Digital Single-operator Cholangioscopy (DSOC) Improves Interobserver Agreement (IOA) and Accuracy for Evaluation of Indeterminate Biliary Strictures: The Monaco Classification.

BACKGROUND: Visual characteristics seen during digital single-operator cholangioscopy (DSOC) have not been validated. The aim of this 2-phase study was to define terminology by consensus for the visual diagnosis of biliary lesions to develop a model for optimization of the diagnostic performance of DSOC. MATERIALS AND METHODS: In phase 1 (criteria identification), video-cholangioscopy clips were reviewed by 12 expert biliary endoscopists, who were blinded to the final diagnosis. Visual criteria were consolidated into the following categories: (1) stricture, (2) lesion, (3) mucosal features, (4) papillary projections, (5) ulceration, (6) abnormal vessels, (7) scarring, (8) pronounced pit pattern.During the second phase (validation), 14 expert endoscopists reviewed DSOC (SpyGlass DS, Boston Scientific) clips using the 8 criteria to assess interobserver agreement (IOA) rate. RESULTS: In phase 1, consensus for visual findings were categorized into 8 criteria titled the "Monaco Classification." The frequency of criteria were: (1) presence of stricture-75%, (2) presence of lesion type-55%, (3) mucosal features-55%, (4) papillary projections-45%, (5) ulceration-42.5%, (6) abnormal vessels-10%, (7) scarring-40%, and (8) pronounced pit pattern-10%. The accuracy on final diagnosis based on visual impression alone was 70%.In phase 2, the IOA rate using Monaco Classification criteria ranged from slight to fair. The presumptive diagnosis IOA was fair (κ=0.31, SE=0.02), and overall diagnostic accuracy was 70%. CONCLUSIONS: The Monaco classification identifies 8 visual criteria for biliary lesions on single-operator digital cholangioscopy. Using the criteria, the IOA and diagnostic accuracy rate of DSOC is improved compared with prior studies.

Probe-based confocal laser endomicroscopy in the evaluation of dominant strictures in patients with primary sclerosing cholangitis: results of a U.S. multicenter prospective trial.

BACKGROUND AND AIMS: Patients with primary sclerosing cholangitis (PSC) and dominant biliary strictures carry increased risk for the development of cholangiocarcinoma. Although ERCP-based techniques including brush cytology and intraductal biopsy sampling represent first-line tissue sampling methods for dominant strictures, sensitivity is low. Probe-based confocal laser endomicroscopy (pCLE) offers microscopic-level imaging of subepithelial biliary mucosa. Because data regarding the use of pCLE in PSC are limited, we aimed to investigate its diagnostic performance in dominant strictures. METHODS: This was a multicenter prospective study involving PSC patients with dominant strictures. ERCP with pCLE was performed with use of the Miami classification (2+ criteria for malignant diagnosis) and Paris classification. Final malignant diagnoses required histopathologic confirmation, and benign diagnoses required a minimum of 1 year of follow-up without development of cancer. RESULTS: Fifty-nine patients (mean age, 49 years; 59% men) with 63 strictures were included in the study. Stricture locations included the common bile duct (31.7%), bifurcation (22.2%), and common hepatic duct (19%). Seven patients (11.9%) were found to have cholangiocarcinoma. The sensitivity and specificity of pCLE was 85.7% (95% confidence interval [CI], 42.1-99.6) and 73.1% (95% CI, 58.9-84.4), respectively. Within specific stricture locations, the highest sensitivity was seen at the bifurcation (100%; 95% CI, 2.5-100) and the right hepatic duct (100%; 95% CI, 29.2-100). The lowest sensitivities were seen at the common bile duct (25%; 95% CI, 5.5-57.2) and the left hepatic duct (28.6%; 95% CI, 3.7-70.9). CONCLUSIONS: In this prospective multicenter study, pCLE had a high sensitivity in detecting cholangiocarcinoma, but technical aspects of the probe may limit evaluation in the common bile duct and left hepatic duct. Further evaluation is needed to elucidate the role of pCLE in the algorithm of excluding neoplasia in biliary strictures associated with PSC. (Clinical trial registration number: NCT02736708.).

EUS-Directed Transgastric Endoscopic Retrograde Cholangiopancreatography (EDGE): The First Learning Curve.

INTRODUCTION: Endoscopic ultrasound (EUS)-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) is a minimally invasive option for pancreaticobiliary access in patients with Roux-en-Y anatomy. The procedure involves creating a fistulous tract between the remnant stomach or jejunum and the bypassed stomach with the deployment of a lumen-apposing metal stent (LAMS), followed by the advancement of an endoscope through the LAMS to perform an ERCP or EUS. It is a technically challenging procedure, requiring skills in EUS, fluoroscopy, and LAMS deployment. The aim of this study was to determine the learning curve for EDGE. METHODS: Consecutive patients undergoing EDGE by a single operator were included from a prospective registry over 3 years. Demographics, procedure info, postprocedure follow-up data, and adverse events were collected. Nonlinear regression and cumulative sum analyses were conducted for the learning curve. Technical success was defined as the successful creation of the fistulous tract. Clinical success was defined as successful EUS or ERCP via the LAMS. RESULTS: Nineteen patients were included (21% male, mean age 58.7 y). Indication included symptomatic biliary stricture (n=6, 32%), choledocholithiasis (n=5, 26%), pancreatitis (n=3, 16%). Technical success was 100%. All patients had a 15 mm LAMS placed, 3 (16%) had cautery-enhanced LAMS. Clinical success was achieved in 18/19 (95%) patients. Fourteen patients had an ERCP, 1 patient had a EUS, and 3 patients had both. Adverse events included 2 cases of bleeding, 1 case of post-ERCP pancreatitis, and 1 jejunal perforation during duodenoscope insertion managed endoscopically.Median procedure time was 54.5 minutes (range: 31 to 88 min). Cumulative sum chart shows a 54-minute procedure time was achieved at the ninth procedure hence indicating efficiency. Apart from 2 outliers, the procedure duration further reduced with consequent procedures with the last 3 being under 40 minutes indicating that after 25 to 35 procedures a plateau may be reached indicating mastery (nonlinear regression P<0.0001). CONCLUSIONS: Endoscopists experienced in EDGE are expected to achieve a reduction in procedure time over successive cases, with efficiency reached 54.5 minutes and a learning rate of 9 cases. After 25 to 35 procedures, a plateau may be reached indicating mastery.

EUS-directed Transgastric ERCP (EDGE) Versus Laparoscopy-assisted ERCP (LA-ERCP) for Roux-en-Y Gastric Bypass (RYGB) Anatomy: A Multicenter Early Comparative Experience of Clinical Outcomes.

BACKGROUND AND AIMS: The standard of care for managing pancreaticobiliary disease in altered Roux-en-Y gastric bypass patients is laparoscopy-assisted endoscopic retrograde cholangiopancreatography (LA-ERCP), but is limited by cost and adverse events. Recently a minimally invasive, completely endoscopic approach using endoscopic ultrasound (EUS) directed transgastric ERCP (EDGE) has been described. We aim to compare EDGE to LA-ERCP in this study. METHODS: Patients from May 2005 to June 2017 with Roux-en-Y gastric bypass anatomy having undergone LA-ERCP or EDGE at 4 tertiary centers were captured in a registry. Patient demographics, procedural details, and clinical outcomes were measured for each group. RESULTS: Seventy-two patients (n=29 EDGE, n=43 LA-ERCP) were included in this study. There was no significant difference in the technical success of EDGE gastrogastric fistula (96.5%) versus LA-gastrostomy creation (100%). The success rate of achieving therapeutic ERCP (EDGE 96.5% vs. LA-ERCP 97.7%) and number of ERCP (EDGE 1.2 vs. LA-ERCP 1.02) needed to achieve clinical resolution was similar between both groups. Adverse event rate for EDGE, 24% (7/29) and LA-ERCP, 19% (8/43) was similar. The total procedure time (73 vs. 184 min) and length of hospital stay (0.8 vs. 2.65 d) was significantly shorter for EDGE compared to LA-ERCP. The overall weight change after EDGE was -6.6 lbs at an average 28-week follow-up. CONCLUSIONS: This study suggests that the EDGE procedure has similar technical success and adverse events compared with LA-ERCP with the benefit of significantly shorter procedure times and hospital stay. EDGE may offer a minimally invasive, effective option, with less resource utilization, and without significant weight gain.

Administration of secretin (RG1068) increases the sensitivity of detection of duct abnormalities by magnetic resonance cholangiopancreatography in patients with pancreatitis.

BACKGROUND & AIMS: Administration of secretin improves noninvasive imaging of the pancreatic duct with magnetic resonance cholangiopancreatography (MRCP). We performed a large prospective study to investigate whether synthetic human secretin (RG1068)-stimulated MRCP detects pancreatic duct abnormalities with higher levels of sensitivity than MRCP. METHODS: We performed a phase 3, multicenter, baseline-controlled study of patients with acute or acute recurrent pancreatitis who were scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP) between March 26, 2008, and October 28, 2009. Patients underwent a baseline MRCP that was immediately followed by administration of RG1068 and repeat MRCP and then underwent ERCP within 30 days; they were followed up for 30 days. MRCP and ERCP images were read centrally by 3 radiologists and 2 endoscopists, respectively, who were all independent and blinded; pancreatic duct abnormalities were evaluated. The accuracy of MRCP was evaluated using ERCP as the standard. RESULTS: In total, 258 patients were enrolled in the study; 251 MRCP image sets were assessed, and 236 patients had evaluable ERCPs. Pancreatic duct abnormalities were observed in 60.2% of ERCP images. All radiologists identified duct abnormalities in RG1068-ciné MRCP image sets with significantly higher levels of sensitivity (P < .0001) than in images from MRCP, with minimal loss of specificity. Adverse events were reported in 38.0% of patients after MRCP and 68.1% after ERCP. Of the 55 patients who experienced a serious adverse event, 3 (1.2%) and 52 (20.5%) of the events were reported to be temporally associated with MRCP and ERCP, respectively. The adverse events most frequently considered related to RG1068 were nausea, abdominal pain, and flushing; most were mild. CONCLUSIONS: Compared with images from MRCP, those from RG1068-stimulated MRCP are improved in many aspects and could aid in diagnosis and clinical decision making for patients with acute, acute recurrent, or chronic pancreatitis. RG1068-enhanced MRCP might also better identify patients in need of therapeutic ERCP (ClinicalTrials.gov, Number: NCT00660335).

Incidence and predictors of post-ERCP pancreatitis in patients with suspected sphincter of Oddi dysfunction undergoing biliary or dual sphincterotomy: results from the EPISOD prospective multicenter randomized sham-controlled study.

BACKGROUND AND STUDY AIM: Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a significant and potentially life-threatening adverse event and is common in patients with suspected sphincter of Oddi dysfunction (SOD). Here we aimed to identify predictors of the risk in this population. PATIENTS AND METHODS: The Evaluating Predictors and Interventions in SOD (EPISOD) study prospectively enrolled 214 post-cholecystectomy patients with SOD type III in seven US centers. Patients were randomized, using a 2:1 allocation, to sphincterotomy or sham procedure, irrespective of the results of sphincter of Oddi manometry. Patients in the sphincterotomy arm who had elevated pancreatic sphincter pressure were randomized to biliary only or to dual (biliary and pancreatic) sphincterotomy. All but one patient received prophylactic pancreatic stents, but none received pharmacological prophylaxis. Post ERCP pancreatitis (PEP) was defined as acute pancreatitis within the subsequent 7 days. Blinded research coordinators at each site called patients at 1 week post-procedure. RESULTS: PEP occurred in 26 patients, in 10.6 % (15/141) in the sphincterotomy arm and 15.1 % (11/73) in the sham arm; unadjusted relative risk 0.71 (95 % confidence interval [95 %CI] 0.34 - 1.46). PEP rate was not significantly different in patients who received sphincterotomy compared with those undergoing sham treatment. In addition, the proportion was not statistically different in those who received biliary sphincterotomy alone (12/94; 12.8 % [95 %CI 6.0 % - 19.5 %]) compared with dual sphincterotomy (3/47; 6.4 % [95 %CI 0.0 % - 13.4 %]). Multivariate analysis identified an interaction between duration of ERCP and sedation type (P < 0.02). CONCLUSION: The performance of biliary or dual sphincterotomy does not increase the risk of PEP in patients suspected of SOD. However, the high rate of PEP in patients with suspected SOD, despite pancreatic stenting in expert centers, is confirmed in this prospective study. The combined effect of duration of ERCP and sedation type on the development of PEP should be further explored.Clinicaltrials.gov registration: NCT00688662.

Can patient and pain characteristics predict manometric sphincter of Oddi dysfunction in patients with clinically suspected sphincter of Oddi dysfunction?

BACKGROUND: Biliopancreatic-type postcholecystectomy pain, without significant abnormalities on imaging and laboratory test results, has been categorized as "suspected" sphincter of Oddi dysfunction (SOD) type III. Clinical predictors of "manometric" SOD are important to avoid unnecessary ERCP, but are unknown. OBJECTIVE: To assess which clinical factors are associated with abnormal sphincter of Oddi manometry (SOM). DESIGN: Prospective, cross-sectional. SETTING: Tertiary. PATIENTS: A total of 214 patients with suspected SOD type III underwent ERCP and pancreatic SOM (pSOM; 85% dual SOM), at 7 U.S. centers (from August 2008 to March 2012) as part of a randomized trial. INTERVENTIONS: Pain and gallbladder descriptors, psychosocial/functional disorder questionnaires. MAIN OUTCOME MEASUREMENTS: Abnormal SOM findings. Univariate and multivariate analyses assessed associations between clinical characteristics and outcome. RESULTS: The cohort was 92% female with a mean age of 38 years. Baseline pancreatic enzymes were increased in 5%; 9% had minor liver enzyme abnormalities. Pain was in the right upper quadrant (RUQ) in 90% (48% also epigastric); 51% reported daily abdominal discomfort. Fifty-six took narcotics an average of 33 days (of the past 90 days). Less than 10% experienced depression or anxiety. Functional disorders were common. At ERCP, 64% had abnormal pSOM findings (34% both sphincters, 21% biliary normal), 36% had normal pSOM findings, and 75% had at least abnormal 1 sphincter. Demographic factors, gallbladder pathology, increased pancreatobiliary enzymes, functional disorders, and pain patterns did not predict abnormal SOM findings. Anxiety, depression, and poorer coping were more common in patients with normal SOM findings (not significant on multivariate analysis). LIMITATIONS: Generalizability. CONCLUSIONS: Patient and pain factors and psychological comorbidity do not predict SOM results at ERCP in suspected type III SOD. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00688662.).

Esophageal Perforation and Pneumomediastinum Due to Delayed Diagnosis of Esophageal Lichen Planus.

Esophageal involvement of lichen planus is an under-reported and under-diagnosed manifestation that should prompt immediate treatment given its high rate of complications. We highlight a rare case of a 62-year-old Caucasian woman with history of known oral lichen planus and esophageal strictures presumed to be secondary to gastroesophageal reflux disease, that presented with esophageal food impaction resulting in perforation and subsequent pneumomediastinum after esophagogastroduodenoscopy (EGD). Further workup, including a repeat EGD, revealed that the esophageal strictures were rather a complication of lichen planus. The patient was started on oral, topical steroids and underwent serial esophageal dilations with improvement. Esophageal lichen planus should be high on the differential, especially in patients with involvement of other mucous membranes and strictures refractory to therapy. Complications such as recurrent esophageal strictures and perforation may be preventable with early diagnosis and adequate treatment.

Severe Acute Pancreatitis Prediction: A Model Derived From a Prospective Registry Cohort.

Background Severe acute pancreatitis (SAP) has a mortality rate as high as 40%. Early identification of SAP is required to appropriately triage and direct initial therapies. The purpose of this study was to develop a prognostic model that identifies patients at risk for developing SAP of patients managed according to a guideline-based standardized early medical management (EMM) protocol. Methods This single-center study included all patients diagnosed with acute pancreatitis (AP) and managed with the EMM protocol Methodist Acute Pancreatitis Protocol (MAPP) between April 2017 and September 2022. Classification and regression tree (CART®; Professional Extended Edition, version 8.0; Salford Systems, San Diego, CA), univariate, and logistic regression analyses were performed to develop a scoring system for AP severity prediction. The accuracy of the scoring system was measured by the area under the receiver operating characteristic curve. Results A total of 516 patients with mild (n=436) or moderately severe and severe (n=80) AP were analyzed. CART analysis identified the cutoff values: creatinine (CR) (1.15 mg/dL), white blood cells (WBC) (10.5 × 109/L), procalcitonin (PCT) (0.155 ng/mL), and systemic inflammatory response system (SIRS). The prediction model was built with a multivariable logistic regression analysis, which identified CR, WBC, PCT, and SIRS as the main predictors of severity. When CR and only one other predictor value (WBC, PCT, or SIRS) met thresholds, then the probability of predicting SAP was >30%. The probability of predicting SAP was 72% (95%CI: 0.59-0.82) if all four of the main predictors were greater than the cutoff values. Conclusions Baseline laboratory cutoff values were identified and a logistic regression-based prognostic model was developed to identify patients treated with a standardized EMM who were at risk for SAP.

First interobserver agreement of optical coherence tomography in the bile duct: A multicenter collaborative study.

Background and study aims Optical coherence tomography (OCT) is a new technology available for evaluation of indeterminate biliary strictures. It allows under-the-surface visualization and preliminary studies have confirmed standardized characteristics associated with malignancy. The aim of this study is to evaluate the first interobserver agreement in identifying previously agreed upon OCT criteria and diagnosing of malignant versus benign disease. Patients and methods Fourteen endoscopists were asked to review an atlas of reference clips and images of eight criteria derived from expert consensus A total of 35 de-identified video clips were then evaluated for presence of the eight criteria and for final diagnosis of malignant versus benign using the atlas as reference Intraclass correlation (ICC) analysis was done to evaluate interrater agreement. Results Clips of 23 malignant lesions and 12 benign lesions were scored. Excellent interobserver agreement was seen with dilated hypo-reflective structures (0.85) and layering effacement (0.89); hyper-glandular mucosa (0.76), intact layering (0.81), and onion-skin layering (0.77); fair agreement was seen with scalloping (0.58), and thickened epithelium (0.4); poor agreement was seen with hyper-reflective surface (0.36). The diagnostic ICC for both neoplastic (0.8) and non-neoplastic (0.8) was excellent interobserver agreement. The overall diagnostic accuracy was 51 %, ranging from 43 % to 60 %. Conclusions Biliary OCT is a promising new modality for evaluation of indeterminate biliary strictures. Interobserver agreement ranged from fair to almost perfect on eight previously identified criteria. Interobserver agreement for malignancy diagnosis was substantial (0.8). Further studies are needed to validate this data.

A multicenter analysis of safety and outcome of removal of a fully covered self-expandable metal stent during ERCP.

BACKGROUND: Fully covered self-expandable metal stents (FCSEMSs) have been used for palliation of both malignant and benign biliary strictures. Limited data are available about safety and outcome of endoscopic removal of these stents. OBJECTIVE: To evaluate safety and efficacy of endoscopic removal of FCSEMSs. DESIGN: Retrospective review of patients who underwent endoscopic removal of Viabil FCSEMSs. SETTING: Four centers with experience in using FCSEMSs. PATIENTS: Thirty-seven patients who had stents endoscopically removed. INTERVENTION: ERCP with endoscopic removal of FCSEMSs. MAIN OUTCOME MEASUREMENTS: Feasibility, safety, and complications associated with endoscopic removal of FCSEMS. RESULTS: All 37 stent removal attempts were successful and were achieved without difficulty. Indwelling stent-related complications occurred in 4 of 37 patients, including secondary strictures in 3 and minor bile leak in 1. Two of 3 secondary strictures occurred at the distal stent margin of oversized intraductal stents, and another stricture occurred at a proximal stent margin of an oversized transpapillary stent. One case of minor confined intratumoral bile leak also occurred in a patient with metastatic urothelial cancer of the bile duct. All of these cases were successfully treated with repeat stenting and resolved without sequelae. No free perforations or significant bleeding occurred. LIMITATIONS: Retrospective study. CONCLUSION: Endoscopic removal of Viabil FCSEMSs placed for benign or malignant conditions is feasible and easily accomplished. Secondary strictures may be found at the time of stent removal or with a delayed presentation in patients with oversized stents who may require repeat stent placement.

Ablative therapies of the biliary tree.

Cholangiocarcinoma, a malignancy of the epithelial cells in the intrahepatic or extrahepatic biliary tree, is often diagnosed at later stages. Median survival duration ranges from 3 to 9 months with a less than ten percent 5-year survival rate. Thus, often treatment strategies are aimed more towards palliation instead of cure. With the majority of patients presenting with unresectable disease at the time of diagnosis, surgical intervention is not feasible, making less invasive endoscopic therapies more suitable. Initially, biliary stents were utilized for biliary decompression to mitigate cholestatic symptoms and prevent cholangitis; however, this strategy did not prove to provide significant survival benefit. Therefore, efforts to treat the tumor burden itself in addition to maintaining biliary patency became a focus of innovation and research in the endoscopic field. This study has led to the advent of therapies such as photodynamic therapy, radiofrequency ablation, and intraluminal brachytherapy. These options combined with biliary stenting have shown to not only offer the benefit of biliary decompression, but also to potentially improve stent patency and survival. Further, there is an anti-tumor effect of each of these modalities, portending an additional benefit in this subset of patients. Despite numerous retrospective and prospective studies assessing these ablative therapies, there is still a paucity of appropriately powered randomized controlled trials, and further research has yet to be done in the field. This review details the current literature entailing endobiliary ablative strategies.

Challenges in planning and initiating a randomized clinical study of sphincter of Oddi dysfunction.

BACKGROUND: Sphincter of Oddi dysfunction (SOD) is a controversial topic, especially in patients with no objective findings on laboratory or imaging studies (SOD type III). The value of ERCP manometry with sphincterotomy is unproven and carries significant risks. OBJECTIVE: To describe the process of planning and initiating a randomized sham-controlled study to establish whether patients with SOD respond to sphincter ablation, and whether the outcomes are predicted by the pain patterns, presence or absence of other functional GI or psychosocial problems, or the results of manometry. DESIGN: Planning a trial to establish which patients with "suspected SOD" (if any) respond to endoscopic sphincter ablation. SETTING: Meetings and correspondence by a planning group of gastroenterologists and clinical research specialists hosted at the Medical University of South Carolina. PATIENTS: Clarifying subject characteristics and inclusion and exclusion criteria. INTERVENTIONS: Defining the questionnaires, therapies, randomizations, and numbers of subjects required by outcome measures. Defining the metrics of success and failure. RESULTS: The planning resulted in funding for the proposed study as a cooperative agreement with the National Institute of Diabetes and Digestive and Kidney Diseases. LIMITATIONS: Lack of data required several consensus decisions in designing the protocol. CONCLUSION: The planning process was challenging, and some changes were needed after initiation.

Learning curve for EUS-guided biliary drainage: What have we learned?

BACKGROUND AND OBJECTIVE: EUS-guided-biliary drainage (EUS-BD) is an efficacious and safe option for patients who fail ERCP. EUS-BD is a technically challenging procedure. The aim of this study was to define the learning curve for EUS-BD. METHODS: Consecutive patients undergoing EUS-BD by a single operator were included for a prospective registry over 6 years. Demographics, procedural information, adverse events, and follow-up data were collected. Nonlinear regression and CUSUM analyses were conducted for the learning curve. Technical success was defined as successful stent placement. Clinical success was defined as resolution of jaundice and/or at least a 30% reduction in the pretreatment bilirubin level within a week after placement or normalization of bilirubin within 30 days. RESULTS: Seventy-two patients were included in the study (53% male, mean age 67 years). Technical success was achieved in 69 patients (96%). Clinical success was achieved in 59/69 patients (86%). Seven patients (10%) had adverse events including bleeding (n = 6) and liver abscess (n = 1). The median procedural time was 59 min (range 36-138 min). This was achieved at the 32nd procedure. Procedural durations were further reduced to 50 min and below after the 50th procedure in a nonlinear pattern. This suggests that procedural durations approach a potential plateau after 100 cases. CONCLUSION: Endoscopists experienced in EUS-BD are expected to achieve a reduction in procedural time over successive cases, with efficiency reached at 59 min and a learning rate of 32 cases. Continued improvement is demonstrated with additional experience, with mastery suggested after approximately 100 cases.

EUS-guided pancreatic drainage: A steep learning curve.

BACKGROUND AND OBJECTIVE: EUS-guided pancreatic drainage (EUS-PD) is an efficacious, acceptable risk option for patients with pancreatic duct obstruction who fail conventional ERCP. The aim of this study was to define the learning curve (LC) for EUS-PD. METHODS: Consecutive patients undergoing EUS-PD by a single operator were included from a dedicated registry. Demographics, procedural info, adverse events, and follow-up data were collected. Nonlinear regression and cumulative sum (CUSUM) analyses were conducted for the LC. RESULTS: Fifty-six patients were included (54% of male, with a mean age of 58 years). Technical success was achieved in 47 patients (84%). Stent placement was antegrade in 36 patients (77%) and retrograde in 11 (23%). Clinical success was achieved in 46/47 (98%) patients who achieved technical success. Adverse events were seen in 13 patients (6 of whom did not achieve technical success) and included bleeding requiring embolization (n = 5), bleeding treated with clips peri-procedurally (n = 1), pancreatitis (n = 5), and a pancreatic fluid collection drained via EUS-drainage (n = 2). The median procedural time was 80 min (range 49-159 min). The CUSUM chart showed that 80-min procedural time was achieved at the 27th procedure. Durations further reduced 40th procedure onward, reaching a plateau indicating proficiency (nonlinear regression P < 0.0001). CONCLUSION: Endoscopists experienced in EUS-PD are expected to achieve a reduction in procedural time over successive cases, with efficiency reached at 80 min and a learning rate of 27 cases. Continued improvement is demonstrated with additional experience, with plateau indicating mastery suggested at the 40th case. EUS-PD is probably one of the hardest therapeutic endosonographic procedures to learn.

Short 5Fr vs long 3Fr pancreatic stents in patients at risk for post-endoscopic retrograde cholangiopancreatography pancreatitis.

BACKGROUND & AIMS: Prophylactic placement of pancreatic duct (PD) stents reduces the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) in high-risk patients. Some endoscopists prefer longer length, unflanged 3Fr PD stents because they are supposedly more effective and have a higher rate of spontaneous dislodgement; we compared outcomes of patients with these 2 types of stents. METHODS: Patients at high risk for PEP were randomly assigned to groups given either a straight, 5Fr, 3 cm long, unflanged PD stent (n = 116) or a 3Fr, 8 cm or longer, unflanged PD stent (n = 133). Abdominal radiographs were obtained at 24 hours, 7 days, and 14 days following stent placement to assess spontaneous stent dislodgement. PEP was defined according to consensus criteria. RESULTS: After 14 days, the spontaneous stent dislodgement rates were 98% for 5Fr stents and 88% for 3Fr stents (P = .0001). PEP occurred in 12% of patients. The incidence of PEP was higher in the 3Fr group (14%) than the 5Fr group (9%), although this difference was not statistically significant (P = .3). Placement failure did not occur in any patients in the 5Fr stent group, but did occur in 11 of the 133 patients in the 3Fr stent group (P = .0003). CONCLUSIONS: Among patients at high-risk for PEP, the spontaneous dislodgement rate of unflanged, short-length, 5Fr PD stents is significantly higher than for unflanged, long-length, 3Fr stents. This decreases the need for endoscopic removal. A higher rate of PD stent placement failure and PEP was observed in patients with 3Fr stents. To view this article's video abstract, go to the AGA's YouTube Channel.