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Background and Aims: EUS-guided hepaticogastrostomy has been performed for many years with most published experience from outside the United States. The luminal access point can be from the esophagus, stomach, duodenum, or jejunum; biliary access can be either into the right or left intrahepatic system. Thus, we prefer the term EUS-guided transhepatic biliary drainage (ETBD). We describe what is believed to be the largest single-center U.S. experience of ETBD for management of benign and malignant biliary disease., Methods: This was a retrospective study of all ETBD conducted by 1 endoscopist between September 2014 and May 2021., Results: Two hundred fifteen patients underwent attempted ETBD: 85 for benign disease and 130 for malignant disease. Ninety-two patients (43%) had surgically altered anatomy (SAA). In 94 patients previously endoscopic attempts failed. The approach was transesophageal in 9, transgastric in 188, transduodenal in 5, and transjejunal in 5 patients. In 1 patient a bilateral approach was used. Standard fully covered self-expandable stents of 4- to 10-cm lengths and 8- or 10-mm diameters were used. Technical success was 95.3% and clinical success was 87.25%. Forty patients (18.6%) experienced adverse events (13 mild, 21 moderate, and 6 severe according to the modified American Society for Gastrointestinal Endoscopy lexicon). Mean follow-up was 257.31 ± 308.11 days for all patients (124.53 ± 229.86 days for benign disease and 457.27 ± 466.31 days for malignant disease). Seventy-four patients (34.4%) had died at the time of data collection (66 in the malignant cohort, 8 in the benign cohort). Of those with malignancy surviving >6 months, 17.4% required reintervention., Conclusions: ETBD is effective in the management of benign and malignant biliary obstruction for patients with SAA as well as native anatomy, with a modest adverse event rate., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

The implementation of robotic surgery in the field of hepato-pancreato-biliary (HPB) has been a slow but significant process. HPB procedures offer a unique challenge when for new technologies, as the surgeries themselves are complex, with long learning curves. Yet the benefits of the robotic approach for this patient population are notable: decreased length of stay, blood loss, postoperative complications, and improving quality of life. The use of robotic simulation focused curriculum plays a crucial role in mentoring experienced surgeons and surgical trainees. Although further study remains, early studies suggest a structured simulation curriculum decreases time, technical errors, and improves proficiency, ultimately leading to a more expedited and safe implementation of robotic techniques in the HPB field.

Background: Chemotherapy is frequently used in cholangiocarcinoma as an adjunct to surgical resection, but the appropriate sequence of chemotherapy with surgery is unclear., Patients and Methods: Using the National Cancer Database, we identified patients who underwent surgery and chemotherapy for stage I-III cholangiocarcinoma between 2006 and 2014. The propensity score reflecting the probability of receiving neoadjuvant chemotherapy was estimated by multivariate logistic regression method. Patients in the neoadjuvant and adjuvant chemotherapy study arms were then propensity-matched in 1:3 ratios using the nearest neighbor method. Overall Survival (OS) in the matched data set was estimated using the Kaplan-Meier method. Hazard ratios (HRs) were calculated using Cox proportional hazard regression model., Results: Of the 1450 patients who met our inclusion criteria, 299 (20.6%) received neoadjuvant chemotherapy while 1151 (79.3%) received adjuvant chemotherapy. The median age at diagnosis was 63 years. 278 patients in the neoadjuvant group were matched to 700 patients in the adjuvant group. In the matched cohort, patients who received neoadjuvant chemotherapy had a superior OS compared to those who received adjuvant chemotherapy (Median OS: 40.3 vs. 32.8 months; HR: 0.78; 95% CI: 0.64-0.94, p = 0.01). The 1- and 5-year OS rates for the neoadjuvant chemotherapy group were 85.8% and 42.5% respectively compared to 84.6% and 31.7% for the adjuvant chemotherapy group., Conclusion: In this large national database study, neoadjuvant chemotherapy was associated with a longer OS in a select group of patients with cholangiocarcinoma compared to those who underwent upfront surgical resection followed by adjuvant chemotherapy., (Copyright © 2019 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Background and Study Aims: Preoperative biliary drainage is often initiated with endoscopic retrograde cholangiopancreatography (ERCP) in patients with potentially resectable perihilar cholangiocarcinoma (PHC), but additional percutaneous transhepatic catheter (PTC) drainage is frequently required. This study aimed to develop and validate a prediction model to identify patients with a high risk of inadequate ERCP drainage., Patients and Methods: Patients with potentially resectable PHC and (attempted) preoperative ERCP drainage were included from two specialty center cohorts between 2001 and 2013. Indications for additional PTC drainage were failure to place an endoscopic stent, failure to relieve jaundice, cholangitis, or insufficient drainage of the future liver remnant. A prediction model was derived from the European cohort and externally validated in the USA cohort., Results: Of the 288 patients, 108 (38%) required additional preoperative PTC drainage after inadequate ERCP drainage. Independent risk factors for additional PTC drainage were proximal biliary obstruction on preoperative imaging (Bismuth 3 or 4) and predrainage total bilirubin level. The prediction model identified three subgroups: patients with low risk (7%), moderate risk (40%), and high risk (62%). The high-risk group consisted of patients with a total bilirubin level above 150 µmol/L and Bismuth 3a or 4 tumors, who typically require preoperative drainage of the angulated left bile ducts. The prediction model had good discrimination (area under the curve 0.74) and adequate calibration in the external validation cohort., Conclusions: Selected patients with potentially resectable PHC have a high risk (62%) of inadequate preoperative ERCP drainage requiring additional PTC drainage. These patients might do better with initial PTC drainage instead of ERCP., (© Georg Thieme Verlag KG Stuttgart · New York.)

Objective: Double-balloon enteroscopy-assisted endoscopic retrograde cholangiopancreaticography (DBE-ERCP) is an effective method for interventions in the pancreaticobiliary system in the post-surgical patient. However, use of currently available endoscopic accessories during this procedure is limited due of the length of the conventional instrument (200 cm). The aim of this study was to explore the utility of the short DBE (152 cm) for the management of pancreaticobiliary disorders in patients with surgically altered anatomies., Methods: Data were collected retrospectively on patients with various anatomic variations in whom ERCP was performed using the short DBE from April 2008 to November 2011. Basic demographic information, clinical presentation, preoperative imaging, and type of surgery, procedural technical success rate, and adverse events were evaluated. Descriptive analysis was used to document the demographic and clinical data of the patients., Results: We identified 79 patients in whom DBE-ERCP was attempted (38 % male, mean age 58 years). Indications for the procedure were removal of a previously placed stent (n = 5), suspected sphincter of Oddi dysfunction type 1 (n = 3), surgical biliary leak (n = 3), pancreatic anastomotic stricture (n = 2), suspected biliary stones (n = 48), and biliary strictures visualized on imaging (n = 18). Overall, the success rate of DBE-ERCP in all patients was 81 % (64/79). The scope could not reach the papilla or surgical anastomosis in 8 cases and duct cannulation failed in 7 cases. The following interventions were performed: biliary sphincterotomy (n = 39), dilation of CBD stenosis with a balloon (n = 30), biliary stent insertion (n = 25), stone removal (n = 35), brushing cytology of biliary strictures (n = 3), and stent retrieval (n = 4). Three patients developed post-procedure pancreatitis. There was 1 episode of self-limited bleeding., Conclusions: The current study demonstrates that DBE assisted ERCP for pancreaticobiliary interventions using a short enteroscope are feasible in patients with surgically altered anatomy.

Introduction: Surgeon specialization has been shown to result in improved outcomes but may not be the sole measure of surgical quality in hepato-pancreatico-biliary (HPB) surgery. We attempted to determine which factors predominate in optimal patient outcomes between volume, surgeon, and hospital resources., Methods: All non-transplant pancreatic (n = 7195) and liver operations (n = 4809) from the Nationwide Inpatient Sample (NIS) were examined from 1998-2005. Surgeons and hospitals were divided into two groups, transplant (TX) or non-transplant (non-TX), using the unique surgeon and hospital identifier of NIS. A logistic regression model examined the relationship between factors while accounting for patient and hospital factors., Results: We identified 4,355 primary surgeons (165 TX, 4,190 non-TX) who performed HPB surgery in 675 hospitals across 12 different states. Non-TX surgeons performed the majority of pancreatic (97%) and liver procedures (81%). There was no difference in mortality after HPB surgery depending on surgeon specialty (p = 0.59). Factors for inpatient death after HPB surgery included increasing age, male gender, and public insurance (p < 0.05). In addition, surgery performed at a TX center had a 21% lower odds of perioperative mortality., Discussion: Non-TX surgeons performed the majority of pancreatic and liver surgery in the US. Hospital factors like support of transplantation but not surgical specialty, appeared to impact operative mortality. Future regulatory benchmarks should consider these types of center-based facilities and resources to assess patient outcomes.

It is apparent that no inherent dilemma exists in training surgeons in both open and laparoscopic techniques. The important point is that surgeons are trained: a solid foundation in the basic sciences, well-developed technical skills, a large clinical experience on which to base future decisions, and the insight to know when one's skills require improvement. The principles of biliary surgery should be adhered to, and in one's haste to become proficient at laparoscopic techniques, one must not abandon the most basic of these-the unequivocal identification of all structures before ligating, dividing, clipping, or otherwise sacrificing tissues.

Medical devices marketed in the United States must satisfy FDA standards of safety and effectiveness. Many observers have criticized the FDA medical device review process as both time consuming and unpredictable. In this note, Lawrence Makow examines the Agency's treatment of two novel medical technologies, magnetic resonance spectroscopy and biliary extracorporeal shockwave lithotripsy. He concludes that the outcomes of these cases exemplify the mismatch between clinical utility and FDA approval status that has prompted concerns about lack of predictability. Mr. Makow asserts that this mismatch results from the FDA's implementation of the medical device statute rather than from the statute itself. He proposes an asymmetric standard for evaluating the safety and efficacy of new medical devices. While the safety showing would always require a high burden of proof, the efficacy standard would vary depending on the relationship between the device's safety and efficacy. Under this asymmetric standard, the FDA could better manage its workload and achieve more predictable results without sacrificing the public interest in avoiding injury from unproven medical devices.