A randomized controlled trial evaluating general endotracheal anesthesia versus monitored anesthesia care and the incidence of sedation-related adverse events during ERCP in high-risk patients.

BACKGROUND AND AIMS: ERCP is a complex procedure often performed in patients at high risk for sedation-related adverse events (SRAEs). However, there is no current standard of care with regard to mode of sedation and airway management during ERCP. The aim of this study was to assess the safety of general endotracheal anesthesia (GEA) versus propofol-based monitored anesthesia care (MAC) without endotracheal intubation in patients undergoing ERCP at high risk for SRAEs. METHODS: Consecutive patients undergoing ERCP at high risk for SRAEs at a single center were invited to participate in this randomized controlled trial comparing GEA and MAC. Inclusion criteria were STOP-BANG score ≥3, abdominal ascites, body mass index ≥35, chronic lung disease, American Society of Anesthesiologists class >3, Mallampati class 4 airway, and moderate to heavy alcohol use. Exclusion criteria were preceding EUS, emergent ERCP, tracheostomy, unstable airway, gastric outlet obstruction or delayed gastric emptying, and altered foregut anatomy. The primary endpoint was composite incidence of SRAEs: hypoxemia, use of airway maneuvers, hypotension requiring vasopressors, sedation-related procedure interruption, cardiac arrhythmia, and respiratory failure. Secondary outcomes included procedure duration, cannulation success, in-room time, and immediate adverse events. RESULTS: Two hundred patients (mean age, 61.1 ± 13.6 years; 36.5% women) were randomly assigned to GEA (n = 101) or MAC (n = 99) groups. Composite SRAEs were significantly higher in the MAC group compared with the GEA group (51.5% vs 9.9%, P < .001). This was primarily driven by the frequent need for airway maneuvers in the MAC group. Additionally, ERCP was interrupted in 10.1% of patients in the MAC group to convert to GEA because of respiratory instability refractory to airway maneuvers (n = 8) or significant retained gastric contents (n = 2). There were no statistically significant differences in cannulation, in-room, procedure, or fluoroscopy times between the 2 groups. All patients undergoing GEA were successfully extubated in the procedure room at completion of ERCP, and Aldrete scores in recovery did not differ between the 2 groups. There were no immediate adverse events. CONCLUSION: In patients at high risk for SRAEs undergoing ERCP, sedation with GEA is associated with a significantly lower incidence of SRAEs, without impacting procedure duration, success, recovery, or in-room time. These data suggest that GEA should be used for ERCP in patients at high risk for SRAEs (Clinical trial registration number: NCT02850887.).

The Diagnostic Yield of Malignancy Comparing Cytology, FISH, and Molecular Analysis of Cell Free Cytology Brush Supernatant in Patients With Biliary Strictures Undergoing Endoscopic Retrograde Cholangiography (ERC): A Prospective Study.

BACKGROUND: Routine cytology of biliary stricture brushings obtained during endoscopic retrograde cholangiopancreatography (ERCP) has suboptimal sensitivity for malignancy. We compared the individual and combined ability of cytology, fluorescence in situ hybridization (FISH) analysis and PCR-based mutation profiling (MP) to detect malignancy in standard biliary brushings. METHODS: We performed a prospective study of patients undergoing ERCP using histology or 1 year follow-up to determine patient outcomes. MP was performed on free-DNA from biliary brushing specimens using normally discarded supernatant fluid. MP examined KRAS point mutations and tumor suppressor gene associated loss of heterozygosity mutations at 10 genomic loci. FISH examined chromosome specific gains or losses. RESULTS: A total of 101 patients were included in final analysis and 69% had malignancy. Cytology had 26% sensitivity and 100% specificity for malignancy. Using either FISH or MP in combination with cytology increased sensitivity to 44% and 56%, respectively. The combination of all 3 tests (cytology, FISH, and MP) had the highest sensitivity for malignancy (66%). There was no difference in the specificity of cytology, FISH or MP testing when examined alone or in combination. MP improved diagnostic yield of each procedure from 22% to 100%; FISH improved yield to 90%. MP detected 21 malignancies beyond that identified by cytology; FISH detected an additional 13. The combination of FISH and MP testing detected an additional 28 malignancies. CONCLUSIONS: Both MP and FISH are complimentary molecular tests that can significantly increase detection of biliary malignancies when used in combination with routine cytology of standard biliary brush specimens.

Variation in learning curves and competence for ERCP among advanced endoscopy trainees by using cumulative sum analysis.

BACKGROUND AND AIMS: There are limited data on learning curves and competence in ERCP. By using a standardized data collection tool, we aimed to prospectively define learning curves and measure competence among advanced endoscopy trainees (AETs) by using cumulative sum (CUSUM) analysis. METHODS: AETs were evaluated by attending endoscopists starting with the 26th hands-on ERCP examination and then every ERCP examination during the 12-month training period. A standardized ERCP competency assessment tool (using a 4-point scoring system) was used to grade the examination. CUSUM analysis was applied to produce learning curves for individual technical and cognitive components of ERCP performance (success defined as a score of 1, acceptable and unacceptable failures [p1] of 10% and 20%, respectively). Sensitivity analyses varying p1 and by using a less-stringent definition of success were performed. RESULTS: Five AETs were included with a total of 1049 graded ERCPs (mean ± SD, 209.8 ± 91.6/AET). The majority of cases were performed for a biliary indication (80%). The overall and native papilla allowed cannulation times were 3.1 ± 3.6 and 5.7 ± 4, respectively. Overall learning curves demonstrated substantial variability for individual technical and cognitive endpoints. Although nearly all AETs achieved competence in overall cannulation, none achieved competence for cannulation in cases with a native papilla. Sensitivity analyses increased the proportion of AETs who achieved competence. CONCLUSION: This study demonstrates that there is substantial variability in ERCP learning curves among AETs. A specific case volume does not ensure competence, especially for native papilla cannulation.

Variation in Aptitude of Trainees in Endoscopic Ultrasonography, Based on Cumulative Sum Analysis.

BACKGROUND & AIMS: Studies have reported substantial variation in the competency of advanced endoscopy trainees, indicating a need for more supervised training in endoscopic ultrasound (EUS). We used a standardized, validated, data collection tool to evaluate learning curves and measure competency in EUS among trainees at multiple centers. METHODS: In a prospective study performed at 15 centers, 17 trainees with no prior EUS experience were evaluated by experienced attending endosonographers at the 25th and then every 10th upper EUS examination, over a 12-month training period. A standardized data collection form was used (using a 5-point scoring system) to grade the EUS examination. Cumulative sum analysis was applied to produce a learning curve for each trainee; it tracked the overall performance based on median scores at different stations and also at each station. Competency was defined by a median score of 1, with acceptable and unacceptable failure rates of 10% and 20%, respectively. RESULTS: Twelve trainees were included in the final analysis. Each of the trainees performed 265 to 540 EUS examinations (total, 4257 examinations). There was a large amount of variation in their learning curves: 2 trainees crossed the threshold for acceptable performance (at cases 225 and 245), 2 trainees had a trend toward acceptable performance (after 289 and 355 cases) but required continued observation, and 8 trainees needed additional training and observation. Similar results were observed at individual stations. CONCLUSIONS: A specific case load does not ensure competency in EUS; 225 cases should be considered the minimum caseload for training because we found that no trainee achieved competency before this point. Ongoing training should be provided for trainees until competency is confirmed using objective measures.

The clinical impact of immediate on-site cytopathology evaluation during endoscopic ultrasound-guided fine needle aspiration of pancreatic masses: a prospective multicenter randomized controlled trial.

OBJECTIVES: Observational data on the impact of on-site cytopathology evaluation (OCE) during endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) of pancreatic masses have reported conflicting results. We aimed to compare the diagnostic yield of malignancy and proportion of inadequate specimens between patients undergoing EUS-FNA of pancreatic masses with and without OCE. METHODS: In this multicenter randomized controlled trial, consecutive patients with solid pancreatic mass underwent randomization for EUS-FNA with or without OCE. The number of FNA passes in the OCE+ arm was dictated by the on-site cytopathologist, whereas seven passes were performed in OCE- arm. EUS-FNA protocol was standardized, and slides were reviewed by cytopathologists using standardized criteria for cytologic characteristics and diagnosis. RESULTS: A total of 241 patients (121 OCE+, 120 OCE-) were included. There was no difference between the two groups in diagnostic yield of malignancy (OCE+ 75.2% vs. OCE- 71.6%, P=0.45) and proportion of inadequate specimens (9.8 vs. 13.3%, P=0.31). Procedures in OCE+ group required fewer EUS-FNA passes (median, OCE+ 4 vs. OCE- 7, P<0.0001). There was no significant difference between the two groups with regard to overall procedure time, adverse events, number of repeat procedures, costs (based on baseline cost-minimization analysis), and accuracy (using predefined criteria for final diagnosis of malignancy). There was no difference between the two groups with respect to cytologic characteristics of cellularity, bloodiness, number of cells/slide, and contamination. CONCLUSIONS: Results of this study demonstrated no significant difference in the diagnostic yield of malignancy, proportion of inadequate specimens, and accuracy in patients with pancreatic mass undergoing EUS-FNA with or without OCE.

Compliance with surveillance recommendations for foregut subepithelial tumors is poor: results of a prospective multicenter study.

BACKGROUND: American Gastroenterological Association guidelines recommend performing EUS to characterize subepithelial lesions (SELs) discovered on upper endoscopy (EGD), followed by surveillance if no high-risk features are identified. However, limited data are available on the impact of and compliance with surveillance recommendations. OBJECTIVE: To determine the natural history of SELs<30 mm in size evaluated by EUS and to determine the degree of patient compliance with surveillance recommendations. DESIGN: Prospective registry. SETTING: Two tertiary centers. PATIENTS: We studied 187 consecutive adult patients referred for EUS evaluation of foregut SELs. MAIN OUTCOME MEASUREMENTS: Proportion of patients in whom SELs change in size or echo-features and compliance with follow-up recommendations. RESULTS: Surveillance was recommended in 65 patients with hypoechoic SELs (44.6% women, age 59.5±13.2 years); of these, 29 (44.6%) underwent surveillance EUS as recommended and were followed for a median of 30 months (range, 12-105). During follow-up, 16 SELs (25%) increased in size, with a mean increase of 3.4±3.9 mm (range, 1-15). No changes in echo-texture of the SELs were observed. One patient was referred to surgery during follow-up (because of SEL growth>30 mm). LIMITATIONS: Short follow-up duration; compliance was a secondary aim. CONCLUSIONS: During a median follow-up of 30 months, growth in size was observed in 25% of small foregut SELs. However, change in size was minimal, and only 1 patient was referred for surgery based on surveillance EUS findings. Compliance with surveillance recommendations is poor, with fewer than 50% of patients undergoing surveillance EUS as recommended.

Resect and discard approach to colon polyps: real-world applicability among academic and community gastroenterologists.

BACKGROUND: "Resect and discard" (RD) is a new paradigm for management of diminutive polyps. AIM: To compare concordance of surveillance interval recommendations and diagnostic performance between RD and standard of care in a hospital outpatient department with both academic and community gastroenterologists. METHODS: Prospective, observational study conducted at a single outpatient endoscopy center over 12 months. Patients with diminutive polyps on screening or surveillance colonoscopy were included. Histology predictions for all diminutive polyps (≤5 mm) were made based on endoscopic imaging. Concordance of recommended surveillance intervals and diagnostic performance of histology predictions were compared to histopathological review. RESULTS: A total of 606 diminutive polyps were found in 315 patients (mean age 62.4 years, 49 % female). Histological prediction was made in 95.7 % of polyps (97.4 % of patients), with high confidence in 74.3 %. The concordance for surveillance intervals was 82.1 % compared to histopathological review and was similar between community and academic gastroenterologists (80.2 vs. 76.3 %, p = 0.38). Overall, sensitivity, specificity, and accuracy of histological predictions made with high confidence were 0.81, 0.36, and 77.1 %. Predictions made with narrow-band imaging (NBI) had lower accuracy (73.9 % with NBI vs. 82.5 % with high-definition white light (HWDL) only, p = 0.017) as well as lower prediction confidence (score of 7.6 with NBI vs. 8.6 with HDWL only, p < 0.001). CONCLUSIONS: Our surveillance interval concordance was below the 90 % threshold deemed acceptable by the ASGE Preservation and Incorporation of Valuable Endoscopic Innovations statement. Diagnostic performance using optical imaging to predict histology was equal between community and academic endoscopists.

Learning curves for EUS by using cumulative sum analysis: implications for American Society for Gastrointestinal Endoscopy recommendations for training.

BACKGROUND: American Society for Gastrointestinal Endsocopy (ASGE) guidelines for assessing minimal competence in EUS are based on expert opinion and retrospective studies. OBJECTIVE: To prospectively define learning curves in EUS among advanced endoscopy trainees (AETs). DESIGN: Prospective trial. SETTING: Three tertiary-care referral centers. PATIENTS: AETs with no prior EUS experience. INTERVENTION: AETs were evaluated by attending endosonographers at intervals of 10 EUS examinations (beginning at the 25th examination) during a 12-month training period. A standardized data collection form was used to grade examination of EUS anatomic stations and, when applicable, lesion of interest, accurate uTNM staging, wall layer origin of subepithelial lesions, and technical success with FNA. MAIN OUTCOME MEASUREMENTS: Cumulative sum analysis was applied to assess competency and produce a learning curve for each trainee for overall performance and for each anatomic station. Acceptable and unacceptable failure rates of 10% and 20%, respectively, were used. RESULTS: Five AETs were included, with a total of 1412 EUS examinations (AET1-225, T2-175, T3-402, T4-315, T5-295). Two AETs crossed the threshold for acceptable performance at cases number 255 and 295, two AETs showed a trend toward acceptable performance after 225 and 196 cases but needed ongoing training, and 1 AET demonstrated the need for ongoing training after 402 cases. Similar variable results were noted for individual stations. LIMITATIONS: Results from this study may not be generalizable to other centers' AETs. CONCLUSION: We observed substantial variability in achieving competency and a consistent need for more supervision in all AETs than current recommendations (150 cases). Future studies should focus on standardization of trainee performance, definition of competency, and widespread applicability of AET evaluation.

Long-term outcomes after single-balloon enteroscopy in patients with obscure gastrointestinal bleeding.

BACKGROUND: Limited data exists on the long-term outcomes of patients with obscure gastrointestinal bleeding (OGIB) following single-balloon enteroscopy (SBE). AIM: To examine the long-term outcomes of patients undergoing SBE for OGIB. METHODS: Consecutive patients undergoing SBE for OGIB at a tertiary care center between 2008 and 2010 were retrospectively identified. Clinical data and SBE findings were extracted from the medical record. Recurrence of OGIB during follow-up through 2012 was assessed by a combination of chart review and telephone interviews. RESULTS: One hundred and forty-seven patients were included in the study. The overall diagnostic yield of SBE was 64.6% (95/147 patients). Findings of SBE included vascular lesions (VLs, 53.7%), small bowel neoplasm (2.7%), inflammatory lesions (4.8%), and normal SBE (35.4%). One hundred and ten patients (56.4% female, mean age 70.6±11.3 years) were followed for an average 23.9 months after initial SBE. During follow-up, OGIB recurred in 39.5% of patients in whom a source of OGIB was identified on SBE and 55.9% of patients with normal findings on SBE. OGIB recurred in 47.6% of patients in whom small bowel VLs were treated endoscopically. None of the 13 patients in whom a non-VL lesion was identified as the source of bleeding on SBE experienced recurrent bleeding (p=0.019). CONCLUSIONS: SBE is a safe and valuable method for managing patients with OGIB. More than 50% of patients experienced no recurrent bleeding during 2 years of follow-up after SBE. The long-term management of OGIB due to small bowel VLs remains challenging.

Diagnostic yield of malignancy during EUS-guided FNA of solid lesions with and without a stylet: a prospective, single blind, randomized, controlled trial.

BACKGROUND: Use of a stylet during EUS-guided FNA (EUS-FNA) is believed to improve the quality and diagnostic yield of specimens. OBJECTIVE: To compare samples obtained by EUS-FNA with (S+) and without (S-) a stylet for diagnostic yield of malignancy and cytological characteristics. DESIGN: Randomized, controlled trial. SETTING: Tertiary referral center. PATIENTS: Consecutive patients referred for EUS-FNA of solid lesions. INTERVENTION: EUS-FNA; the number of passes was determined by lesion site (6 pancreas/others and 4 lymph nodes). MAIN OUTCOME MEASUREMENTS: Diagnostic yield of malignancy and degree of cellularity, specimen adequacy, contamination, and amount of blood. RESULTS: One hundred patients were prospectively enrolled in this randomized, controlled trial and the sites of EUS-FNA were the pancreas, 58; lymph node, 25; and other, 17. The overall diagnosis was malignancy in 56, benign in 30, suspicious/atypical in 7, and inadequate specimen in 7 lesions. There were 550 passes made (275 with a stylet and 275 without a stylet). Interim analysis demonstrated no difference in the diagnostic yield of malignancy (94 passes with a stylet [34.2%] vs 110 without a stylet [40%], P = .2) and in the proportion of inadequate specimens (57 with a stylet [20.7%] vs 64 without a stylet [23.3%], P = .2). There was no difference with regard to cellularity (P = .83), contamination (P = .31), number of cells (P = .25), and amount of blood (P = .6). Similar results were noted in a subgroup analysis based on lesion site. Applying the rules of futility, the study was terminated. LIMITATIONS: Subjectivity in cytopathologists' assessment, endosonographer not blinded. CONCLUSIONS: There was no difference in the diagnostic yield of malignancy or proportion of inadequate specimens between passes with and without a stylet. These results suggest that the use of a stylet does not confer any advantage during EUS-FNA.