Brian S. Lim

A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation

BACKGROUND Sedation for colonoscopy discomfort imposes a recovery-time burden on patients. The water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without sedation. On-site and at-home recovery times were not reported. OBJECTIVE To confirm the beneficial effect of the water method and document the patient recovery-time burden. DESIGN Randomized, controlled trial, with single-blinded, intent-to-treat analysis. SETTING Veterans Affairs outpatient endoscopy unit. PATIENTS This study involved veterans accepting on-demand sedation for screening and surveillance colonoscopy. INTERVENTION Air versus water method for colonoscope insertion. MAIN OUTCOME MEASUREMENTS Proportion of patients completing colonoscopy without sedation, cecal intubation rate, medication requirement, maximum discomfort (0 = none, 10 = severe), procedure-related and patient-related outcomes. RESULTS One hundred veterans were randomized to the air (n = 50) or water (n = 50) method. The proportions of patients who could complete colonoscopy without sedation in the water group (78%) and the air group (54%) were significantly different (P = .011, Fisher exact test), but the cecal intubation rate was similar (100% in both groups). Secondary analysis (data as Mean [SD]) shows that the water method produced a reduction in medication requirement: fentanyl, 12.5 (26.8) μg versus 24.0 (30.7) μg; midazolam, 0.5 (1.1) mg versus 0.94 (1.20) mg; maximum discomfort, 2.3 (1.7) versus 4.9 (2.0); recovery time on site, 8.4 (6.8) versus 12.3 (9.4) minutes; and recovery time at home, 4.5 (9.2) versus 10.9 (14.0) hours (P = .049; P = .06; P = .0012; P = .0199; and P = .0048, respectively, t test). LIMITATIONS Single Veterans Affairs site, predominantly male population, unblinded examiners. CONCLUSION This randomized, controlled trial confirms the reported beneficial effects of the water method. The combination of the water method with on-demand sedation minimizes the patient recovery-time burden. ( CLINICAL TRIAL REGISTRATION NUMBER NCT00920751.).

Effect of ERCP mechanical simulator (EMS) practice on trainees' ERCP performance in the early learning period: US multicenter randomized controlled trial.

OBJECTIVES:The impact of endoscopic retrograde cholangiopancreatography (ERCP) mechanical simulator (EMS) practice on trainee clinical performance is unknown. The hypothesis that trainees with EMS practice (study group (SG)) have improved clinical outcomes compared with those without such practice (control group (CG)) is tested.METHODS:This was a randomized controlled trial involving six US academic centers. Sixteen trainees were randomized after ERCP didactic teaching. SG (n=8) participated in two sessions of EMS practice on selective cannulation; CG (n=8) did not undergo EMS practice. All participants’ clinical performances were monitored in the subsequent 16 weeks. Intervention effects were assessed in multivariable regression models using generalizing estimating equations (GEE) to account for cluster randomization of trainees. The primary outcome was successful biliary cannulation, and secondary outcomes were cannulation time and competency score.RESULTS:Cannulation success rate was 47.1% for CG and 69.6% for SG. SG had higher odds of successful cannulation (adjusted odds ratio=3.01, P=0.021). SG trainees achieved faster cannulation time (min) (4.7±4.2 vs. 10.3±14.1, P<0.001). Trainee competency scores given by supervising physicians were comparable confirming adequate blinding of the trainers. Limitations included short observation period, small number of ERCPs performed by individual trainees, and variation in the number of ERCPs between trainees.CONCLUSIONS:In a prospective multicenter randomized controlled trial during early training, a significantly higher proportion of the biliary cannulations performed by trainees with EMS practice were successful and with faster cannulation time compared with those performed by trainees without such practice. The results provide objective evidence to support the continued evaluation of EMS practice to augment clinical training.

Retrospective Application of 2012 Revised International Consensus Guidelines to Suspected Mucinous-Type Pancreatic Cysts Managed in the Sendai Era

1.1.Background:Pancreatic cystic lesions (PCL) are a common clinical problem. International consensus guidelines were published in 2006 and revised in 2012 to assist clinicians in the diagnosis and management. 1.2.Methods:2012 international consensus guidelines (ICG-2012) were retrospectively applied to PCLs originally managed with ICG-2006. PCLs diagnosed in 2008-2012 (Sendai era) were included if: (1) lesions were suspected to be BD-IPMN (branch duct intraductal papillary mucinous neoplasm) prior to surgery with carcinoembryonic antigen < 192, (2) required resection based on ICG-2006, (3) final diagnosis verified by histopathology. Performance of ICG-2012 was tested with indications for resection defined as carcinoma and pre-malignant lesions such as pancreatic intraepithelial neoplasia (PanIN). 1.3.Results:15 PCLs met the inclusion criteria. Applying ICG-2012, following were the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy, expressed as % (N/C = not calculable), for each of the criteria featured in the proposed algorithm. High-risk stigmata: enhancing solid component within cyst (50, 92, 92, 50, 87), main pancreatic duct (MPD) ≥ 10mm (0, 100, 87, N/C, 87). Clinical worrisome features: pancreatitis (0, 85, 85, 0, 73). Worrisome features on cross sectional imaging: cyst ≥ 3cm (0, 38, 71, 0, 33), thickened/enhancing cyst walls (0, 85, 85, 0, 73), MPD 5-9 mm (33, 100, 87, 100, 88), non-enhancing mural nodule (0, 92, 86, 0, 80), abrupt change in PD caliber with distal atrophy (100, 100, 100, 100, 100). EUS (endoscopic ultrasound) features: definite mural nodule (100, 62, 100, 29, 67), MPD suspicious for involvement (0, 100, 87, N/C, 87), cytology (0, 100, 92, N/C, 92). Channeling PCLs through the ICG-2012 algorithm, 4 lesions [1 adenocarcinoma and 3 MCNs (if the resection indication was expanded to include MCNs)] that met resection criteria with ICG-2006 would not be resected utilizing ICG-2012. Conclusion:Feature in ICG-2012 algorithm that predicted carcinoma/pre-malignant lesions with highest accuracy was abrupt change in PD caliber with distal atrophy on cross sectional imaging. Cyst details such as mural nodules may be missed on cross sectional imaging but detected on EUS, which suggests a possible need for at least one EUS in PCL size of 1-2 cm