adoption of an endoscopy checklist before colonoscopy is feasible, and significantly increases perception of team communication and teamwork. Additional studies are needed to assess the generalizability of these results to complex endoscopic procedures and to characterize any improvement in patient safety outcomes.

Systematic review and meta-analysis of colon cleansing preparations in patients with inflammatory bowel disease

AIM To performed a systematic review and meta-analysis to determine any possible differences in terms of effectiveness, safety and tolerability between existing colon-cleansing products in patients with inflammatory bowel disease. METHODS Systematic searches were performed (January 1980-September 2016) using MEDLINE, EMBASE, Scopus, CENTRAL and ISI Web of knowledge for randomized trials assessing preparations with or without adjuvants, given in split and non-split dosing, and in high (> 3 L) or low-volume (2 L or less) regimens. Bowel cleansing quality was the primary outcome. Secondary outcomes included patient willingness-to-repeat the procedure and side effects/complications. RESULTS Out of 439 citations, 4 trials fulfilled our inclusion criteria (n = 449 patients). One trial assessed the impact of adding simethicone to polyethylene glycol (PEG) 4 L with no effect on bowel cleansing quality, but a better tolerance. Another trial compared senna to castor oil, again without any differences in term of bowel cleansing. Two trials compared the efficacy of PEG high-volume vs PEG low-volume associated to an adjuvant in split-dose regimens: PEG low-dose efficacy was not different to PEG high-dose; OR = 0.84 (0.37-1.92). A higher proportion of patients were willing to repeat low-volume preparations vs high-volume; OR = 5.11 (1.31-20.0). CONCLUSION In inflammatory bowel disease population, PEG low-volume regimen seems not inferior to PEG high-volume to clean the colon, and yields improved willingness-to-repeat. Further additional research is urgently required to compare contemporary products in this population.