Threshold evaluation for optimal number of endoscopic treatment sessions to achieve complete eradication of Barrett's metaplasia.

BACKGROUND: Endoscopic eradication therapy (EET) is the standard of care for Barrett's esophagus (BE)-associated neoplasia. Previous data suggest the mean number of EET sessions required to achieve complete eradication of intestinal metaplasia (CE-IM) is 3. This study aimed to define the threshold of EET sessions required to achieve CE-IM. METHODS: The TREAT-BE Consortium is a multicenter outcomes cohort including prospectively enrolled patients with BE undergoing EET. All patients achieving CE-IM were included. Demographic, endoscopic, and histologic data were recorded at treatment onset along with treatment details and surveillance data. Kaplan-Meier analysis was performed to define a threshold of EET sessions, with 95 %CI, required to achieve CE-IM. A secondary analysis examined predictors of incomplete response to EET using multiple logistic regression and recurrence rates. RESULTS: 623 patients (mean age 65.2 [SD 11.6], 79.6 % male, 86.5 % Caucasian) achieved CE-IM in a mean of 2.9 (SD 1.7) EET sessions (median 2) and a median total observation period of 2.7 years (interquartile range 1.4-5.0). After three sessions, 73 % of patients achieved CE-IM (95 %CI 70 %-77 %). Age (odds ratio [OR] 1.25, 95 %CI 1.05-1.50) and length of BE (OR 1.24, 95 %CI 1.17-1.31) were significant predictors of incomplete response. CONCLUSION: The current study found that a threshold of three EET sessions would achieve CE-IM in the majority of patients. Alternative therapies and further diagnostic testing should be considered for patients who do not have significant response to EET after three sessions.

Combination of ERCP-Based Modalities Increases Diagnostic Yield for Biliary Strictures.

BACKGROUND: Biliary stricture evaluation with brush cytology and intraductal forceps biopsy carries a low sensitivity, but the combination of newer modalities may improve sensitivity. AIM: To determine whether the addition of advanced modalities increases diagnostic yield of ERCP-based sampling. METHODS: This single-center retrospective study evaluates patients with biliary strictures sampled using brush cytology. Operating characteristics were calculated for individual and combinations of modalities including cholangioscopy, fluoroscopy- and cholangioscopy-directed intraductal biopsy, fluorescence in situ hybridization (FISH), and confocal laser endomicroscopy. Analyses under Standard Criteria (SC) included malignant results as "positive" and Expanded Criteria (EC) included "suspicious" and "high-grade dysplasia" results as "positive." RESULTS: A total of 614 patients were included, and 354 (57.8%) received brush cytology alone, which had a sensitivity of 38.5% (SC) to 40.3% (EC) and a specificity of 97.8% (EC) to 99.3% (SC). Combining brush cytology with fluoroscopy-guided biopsy (n = 259, 42.2%) had a sensitivity of 62.5% (SC) to 67.9% (EC) and specificity of 90.2% (EC) to 96.7% (SC). Adding FISH to brush cytology had a sensitivity of 84.2% (SC) to 87.5% (EC) and specificity of 54.1% (SC and EC), while cholangioscopy visualization addition resulted in a sensitivity of 80.4% (SC) to 92.2% (EC) and specificity of 67.3% (EC) to 89.1% (SC). There were no significant differences in sensitivity and specificity using SC and EC. CONCLUSIONS: Brush cytology has a low sensitivity, but the addition of other modalities increases sensitivity. There was no difference in specificity between the SC and the EC, supporting the inclusion of "suspicious" impressions with malignant results at our center.

Endoscopic Ultrasound Placement of Preloaded Fiducial Markers Shortens Procedure Time Compared to Back-Loaded Markers.

BACKGROUND & AIMS: Fiducial markers are inert radiopaque gold or carbon markers implanted in or near pancreatic tumor to demarcate areas for image-guided radiation therapy. Endoscopic ultrasound (EUS) pre-loaded fiducial needles (PLNs) have been developed to circumvent technical issues associated with traditional back-loaded fiducials (BLNs). We performed a randomized controlled trial to compare procedure times in patients with pancreatic adenocarcinoma undergoing EUS-guided placement of BLNs vs PLNs. METHODS: In a prospective study, 44 patients with pancreatic adenocarcinoma referred for fiducial marker placement at 2 tertiary care centers were assigned to groups that received PLNs (n = 22) or BLNs (n = 22); each group had the same proportion of patients with tumors of different locations (head or neck vs body or tail).The procedure was standardized among all endoscopists and placement of a minimum of 3 markers inside the tumor was defined as technical success. The times for procedure and fiducial placement were recorded, total number of fiducial markers used documented, and grade of procedure difficulty ranked by passing the needle or deploying the fiducials. Other recorded variables included tumor characteristics, fluoroscopy use, and the number of fiducials clearly seen by EUS and fluoroscopy. The primary aim was to compare the duration of EUS-guided fiducial insertion of BLNs vs PLNs. RESULTS: The median placement time was significantly shorter in the PLN group (9 min) than the BLN group (16 min) (P < .001). However, the 44% reduction in time did not reach pre-specified levels (≥60%). Similar results were found after stratifying by tumor location. Deployment of BLNs was easier than deployment of PLNs (P = .03). There was no significant difference between groups in technical success, number of fiducials placed, EUS or fluoroscopic visualization, or adverse events. During simulation computed tomography and image-guided radiation therapy, there was no difference between groups in visualization of fiducials, migration rate, or accuracy of placement. CONCLUSIONS: In a randomized controlled trial of 44 patients with pancreatic adenocarcinoma, we found EUS-guided placement of PLNs to require less time and produce similar results compared with BLNs. Further refinements in PLN delivery system are needed to increase the ease of deployment. Clinicaltrials.gov no: NCT02332863.

Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography, From Training Through Independent Practice.

BACKGROUND & AIMS: It is unclear whether participation in competency-based fellowship programs for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) results in high-quality care in independent practice. We measured quality indicator (QI) adherence during the first year of independent practice among physicians who completed endoscopic training with a systematic assessment of competence. METHODS: We performed a prospective multicenter cohort study of invited participants from 62 training programs. In phase 1, 24 advanced endoscopy trainees (AETs), from 20 programs, were assessed using a validated competence assessment tool. We used a comprehensive data collection and reporting system to create learning curves using cumulative sum analysis that were shared with AETs and trainers quarterly. In phase 2, participating AETs entered data into a database pertaining to every EUS and ERCP examination during their first year of independent practice, anchored by key QIs. RESULTS: By the end of training, most AETs had achieved overall technical competence (EUS 91.7%, ERCP 73.9%) and cognitive competence (EUS 91.7%, ERCP 94.1%). In phase 2 of the study, 22 AETs (91.6%) participated and completed a median of 136 EUS examinations per AET and 116 ERCP examinations per AET. Most AETs met the performance thresholds for QIs in EUS (including 94.4% diagnostic rate of adequate samples and 83.8% diagnostic yield of malignancy in pancreatic masses) and ERCP (94.9% overall cannulation rate). CONCLUSIONS: In this prospective multicenter study, we found that although competence cannot be confirmed for all AETs at the end of training, most meet QI thresholds for EUS and ERCP at the end of their first year of independent practice. This finding affirms the effectiveness of training programs. Clinicaltrials.gov ID NCT02509416.

Anatomic location of Barrett's esophagus recurrence after endoscopic eradication therapy: development of a simplified surveillance biopsy strategy.

BACKGROUND AND AIMS: Surveillance endoscopy is recommended after endoscopic eradication therapy (EET) for Barrett's esophagus (BE) because of the risk of recurrence. Currently recommended biopsy protocols are based on expert opinion and consist of sampling visible lesions followed by random 4-quadrant biopsy sampling throughout the length of the original BE segment. Despite this protocol, some recurrences are not visibly identified. We aimed to identify the anatomic location and histology of recurrences after successful EET with the goal of developing a more efficient and evidence-based surveillance biopsy protocol. METHODS: We performed an analysis of a large multicenter database of 443 patients who underwent EET and achieved complete eradication of intestinal metaplasia (CE-IM) from 2005 to 2015. The endoscopic location of recurrence relative to the squamocolumnar junction (SCJ), visible recurrence identified during surveillance endoscopy, and time to recurrence after CE-IM were assessed. RESULTS: Fifty patients with BE recurrence were studied in the final analysis. Seventeen patients (34%) had nonvisible recurrences. In this group, biopsy specimens demonstrating recurrence were taken from within 2 cm of the SCJ in 16 of these 17 patients (94%). Overall, 49 of 50 recurrences (98%) occurred either within 2 cm of the SCJ or at the site of a visible lesion. Late recurrences (>1 year) were more likely to be visible than early (<1 year) recurrences (P = .006). CONCLUSIONS: Recurrence after EET detected by random biopsy sampling is identified predominately in the distal esophagus and occurs earlier than visible recurrences. As such, we suggest a modified biopsy protocol with targeted sampling of visible lesions followed by random biopsy sampling within 2 cm of the SCJ to optimize detection of recurrence after EET. (Clinical trial registration number: NCT02634645.).

A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video).

BACKGROUND AND AIMS: Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent. METHODS: A phase III, multicenter, prospective, noninferiority, randomized controlled trial was conducted on patients with malignant dysphagia requiring SEMSs to be placed across the GEJ. Patients were randomized to receive SEMSs with no valve (SEMS-NV) or SEMS-V. Postdeployment dysphagia score at 2 weeks and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire score at 4 weeks were measured. Patients were followed for 24 weeks. RESULTS: Sixty patients were randomized (SEMS-NV: 30 patients, mean age 67 ± 13 years; SEMS-V: 30 patients, mean age 65 ± 12 years). Baseline dysphagia scores (SEMS-NV, 2.5 ± .8; SEMS-V, 2.5 ± .8) and GERD-HRQL scores (SEMS-NV, 11.1 ± 8.2; SEMS-V, 12.8 ± 8.3) were similar. All SEMSs were successfully deployed. A similar proportion of patients in both arms improved from advanced dysphagia to moderate to no dysphagia (SEMS-NV, 71%; SEMS-V, 74%; 95% confidence interval, 1.93 [-17.8 to 21.7]). The dysphagia scores were also similar across all follow-up time points. Mean GERD-HRQL scores improved by 7.4 ± 10.2 points in the SEMS-V arm and by 5.2 ± 8.3 in the SEMS-NV group (P = .96). The GERD-HRQL scores were similar across all follow-up time points. Aspiration pneumonia occurred in 3.3% in the SEMS-NV arm and 6.9% in the SEMS-V arm (P = .61). Migration rates were similar (SEMS-NV, 33%; SEMS-V, 48%; P = .29). Two SEMS-V spontaneously fractured. There was no perforation, food impaction, or stent-related death in either group. CONCLUSIONS: The SEMS-V was equally effective in relieving dysphagia as compared with the SEMS-NV. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents, implying either that the valve was not effective or that all patients on proton pump inhibitors could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended. (Clinical trial registration number: NCT02159898.).

Setting minimum standards for training in EUS and ERCP: results from a prospective multicenter study evaluating learning curves and competence among advanced endoscopy trainees.

BACKGROUND AND AIMS: Minimum EUS and ERCP volumes that should be offered per trainee in "high quality" advanced endoscopy training programs (AETPs) are not established. We aimed to define the number of procedures required by an "average" advanced endoscopy trainee (AET) to achieve competence in technical and cognitive EUS and ERCP tasks to help structure AETPs. METHODS: American Society for Gastrointestinal Endoscopy (ASGE)-recognized AETPs were invited to participate; AETs were graded on every fifth EUS and ERCP examination using a validated tool. Grading for each skill was done using a 4-point scoring system, and learning curves using cumulative sum analysis for overall, technical, and cognitive components of EUS and ERCP were shared with AETs and trainers quarterly. Generalized linear mixed-effects models with a random intercept for each AET were used to generate aggregate learning curves, allowing us to use data from all AETs to estimate the average learning experience for trainees. RESULTS: Among 62 invited AETPs, 37 AETs from 32 AETPs participated. Most AETs reported hands-on EUS (52%, median 20 cases) and ERCP (68%, median 50 cases) experience before starting an AETP. The median number of EUS and ERCPs performed per AET was 400 (range, 200-750) and 361 (range, 250-650), respectively. Overall, 2616 examinations were graded (EUS, 1277; ERCP-biliary, 1143; pancreatic, 196). Most graded EUS examinations were performed for pancreatobiliary indications (69.9%) and ERCP examinations for ASGE biliary grade of difficulty 1 (72.1%). The average AET achieved competence in core EUS and ERCP skills at approximately 225 and 250 cases, respectively. However, overall technical competence was achieved for grade 2 ERCP at about 300 cases. CONCLUSION: The thresholds provided for an average AET to achieve competence in EUS and ERCP may be used by the ASGE and AETPs in establishing the minimal standards for case volume exposure for AETs during their training. (Clinical trial registration number: NCT02509416.).

Treating Biliary-Enteric Anastomotic Strictures with Enteroscopy-ERCP Requires Fewer Procedures than Percutaneous Transhepatic Biliary Drains.

BACKGROUND: Biliary-enteric anastomotic strictures (AS) in long-limb surgical biliary bypass (LLBB) require percutaneous transhepatic biliary drains (PTBD), enteroscopy-assisted ERCP (E-ERCP), or surgical revision. AIM: To compare E-ERCP and PTBD for AS treatment. METHODS: E-ERCP stricturoplasty included dilation, cautery, and stent; PTBD included balloon dilation and serial drain upsizing events. RESULTS: From May 2008 to October 2015, 71 patients (37 M, median age 52) had E-ERCP (n = 45) or PTBD (n = 26) for AS in Roux-en-Y hepaticojejunostomy: liver transplant (n = 28), cholecystectomy injury revision (n = 21), other (n = 13) or Whipple's resection (n = 9). Median follow-up is 11 months (range 1-56) in 67 (94%) patients. Technical success, clinical improvement, and adverse events between E-ERCP and PTBD were similar (76% vs. 77%, p = 0.89; 82% vs. 85%, p = 0.80, and 6% vs. 5%, p = 0.60, respectively). However, E-ERCP had fewer post-procedural hospitalization days (0.2 ± 0.65 vs. 4.5±10, p = 0.0001), mean procedures (4.4 ± 6.3 vs. 9.5 ± 8, p = 0.006), and median months of treatment to resolve AS (1, range 1-22 vs. 7, range 3-23; p = 0.003). Two patients in PTBD group required surgery. CONCLUSIONS: (1) Technical success and clinical improvement are seen in the majority of LLBB patients with biliary-enteric AS undergoing E-ERCP or PTBD. (2) E-ERCP is associated with fewer procedures, post-procedure hospitalization days, and months to resolve AS. When expertise is available, E-ERCP to identify and treat AS should be considered as an alternative to PTBD.

Technical feasibility, diagnostic yield, and safety of microforceps biopsies during EUS evaluation of pancreatic cystic lesions (with video).

BACKGROUND AND AIMS: Through-the-needle microforceps are a recent addition to the EUS armamentarium for evaluation of pancreatic cystic lesions (PCLs). The main aim of this study was to assess the technical feasibility, diagnostic yield, and safety of EUS-guided microforceps biopsy for PCLs. METHODS: Our electronic endoscopy database was queried to identify patients who underwent EUS-guided FNA (EUS-FNA) of PCLs and microforceps biopsies during the same procedure. A biopsy was done on the wall of the cyst with the microforceps through the 19-gauge needle, and cyst fluid was collected for cytology and carcinoembryonic antigen (CEA) levels. Adverse events were recorded per published American Society for Gastrointestinal Endoscopy criteria. RESULTS: Twenty-seven patients underwent EUS-FNA and microforceps biopsy of PCLs from February 2016 to July 2017. Fourteen cysts were located in the pancreatic head and/or uncinate, and 13 were located in the body and/or tail region. Microforceps biopsies were technically successful in all cases and provided a pathology diagnosis in 24 of 27 cases (yield 88.9%). Microforceps biopsies diagnosed mucinous cyst in 9 patients (33.3%), serous cystadenoma in 4 (14.8%), neuroendocrine tumor in 1 (3.7%), and benign and/or inflammatory cyst in 10 (37.1%). In 7 patients (26%), microforceps biopsy results drastically changed the diagnosis, providing diagnoses otherwise not suggested by cytology or cyst fluid CEA levels. However, cytology provided a diagnosis of mucinous cyst in 4 cases (14.8%) not detected by microforceps biopsies. No adverse events were noted. CONCLUSION: Microforceps biopsies were associated with high technical success, and an excellent safety profile and may be a useful adjunctive tool, complementing existing EUS-FNA sampling protocols for PCLs.

Multicenter evaluation of the clinical utility of laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass.

BACKGROUND AND AIMS: The obesity epidemic has led to increased use of Roux-en-Y gastric bypass (RYGB). These patients have an increased incidence of pancreaticobiliary diseases, yet standard ERCP is not possible because of surgically altered gastroduodenal anatomy. Laparoscopy-assisted ERCP (LA-ERCP) has been proposed as an option, but supporting data are derived from single-center small case series. Therefore, we conducted a large multicenter study to evaluate the feasibility, safety, and outcomes of LA-ERCP. METHODS: This is a retrospective cohort study of adult patients with RYGB who underwent LA-ERCP in 34 centers. Data on demographics, indications, procedure success, and adverse events were collected. Procedure success was defined when all the following were achieved: reaching the papilla, cannulating the desired duct, and providing endoscopic therapy as clinically indicated. RESULTS: A total of 579 patients (median age, 51; 84% women) were included. Indication for LA-ERCP was biliary in 89%, pancreatic in 8%, and both in 3%. Procedure success was achieved in 98%. Median total procedure time was 152 minutes (interquartile range [IQR], 109-210), with a median ERCP time of 40 minutes (IQR, 28-56). Median hospital stay was 2 days (IQR, 1-3). Adverse events were 18% (laparoscopy related, 10%; ERCP related, 7%; both, 1%) with the clear majority (92%) classified as mild/moderate, whereas 8% were severe and 1 death occurred. CONCLUSIONS: Our large multicenter study indicates that LA-ERCP in patients with RYGB is feasible with a high procedure success rate comparable with that of standard ERCP in patients with normal anatomy. The ERCP-related adverse events rate is comparable with conventional ERCP, but the overall adverse event rate was higher because of the added laparoscopy-related events.

Advanced ERCP techniques for the extraction of complex biliary stones: a single referral center's 12-year experience.

OBJECTIVES: Advanced ERCP techniques (AETs) for difficult biliary stones include peroral cholangioscopy (POC) with electrohydraulic/laser lithotripsy (EHL/LL), endoscopic papillary large balloon dilation (EPLBD) and mechanical lithotripsy (ML). We assess the efficacy of AETs. METHODS: A retrospective query for AETs. PRIMARY OUTCOME: Complete duct clearance. Secondary outcome: Complete duct clearance by technique. Statistical Analysis version 9.3 (SAS Inc., Cary, NC). RESULTS: From 1/00 to 10/12, 349 patients were identified of which 222 (80% had prior ERCPs) had AETs. 211 with sufficient follow-up underwent 295 ERCPs; 280 of which were AET's. Index AETs: POC with EHL/LL (n = 46/211, 22%), ML (n = 84/211, 40%), EPLBD with mean balloon size of 11.5 ± 1.7 mm (n = 39/211, 18%) and combination AETs (n = 42/211, 20%). Stone characteristics: 76% had ≥1 stone, 81% extrahepatic and 32% had strictures. Number of stones (mean 2.5 and range 1-20) did not differ among groups. EPLBD had higher percentage (95%) of extrahepatic stones (p = .0003). The 'Combination' and 'POC' groups had larger stones (mean 17.7 mm ±6.4 and 16.8 mm ±6.1, respectively; p < .001). Complete clearance: 209/211 (99%) at index AET 167/211 (79%) or after mean of 2.5 ± 0.7 AETs in 42/211 (20%). Partial clearance: 2/211 (1%). Clearance at index AETs was higher with EPLBD (90%, p = .014). Adverse Events: 7/280 (2.5%). CONCLUSIONS: AETs achieved clearance in 99%. EPLBD had higher clearance at index AET likely owing to higher extrahepatic stones. Larger stones, but not number, were associated with increased combination AETs and total ERCPs.

Increasing Number of Passes Beyond 4 Does Not Increase Sensitivity of Detection of Pancreatic Malignancy by Endoscopic Ultrasound-Guided Fine-Needle Aspiration.

BACKGROUND & AIMS: It is not clear exactly how many passes are required to determine whether pancreatic masses are malignant using endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). We aimed to define the per-pass diagnostic yield of EUS-FNA for establishing the malignancy of a pancreatic mass, and identify factors associated with detection of malignancies. METHODS: In a prospective study, 239 patients with solid pancreatic masses were randomly assigned to groups that underwent EUS-FNA, with the number of passes determined by an on-site cytopathology evaluation or set at 7 passes, at 3 tertiary referral centers. A final diagnosis of pancreatic malignancy was made based on findings from cytology, surgery, or a follow-up evaluation at least 1 year after EUS-FNA. The cumulative sensitivity of detection of malignancy by EUS-FNA was calculated after each pass; in the primary analysis, lesions categorized as malignant or suspicious were considered as positive findings. RESULTS: Pancreatic malignancies were found in 202 patients (84.5% of the study population). EUS-FNA detected malignancies with 96% sensitivity (95% confidence interval [CI], 92%-98%); 4 passes of EUS-FNA detected malignancies with 92% sensitivity (95% CI, 87%-95%). Tumor size greater than 2 cm was the only variable associated with positive results from cytology analysis (odds ratio, 7.8; 95% CI, 1.9-31.6). In masses larger than 2 cm, 4 passes of EUS-FNA detected malignancies with 93% sensitivity (95% CI, 89%-96%) and in masses ≤2 cm, 6 passes was associated with 82% sensitivity (95% CI, 61%-93%). Sensitivity of detection did not increase with increasing number of passes. CONCLUSIONS: In a prospective study, we found 4 passes of EUS-FNA to be sufficient to detect malignant pancreatic masses; increasing the number of passes did not increase the sensitivity of detection. Tumor size greater than 2 cm was associated with malignancy, and a greater number of passes may be required to evaluate masses 2 cm or less. ClinicalTrials.gov number, NCT01386931.

Per-oral video cholangiopancreatoscopy with narrow-band imaging for the evaluation of indeterminate pancreaticobiliary disease.

BACKGROUND AND AIMS: Cholangiopancreatoscopy for evaluating pancreaticobiliary pathology is currently limited by suboptimal optics. The aim of this study was to characterize the operating characteristics of per-oral video cholangiopancreatoscopy with narrow-band imaging (POVCP) findings in indeterminate pancreaticobiliary disease and to describe their association with neoplasia. METHODS: Data from consecutive patients undergoing POVCP for the evaluation of indeterminate pancreaticobiliary disease at a single tertiary care center were analyzed. Two experienced investigators had previously agreed on POVCP findings and terminology that were documented in endoscopy reports. Endoscopic procedural data from POVCPs performed between January 2006 and April 2015 and clinical data were abstracted from the endoscopic database and electronic medical records. Study endpoints included tissue-proven neoplasia or benign disease with ≥1 year of follow-up. RESULTS: A total of 109 patients were identified; 13 were excluded because of the presence of stone disease, known pancreaticobiliary malignancy, or presumed benign disease with ≤1 year of follow-up. Most patients (85%) underwent POVCP for biliary disease and 15% underwent POVCP for a pancreatic cause. Tortuous and dilated vessels (P < .001), infiltrative stricture (P < .001), polypoid mass (P = .003), and the presence of fish-egg lesions (P = .04) were found to be significantly associated with neoplasia. The overall POVCP impression had a high sensitivity (85%) and negative predictive value (89%) in assessing for the presence of neoplasia. CONCLUSIONS: Per-oral video cholangiopancreatoscopy is effective in the evaluation of indeterminate pancreaticobiliary disease. Tortuous and dilated vessels, infiltrative stricture, polypoid mass, and the presence of fish-egg lesions are significantly associated with neoplasia.

Role of per-oral pancreatoscopy in the evaluation of suspected pancreatic duct neoplasia: a 13-year U.S. single-center experience.

BACKGROUND AND AIMS: The role of per-oral pancreatoscopy (POP) in the evaluation of occult pancreatic duct (PD) lesions remains limited to case series. The aim of this study was to evaluate the ability of POP to differentiate malignant from benign diseases of the PD. METHODS: Patients who underwent POP between 2000 and 2013 for the evaluation of indeterminate PD strictures, dilatations, or with suspected or known main duct intraductal papillary mucinous neoplasm were identified. Main outcome measurements were visual impression accuracy, POP tissue sampling, efficacy, and safety of POP. RESULTS: During the study period, 79 patients who underwent POP for the evaluation of pancreatic stricture or dilatation were identified. Technical success was achieved in 78 (97%). In the PD neoplasia group (n = 33), the final diagnosis was based on index confirmatory POP-guided tissue sampling in 29 (88%). For the detection of PD neoplasia, POP visual impression had a sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 87%, 86%, 83%, 91%, and 87%, respectively. When combined with POP-guided tissue sampling, the values were 91%, 95%, 94%, 93%, and 94%, respectively. Of 102 POPs performed, adverse events were noted in 12 (12%) cases. CONCLUSIONS: This study demonstrates a high technical success rate, visual impression accuracy, and tissue sampling capability of POP. Examinations were performed by endoscopists with expertise in pancreatoscopy interpretation, and the results may not be generalizable.

Minor papilla endotherapy in patients with ventral duct obstruction: identification and management.

BACKGROUND AND AIMS: Pancreatic duct (PD) cannulation via the major papilla may be compromised by downstream obstruction of the ventral PD from a stone or stricture. In patients with a patent accessory PD, cannulation of the minor papilla permits stenting or stone removal upstream of the ventral PD obstruction. Data on this technique are limited. METHODS: University of Colorado Hospital and Maine Medical Center endoscopy databases were queried for ERCPs with minor papilla cannulation. Technical success was defined as deep cannulation of the minor papilla. Minor papilla endotherapy included sphincterotomy, stricture dilation, stenting, or stone treatment. Clinical improvement was designated as >50% reduction in pain or narcotic analgesia. Follow-up was obtained by chart review and telephone contact. RESULTS: Over a 22-year period, 464 patients had minor papilla cannulation. Congenital and incomplete pancreas divisum were excluded, and 64 patients met study criteria. Technical success was achieved in 58 of 64 patients (91%). In patients with stones, 25 of 34 (74%) had clearance using endoscopic techniques. Median follow-up was 15.5 months. Twelve of 28 patients (43%) on chronic narcotic regimens reported a reduction in narcotic use by >50%, and 32 of 44 patients (73%) reached for discussion noted improved abdominal pain by >50%. Thirteen patients required surgery for symptom control. CONCLUSIONS: In this multicenter experience, 15% of patients undergoing minor papilla cannulation had acquired a ventral PD obstruction. Access via the minor papilla to the upstream main PD for endotherapy and clinical improvement was achieved in most patients. Increased and early recognition of these intensive therapeutic options may enhance treatment options for this complex group of patients.

EUS-guided Gastrojejunostomy Versus Laparoscopic Gastrojejunostomy: An International Collaborative Study.

INTRODUCTION: Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) with placement of a lumen-apposing metal stent is a minimally invasive and efficacious procedure for gastric outlet obstruction (GOO) patients not amenable to surgery. Laparoscopic gastrojejunostomy (Lap-GJ) has traditionally been the standard of care. No direct comparison between EUS-GJ and Lap-GJ has been described. Our aim was to compare the clinical outcomes, success rate, and adverse events (AE) of EUS-GJ with Lap-GJ. METHODS: Patients with GOO from 4 academic centers in 3 countries were included. Technical success was defined as successful creation of a gastrojejunostomy. Clinical success was defined as the ability to tolerate a diet postprocedure. RESULTS: Data were collected on 54 patients. A total of 25 patients underwent EUS-GJ (male n=11, mean age 63.9 y) and 29 patients underwent Lap-GJ (male n=22, mean age 75.8 y). Technical success was achieved in 29 (100%) Lap-GJ group patients and 23 (88%) in the EUS-GJ group (P=0.11). AEs occurred in 41% (n=12) of patients in the Lap-GJ group and 12% (n=3) in the EUS-GJ group (P=0.0386). According to the Clavien-Dindo Classification, the Lap-GJ group AEs were grade I (n=4), grade II (n=5), grade III (n=2), and grade V (n=1); the EUS-GJ AEs were grade II (n=2) and grade V (n=1). CONCLUSIONS: Although the EUS-GJ group contained more complex patients, efficacy was similar between the groups. AEs were significantly lower in the EUS-GJ group. EUS-GJ is a safe and efficacious, minimally invasive option for patients with GOO.

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.

Safety and efficacy of endoscopic ultrasound-guided drainage of pancreatic fluid collections with lumen-apposing covered self-expanding metal stents.

BACKGROUND & AIMS: Plastic stents, placed via endoscopy to drain pancreatic fluid collections (PFCs), require repeat access. Covered metal stents are larger in diameter and can be inserted in a single step, but can migrate. We evaluated the safety and efficacy of a lumen-apposing, covered, self-expanding metal stent (LACSEMS) for PFC drainage. METHODS: We performed a prospective study of the outcomes of stent placement in 33 patients (18 men; age, 53 ± 14 y; 28 with chronic pancreatitis) with symptomatic pancreatic pseudocysts and walled-off necrosis (≥ 6 cm with ≥ 70% fluid content). Subjects were enrolled at 7 tertiary care centers (6 in the United States and 1 in Europe) from October 2011 through August 2013. Cystenterostomies were created based on endoscopist preference. Safety outcomes included infection, bleeding, perforation, tissue injury, and stent migration. Efficacy end points included LACSEMS placement, patency, and removal, as well as 50% or more reduction in PFCs. RESULTS: The mean size of the patients' PFCs was 9 ± 3.3 cm. LACSEMSs were placed successfully via endoscopic ultrasound guidance in 30 patients (91%); the remaining 3 patients received 2 double-pigtail stents. One subject could not be evaluated because of a pseudoaneurysm. In the patients receiving LACSEMS, PFCs resolved in 27 of 29 (93%). Overall, PFCs resolved in 30 of 33 patients (91%). Endoscopic debridement through the LACSEMS was conducted in 11 subjects. Complications (15%) included abdominal pain (n = 3), spontaneous stent migration, back pain (n = 1), access-site infection, and stent dislodgement (n = 1). CONCLUSIONS: LACSEMS were placed successfully in 91% of subjects with PFCs. Overall, 93% had PFC resolution. Advantages of LACSEMSs over other stents include single-step deployment and the ability to perform endoscopic debridement with minimal stent migration. Clinicaltrials.gov: NCT01419769.

Suboptimal accuracy of carcinoembryonic antigen in differentiation of mucinous and nonmucinous pancreatic cysts: results of a large multicenter study.

BACKGROUND AND AIMS: The exact cutoff value at which pancreatic cyst fluid carcinoembryonic antigen (CEA) level distinguishes pancreatic mucinous cystic neoplasms (MCNs) from pancreatic nonmucinous cystic neoplasms (NMCNs) is unclear. The aim of this multicenter retrospective study was to evaluate the diagnostic accuracy of cyst fluid CEA levels in differentiating between MCNs and NMCNs. METHODS: Consecutive patients who underwent EUS with FNA at 3 tertiary care centers were identified. Patients with histologic confirmation of cyst type based on surgical specimens served as the criterion standard for this analysis. Demographic characteristics, EUS morphology, FNA fluid, and cytology results were recorded. Multivariate logistic regression analysis to identify predictors of MCNs was performed. Receiver-operating characteristic (ROC) curves were generated for CEA levels. RESULTS: A total of 226 patients underwent surgery (mean age, 61 years, 96% white patients, 39% female patients) of whom 88% underwent Whipple's procedure or distal pancreatectomy. Based on surgical histopathology, there were 150 MCNs and 76 NMCNs cases. The median CEA level was 165 ng/mL. The area under the ROC curve for CEA levels in differentiating between MCNs and NMCNs was 0.77 (95% confidence interval, 0.71-0.84, P < .01) with a cutoff of 105 ng/mL, demonstrating a sensitivity and specificity of 70% and 63%, respectively. The cutoff value of 192 ng/mL yielded a sensitivity of 61% and a specificity of 77% and would misdiagnose 39% of MCN cases. CONCLUSIONS: Cyst fluid CEA levels have a clinically suboptimal accuracy level in differentiating MCNs from NMCNs. Future studies should focus on novel cyst fluid markers to improve risk stratification of pancreatic cystic neoplasms.