Clinical predictors of significant findings on EUS for the evaluation of incidental common bile duct dilation.

BACKGROUND AND AIMS: While endoscopic ultrasound(EUS) is highly accurate for the evaluation of common bile duct (CBD) dilation, the yield of EUS in patients with incidental CBD dilation is unclear. METHODS: Serial patients undergoing EUS for incidental, dilated CBD (per radiologist, minimum >6mm objectively) from two academic medical centers, without active pancreaticobiliary disease or significantly elevated LFTs were evaluated. Multivariable logistic regression identified predictors of EUS with significant findings and a novel prediction model was derived from one center, internally validated with bootstrapping, and externally validated at the second center. RESULTS: Of 375 patients evaluated, 31 (8.3%) had significant findings including 26 choledocholithiasis, 1 ampullary adenoma, and 1 pancreatic mass. Predictors of significant findings with EUS included: age ≥70(OR 3.7, 95CI 1.5-10.0), non-biliary-type abdominal pain without chronic pain(OR 6.1, 95CI 2.3-17.3), CBD diameter ≥15 mm or ≥17mm with cholecystectomy(OR 6.9, 95CI 2.7-18.7), and prior ERCP(OR 6.8, 95CI 2.1-22.5). A point-based novel clinical prediction model was created: age ≥70=1, non-biliary-type abdominal pain without chronic pain=2, prior ERCP=2, CBD dilation=2. A score <1 had 93% (development) and 100% (validation) sensitivity and predicted a <2% chance of having a significant finding in both cohorts while excluding the need for EUS in ∼30% of both cohorts. Conversely, a score >4 was >90% specific for the presence of significant pathology. CONCLUSION: Less than 10% of patients undergoing EUS for incidental CBD dilation had pathologic findings. This novel, externally validated, clinical prediction model may reduce low-yield, invasive evaluation in nearly a third of patients.

Obesity and Risk for Incomplete Stone Clearance in Patients with Bile Duct Stones Undergoing ERCP.

INTRODUCTION: Obesity degrades fluoroscopic image quality and could impact on the endoscopic retrograde cholangiopancreatography (ERCP) outcomes. Our study aimed to compare the clinical outcomes and adverse events (AEs) between obese and non-obese patients undergoing ERCP for biliary stone-related conditions. METHODS: Patients who underwent ERCP for biliary-stone related conditions were included. The analyzed outcomes included the rates of successful bile duct cannulation, incomplete bile duct stone clearance, recurrent bile duct stones, and AEs. RESULTS: A total of 229 patients (116 obese patients and 113 non-obese patients) were included. All patients had successful bile duct cannulation. The rates of incomplete bile duct stone clearance (11.3% vs. 9.0%, P = 0.51), recurrent bile duct stones (1.9% vs. 4.2%, P = 0.24), and AEs (1.8% vs. 0.7%, P = 0.43) were not significantly different between the two groups, respectively. CONCLUSION: Our study demonstrates no associations between obesity and the rates of incomplete stone clearance, recurrent stones, successful cannulation, or AEs in patients undergoing ERCP for biliary stone-related disease.

Endoscopic retrograde cholangiopancreatography (ERCP) approach for patients with Roux-en-Y gastric bypass: a comparative study between four ERCP techniques with proposed management algorithm.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is technically challenging in patients with Roux-en-Y gastric bypass (RYGB) due to altered anatomy. OBJECTIVE: To compare the procedural and clinical outcomes of 4 different ERCP techniques in RYGB patients. SETTING: Academic tertiary referral center in the United States. METHODS: A retrospective cohort study including patients with RYGB anatomy who underwent an ERCP between January 2015 and September 2020. We compared procedural success and adverse events (AEs) rates of balloon-assisted enteroscopy (BAE), gastrostomy-assisted ERCP (GAE), endoscopic ultrasound (EUS)-directed transgastric ERCP (EDGE), and rendezvous guidewire-assisted ERCP (RGA). RESULTS: Seventy-eight RYGB patients underwent a total of 132 ERCPs. The mean age was 60 ± 11.8 years, with female predominance (85.7%). The ERCP procedures performed were BAE (n = 64; 48.5%), GAE (n = 18; 13.7%), EDGE (n = 25; 18.9%), and RGA (n = 25; 18.9%), with overall procedure success rates of 64.1%, 100%, 89.5%, and 91.7%, respectively. All approaches were superior to BAE (GAE versus BAE, P = .003; EDGE versus BAE, P = .034; RGA versus BAE, P = .011). The overall AE rates were 10.9%, 11.1%, 15.8 %, and 25.0%, respectively. There was no statistical difference in AEs. There were also no differences in bleeding, post-ERCP pancreatitis, and perforation rates between the 4 approaches. CONCLUSION: Procedure success was similar between GAE, RGA, and EDGE, but superior to BAE. AE rates were similar between approaches.

Tips and tricks for endoscopic transpapillary gallbladder drainage.

Background and Aims: Percutaneous gallbladder drainage has traditionally been the reference standard treatment for cholecystitis in patients deemed unfit for surgery. Endoscopic transpapillary gallbladder drainage has emerged as a reliable alternative that offers an internal, incisionless option in nonsurgical patients. The aim of this study was to describe techniques for successful selective cystic duct cannulation and gallbladder drainage during ERCP. Methods: A series of endoscopic transpapillary gallbladder procedures is shown, including endoscopic and fluoroscopic video and images. Each case highlights best practices, devices, and techniques to aid with successful completion of challenging cases. Results: Standard cystic duct cannulation and gallbladder access is described using a standard catheter and a 0.035-inch angled guidewire. Challenges to selective cystic duct cannulation are overcome using various approaches, including using a rotatable catheter system, downsizing to a smaller guidewire, occluding the proximal common hepatic duct with an occlusion balloon, and directly intubating the cystic duct using peroral cholangioscopy. Dilation of the cystic duct is performed using standard devices designed for biliary intervention, but smaller, percutaneous angioplasty balloons are used for small ducts and severe strictures. After dilation, a plastic, double-pigtail stent is deployed across the papilla, and access is reobtained in a similar fashion to place a second, parallel stent. To eliminate the need to re-access the gallbladder after initial stent deployment, a cytology brush catheter is repurposed to obtain dual-wire access within the gallbladder before initial stent deployment. Conclusions: When the fundamentals of ERCP and the techniques described here are used, endoscopic transpapillary gallbladder drainage can be performed safely and effectively to treat cholecystitis in patients who are not surgical candidates.

Risk of post-sphincterotomy bleeding in patients with thrombocytopenia.

Background: Reports suggest that the rate of adverse events (AEs) post-endoscopic sphincterotomy (ES) to be as high as 10%, with gastrointestinal bleeding being most common after post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. Objective: The aim of this study was to characterize the incidence of bleeding in patients with thrombocytopenia following ES. Design: Retrospective observational cohort study. Methods: Patients with thrombocytopenia (defined as <150,000 platelets/µL) who underwent ES between May 2017 and December 2020 were identified at a tertiary care medical center. The incidence of immediate (intraprocedural oozing >5 min or requiring intervention) or delayed (clinical bleeding with associated hemoglobin drop within 14 days) post-ES bleeding was determined via manual chart review. Results: A total of 221 patients with a mean platelet count of 108,000 ± 13,000 platelets/µL underwent ERCP with ES. Immediate bleeding occurred in 11 (5%) patients with no significant drop in hemoglobin or transfusion requirement. Two patients (0.9%), both of whom were noted to have immediate bleeding, also developed delayed bleeding. Presence of malignancy was associated with an increased risk of bleeding (36.4% versus 11.4%, p = 0.037) while platelet count was not. Conclusion: In a cohort of patients with thrombocytopenia, rates of immediate and delayed bleeding are similar to previously reported AE rates of ES in the general patient population. Careful attention should be given to patients with a history of active malignancy as well as those who develop immediate bleeding as they appear to be at increased risk for bleeding complications.

Risk of bleeding in patients with low platelet counts after sphincterotomy during endoscopic retrograde cholangiopancreatography procedures The sphincter that controls the flow of bile into the small bowel is often cut for a variety of clinical indications (sphincterotomy) during a procedure called endoscopic retrograde cholangiopancreatography (ERCP). One of the complications of this maneuver is bleeding. The physiology of bleeding is complex, and the risk of bleeding cannot be well captured by a single condition or laboratory test. It was presumed that low platelet counts would increase a patient's risk of bleeding during a procedure, but emerging data suggests that many endoscopic procedures are safer than previously understood in these patients. However, there is limited data for sphincterotomy and ERCP. This study from a single, academic center evaluates the outcomes of all patients who underwent sphincterotomy with platelets that were below the normal threshold. Overall, the data shows that sphincterotomy appears to be as safe in patients with low platelets as the general population. Patients with active cancer may be at slightly higher risk for bleeding. Additional precautions may be needed in this group, however further studies are needed to confirm this finding.

The spearfishing sign: differentiating mucin from mural nodules in pancreatic cysts.

Video 1EUS evaluation of intracystic mucin and demonstration of spearfishing sign.

Endoscopic ultrasound-guided versus percutaneous drainage for the management of post-operative fluid collections after distal pancreatectomy.

BACKGROUND: Post-operative pancreatic fluid collections (POPFCs) can be drained using percutaneous or endoscopic approaches. The primary aim of this study was to compare rates of clinical success between endoscopic ultrasound-guided drainage (EUSD) with percutaneous drainage (PTD) in the management of symptomatic POPFCs after distal pancreatectomy. Secondary outcomes included technical success, total number of interventions, time to resolution, rates of adverse events (AEs), and POPFC recurrence. METHODS: Adults who underwent distal pancreatectomy from January 2012 to August 2021 and developed symptomatic POPFC in the resection bed were retrospectively identified from a single academic center database. Demographic data, procedural data, and clinical outcomes were abstracted. Clinical success was defined as symptomatic improvement and radiographic resolution without requiring an alternate drainage modality. Quantitative variables were compared using a two-tailed t-test and categorical data were compared using Chi-squared or Fisher's exact tests. RESULTS: Of 1046 patients that underwent distal pancreatectomy, 217 met study inclusion criteria (median age 60 years, 51.2% female), of whom 106 underwent EUSD and 111 PTD. There were no significant differences in baseline pathology and POPFC size. PTD was generally performed earlier after surgery (10 vs. 27 days; p < 0.001) and more commonly in the inpatient setting (82.9% vs. 49.1%; p < 0.001). EUSD was associated with a significantly higher rate of clinical success (92.5% vs. 76.6%; p = 0.001), fewer median number of interventions (2 vs. 4; p < 0.001), and lower rate of POPFC recurrence (7.6% vs. 20.7%; p = 0.007). AEs were similar between EUSD (10.4%) and PTD (6.3%, p = 0.28), with approximately one-third of EUSD AEs due to stent migration. CONCLUSION: In patients with POPFCs after distal pancreatectomy, delayed drainage with EUSD was associated with higher rates of clinical success, fewer interventions, and lower rates of recurrence than earlier drainage with PTD.

Uncovered versus fully covered self-expandable metal stents for the management of distal malignant biliary obstruction.

BACKGROUND AND AIM: Self-expandable metal stents (SEMSs) are widely used for palliation of distal malignant biliary obstruction (dMBO). However, previous studies comparing the outcomes between uncovered SEMSs (UCSEMSs) and fully covered SEMSs (FCSEMSs) report conflicting results. This large cohort study aimed to compare the clinical outcomes between UCSEMSs and FCSEMSs for dMBO. METHODS: A retrospective cohort study was performed in patients with dMBO who underwent either UCSEMS or FCSEMS placement between May 2017 and May 2021. Primary outcomes were rates of clinical success, adverse events (AEs), and unplanned endoscopic reintervention. Secondary outcomes were types of AEs, intervention-free stent patency, and management and outcomes of stent occlusion. RESULTS: The cohort included 454 patients (364 in the UCSEMS group and 90 in the FCSEMS group). Median follow-up duration was 9.6 months and was similar between the 2 groups. Use of UCSEMSs and FCSEMSs had comparable clinical success (P = .250). However, use of UCSEMSs had significantly higher rates of AEs (33.5% vs 21.1%; P = .023) and unplanned endoscopic reintervention (27.0% vs 11.1%; P = .002). UCSEMSs had a higher rate of stent occlusion (26.9% vs 8.9%; P < .001) and shorter median time to stent occlusion (4.4 months vs 10.7 months; P = .002). Stent reintervention-free survival was higher in the FCSEMS group. FCSEMSs had a significantly higher rate of stent migration (7.8% vs 1.1%; P < .001), but patients in the FCSEMS group had similar rates of cholecystitis (.3% vs 1.1%; P = .872) and post-ERCP pancreatitis (6.3% vs 6.6%; P = .90). When UCSEMSs did occlude, placement of a coaxial plastic stent had a higher rate of stent reocclusion compared with coaxial SEMS placement (46.7% vs 19.7%; P = .007). CONCLUSION: FCSEMSs should be considered for the palliation of dMBO because of lower rates of AEs, longer patency rates, and lower rates of unplanned endoscopic intervention.

Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial.

OBJECTIVE: We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection. SUMMARY BACKGROUND DATA: Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON. DESIGN: We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound -guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥6 cm in diameter with >30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events. RESULTS: Forty consecutive patients were enrolled September 2018 to March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. Serious adverse events occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths. CONCLUSIONS: Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.-gov no: NCT03525808.

Identification of patients with malignant biliary strictures using a cholangioscopy-based deep learning artificial intelligence (with video).

BACKGROUND AND AIMS: Accurately diagnosing malignant biliary strictures (MBSs) as benign or malignant remains challenging. It has been suggested that direct visualization and interpretation of cholangioscopy images provide greater accuracy for stricture classification than current sampling techniques (ie, brush cytology and forceps biopsy sampling) using ERCP. We aimed to develop a convolutional neural network (CNN) model capable of accurate stricture classification and real-time evaluation based solely on cholangioscopy image analysis. METHODS: Consecutive patients with cholangioscopy examinations from 2012 to 2021 were reviewed. A CNN was developed and tested using cholangioscopy images with direct expert annotations. The CNN was then applied to a multicenter, reserved test set of cholangioscopy videos. CNN performance was then directly compared with that of ERCP sampling techniques. Occlusion block heatmap analyses were used to evaluate and rank cholangioscopy features associated with MBSs. RESULTS: One hundred fifty-four patients with available cholangioscopy examinations were included in the study. The final image database comprised 2,388,439 still images. The CNN demonstrated good performance when tasked with mimicking expert annotations of high-quality malignant images (area under the receiver-operating characteristic curve, .941). Overall accuracy of CNN-based video analysis (.906) was significantly greater than that of brush cytology (.625, P = .04) or forceps biopsy sampling (.609, P = .03). Occlusion block heatmap analysis demonstrated that the most frequent image feature for an MBS was the presence of frond-like mucosa/papillary projections. CONCLUSIONS: This study demonstrates that a CNN developed using cholangioscopy data alone has greater accuracy for biliary stricture classification than traditional ERCP-based sampling techniques.

Case presentation of 8-year follow up of recurrent malignant duodenal Insulinoma and lymph node metastases and literature review of malignant Insulinoma management.

BACKGROUND: Insulinoma is an uncommon insulin-secreting neuroendocrine tumor that presents with severe recurrent hypoglycemia. Although cases of extrapancreatic insulinomas have been reported, the majority of insulinomas occur in the pancreas. The number of reported cases of ectopic insulinomas with follow-up assessments is limited and they do not report disease recurrence. The current report presents the first documented case of recurrent extrapancreatic insulinoma with 8 years of follow-up, provides relevant literature review, and proposes surveillance and treatment strategies. CASE PRESENTATION: We describe an insulinoma localized in the duodenal wall of a 36-year-old female who presented in 2013 with weight gain and Whipple's triad and was successfully managed with duodenotomy and enucleation. She presented again in 2017 with recurrent Whipple's triad and was found to have metastatic disease localized exclusively to peripancreatic lymph nodes. Primary pancreatic insulinoma was not evident and her hypoglycemia resolved following lymph node dissection. Eight years after initial presentation continuous glucose monitoring (CGM) showed a trend for euglycemia, and PET-CT Gallium 68 DOTATATE scan evaluation indicated absence of recurrent disease. CONCLUSION: Insulinomas are rare clinical entities and extrapancreatic insulinomas are particularly uncommon. Follow-up evaluation and treatment strategies for ectopic insulinoma recurrence presents a significant clinical challenge as the condition has hitherto remained undescribed in the literature. Available evidence in the literature indicates that lymph node metastases of intrapancreatic insulinomas likely do not change prognosis. Given the absence of long-term data informing the management and monitoring of patients with extrapancreatic insulinoma, we suggest patient education for hypoglycemic symptoms, monitoring for hypoglycemia with CGM, annual imaging, and a discussion with patients regarding treatment with octreotide or alternative somatostatin receptor analog therapies.

Endo-anesthesia: a primer.

Gastrointestinal (GI) endoscopy has witnessed a Cambrian explosion of techniques, indications, and expanding target populations. GI endoscopy encompasses traditional domains that include preventive measures, palliation, as alternative therapies in patients with prohibitive risks of more invasive procedures, and indicated primary treatments. But, it has expanded to include therapeutic and diagnostic interventional endosonography, luminal endoscopic resection, third space endotherapy, endohepatology, and endobariatrics. The lines between surgery and endoscopy are blurred on many occasions within this paradigm. Moreover, patients with high degrees of co-morbidity and complex physiology require more nuanced peri-endoscopic management. The rising demand for endoscopy services has resulted in the development of endoscopy referral centers that offer these invasive procedures as directly booked referrals for regional and rural patients. This further necessitates specialized programs to ensure appropriate evaluation, risk stratification, and optimization for safe sedation and general anesthesia if needed. This landscape is conducive to the organic evolution of endo-anesthesia to meet the needs of these focused and evolving practices. In this primer, we delineate important aspects of endo-anesthesia care and provide relevant clinical and logistical considerations pertaining to the breadth of procedures.

Histological assessment of new cholangioscopy-guided forceps in ERCP biliary stricture sampling: a blinded comparative study.

Background and study aims Obtaining quality tissue during ERCP biliary stricture sampling is of paramount importance for a timely diagnosis. While single-operator cholangioscopy (SOC)-guided biopsies have been suggested to be the superior biliary tissue acquisition modality given direct tissue visualization, less is known about the specimen histological quality. We aimed to analyze the specimen quality of SOC biopsies and compare the new generation forceps with prior "legacy" forceps. Patients and methods Patients who underwent SOC from January 2017-August 2021 for biliary sampling were reviewed. In February 2020, the SOC-guided biopsy forceps were changed from legacy SpyBite to the SpyBite Max forceps (max). Specimens were assessed by blinded pathologists for crush artifact (none, mild, or severe) and gross size (greatest dimension in mm). Crush artifact and gross size were compared between the two groups. The diagnostic performance characteristics for cholangiocarcinoma (CCA), were assessed in an exploratory fashion. Results Eighty-one patients (max = 27, legacy = 54) with similar baseline characteristics were included in this study. On blinded pathological assessment, 58 % had crush artifact, without significant differences between the two groups (Max 63 % vs. Legacy 56 %; P  = 0.64). A similar mean specimen size was found (max 3 mm vs. legacy 3.2 mm; P  = 0.24). The overall prevalence of CCA was 40 %. The sensitivity, specificity, positive predictive value, and negative predictive value of the entire cohort using a combination of cytology, fluorescence in situ hybridization, and SOC-guided biopsies were 78.1 %, 91.8 %, 86.2 %, and 86.5 %, respectively. No difference between legacy or max groups was found. Conclusions A high rate of crush artifact was found in SOC-guided biopsy specimens. Further investigation regarding proper biopsy technique and handling is necessary to increase the diagnostic yield with SOC-guided biopsies.

Endoscopic ultrasound-guided injectable therapy for pancreatic cancer: A systematic review.

BACKGROUND: Given the low survival rate in pancreatic cancer, new therapeutic techniques have been explored, especially for unresectable or borderline resectable disease. Endoscopic ultrasound (EUS) provides real-time imaging and minimally invasive access for local and targeted injection of anti-tumor agents directly into the pancreatic tumor. Limited studies have been reported using this technique for the treatment of pancreatic ductal adenocarcinoma (PDAC). AIM: To evaluate the progress made with EUS-guided injectable therapies in the treatment of PDAC. METHODS: All original articles published in English until July 15, 2021, were retrieved via a library-assisted literature search from Ovid Evidence-Based Medicine Reviews and Scopus databases. Reference lists were reviewed to identify additional relevant articles. Prospective clinical studies evaluating the use of EUS-guided injectable therapies in PDAC were included. Studies primarily directed at non-EUS injectable therapies and other malignancies were excluded. Retrieved manuscripts were reviewed descriptively with on critical appraisal of published studies based on their methods and outcome measures such as safety, feasibility, and effectiveness in terms of tumor response and survival. Heterogeneity in data outcomes and therapeutic techniques limited the ability to perform comparative statistical analysis. RESULTS: A total of thirteen articles (503 patients) were found eligible for inclusion. The EUS-injectable therapies used were heterogeneous among the studies consisting of immunotherapy (n = 5) in 59 patients, chemotherapy (n = 1) in 36 patients, and viral and other biological therapies (n = 7) in 408 patients. Eleven of the studies reviewed were single armed while two were double armed with one randomized trial and one non-randomized comparative study. Overall, the included studies demonstrated EUS-guided injectable therapies to be safe and feasible with different agents as monotherapy or in conjunction with other modalities. Promising results were also observed regarding their efficacy and survival parameters in patients with PDAC. CONCLUSION: EUS-guided injectable therapies, including immunotherapy, chemotherapy, and viral or other biological therapies have shown minimal adverse events and potential efficacy in the treatment of PDAC. Comparative studies, including controlled trials, are required to confirm these results in order to offer novel EUS-based treatment options for patients with PDAC.

Efficacy and safety of endoscopic ultrasound-guided gastrojejunostomy in patients with malignant gastric outlet obstruction and ascites.

Background and study aims Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is an endoscopic procedure for treating gastric outlet obstruction (GOO). Limited data exist regarding the safety and efficacy of EUS-GJ in patients with malignant GOO with ascites. Thus, we aimed to study the outcomes and safety of EUS-GJ in GOO patients with vs. without ascites. Patients and methods This is a retrospective cohort study of patients with malignant GOO who underwent successful EUS-GJ at a tertiary care academic center. Primary outcomes included the efficacy and safety of EUS-GJ. Secondary outcomes included 30-day readmission, reintervention, and survival utilizing Kaplan-Meier analysis. Results A total of 55 patients (mean age of 67.0 ±â€Š11.3 years, 40.0 % female) who underwent EUS-GJ, of whom 24 had ascites (small in 22, large in 2) were included. Clinical success was achieved in 91.7 % and 93.5 % ( P =  1.00) of patients with and without ascites, respectively. A higher rate of adverse events (AEs) was noted in patients with ascites but this was not statistically significant (37.5 % vs. 19.4 %, P =  0.13). Four patients in the ascites group (16.6 %) developed clinical evidence of peritonitis or sepsis post-EUS-GJ. Eight patients with ascites developed worsening ascites within a month of EUS-GJ. In contrast, only one patient without ascites developed evidence of new ascites. The median survival of patients was not significantly different between the two groups (patients with ascites: 129 days vs. patients without ascites: 180 days, ( P =  0.12). Conclusions The efficacy EUS-GJ in the presence of ascites is promising; however, the safety profile remains concerning given the high rate of AEs, specifically peritonitis and sepsis.

Potential Role of Inflammation-Promoting Biliary Microbiome in Primary Sclerosing Cholangitis and Cholangiocarcinoma.

BACKGROUND: Primary sclerosing cholangitis (PSC) is a major risk factor for cholangiocarcinoma (CCA). We investigated biliary and fecal microbiota to determine whether specific microbes in the bile or stool are associated with PSC or CCA. METHODS: Bile was obtained from 32 patients with PSC, 23 with CCA with PSC, 26 with CCA without PSC, and 17 controls. Over 90% of bile samples were from patients with perihilar CCA. Stool was obtained from 31 patients with PSC (11 were matched to bile), 16 with CCA with PSC (10 matched to bile), and 11 with CCA without PSC (6 matched to bile). Microbiota composition was assessed using 16SrRNA-marker-based sequencing and was compared between groups. RESULTS: Bile has a unique microbiota distinguished from negative DNA controls and stool. Increased species richness and abundance of Fusobacteria correlated with duration of PSC and characterized the biliary microbiota in CCA. Stool microbiota composition showed no significant differences between groups. CONCLUSIONS: We identified a unique microbial signature in the bile of patients with increased duration of PSC or with CCA, suggesting a role for microbiota-driven inflammation in the pathogenesis and or progression to perihilar CCA. Further studies are needed to test this hypothesis.

Prospective Study Assessing Impact of Ethylene Oxide Sterilization on Endoscopic Ultrasound Image Quality.

BACKGROUND & AIMS: Duodenoscope-associated transmission of infections has raised questions about efficacy of endoscope reprocessing using high-level disinfection (HLD). Although ethylene oxide (ETO) gas sterilization is effective in eradicating microbes, the impact of ETO on endoscopic ultrasound (EUS) imaging equipment remains unknown. In this study, we aimed to compare the changes in EUS image quality associated with HLD vs HLD followed by ETO sterilization. METHODS: Four new EUS instruments were assigned to 2 groups: Group 1 (HLD) and Group 2 (HLD + ETO). The echoendoscopes were assessed at baseline, monthly for 6 months, and once every 3 to 4 months thereafter, for a total of 12 time points. At each time point, review of EUS video and still image quality was performed by an expert panel of reviewers along with phantom-based objective testing. Linear mixed effects models were used to assess whether the modality of reprocessing impacted image and video quality. RESULTS: For clinical testing, mixed linear models showed minimal quantitative differences in linear analog score (P = .04; estimated change, 3.12; scale, 0-100) and overall image quality value (P = .007; estimated change, -0.12; scale, 1-5) favoring ETO but not for rank value (P = .06). On phantom testing, maximum depth of penetration was lower for ETO endoscopes (P < .001; change in depth, 0.49 cm). CONCLUSIONS: In this prospective study, expert review and phantom-based testing demonstrated minimal differences in image quality between echoendoscopes reprocessed using HLD vs ETO + HLD over 2 years of clinical use. Further studies are warranted to assess the long-term clinical impact of these findings. In the interim, these results support use of ETO sterilization of EUS instruments if deemed clinically necessary.

Comparison of EUS-guided choledochoduodenostomy and percutaneous drainage for distal biliary obstruction: A multicenter cohort study.

Background and Objectives: Percutaneous transhepatic biliary drainage (PTBD) and EUS-guided choledochoduodenostomy (EUS-CD) are alternate therapies to endoscopic retrograde cholangiopancreatography with stent placement for biliary decompression. The primary outcome of this study is to compare the technical and clinical success of PTBD to EUS-CD in patients with distal biliary obstruction. Secondary outcomes were adverse events (AEs), need for reintervention, and survival. Methods: A multicenter retrospective cohort study from three different centers was performed. Cox regression was used to compare time to reintervention and survival and logistic regression to compare technical and clinical success and AE rates. Subgroup analysis was performed in patients with malignant biliary obstruction (MBO). Results: A total of 86 patients (58 PTBD and 28 EUS-CD) were included. The two groups were similar with respect to age, gender, and cause of biliary obstruction, with malignancy being the most common etiology (80.2%). EUS-CD utilized lumen-apposing metal stents in 15 patients and self-expandable metal biliary stents in 13 patients. Technical success was similar been EUS-CD (100%) and PTBD (96.6%; P = 0.3). EUS-CD was associated with higher clinical success compared to PTBD (84.6% vs. 62.1%; P = 0.04). There was a trend toward lower rates of AEs with EUS-CD 14.3% versus PTBD 29.3%, odds ratio: 0.40 (95% confidence interval [CI]: 0.12-1.33, P = 0.14). The need for reintervention was significantly lower among patients who underwent EUS-CD (10.7%) compared to PTBD (77.6%) (hazard ratio: 0.07, 95% CI: 0.02-0.24; P < 0.001). A sensitivity analysis of only patients with MBO demonstrated similar rate of reintervention between the groups in individuals who survived 50 days or less after the biliary decompression. However, reintervention rates were lower for EUS-CD in those with longer survival. Conclusion: EUS-CD is a technically and clinically highly successful procedure with a trend toward lower AEs compared to PTBD. EUS-CD minimizes the need for reintervention, which may enhance end-of-life quality in patients with MBO and expected survival longer than 50 days.