EUS-guided Biliary Drainage Research Articles

Sustainable effectiveness of double duodenal and EUS-guided transmural biliary drainage in a patient with metastasis to biliopancreatoduodenal zone

Obstructive jaundice with duodenal obstruction are often encountered in patients with primary cancer or metastasis to bilipancreatoduodenal zone. Usually palliative surgery involving creation of gastroentero and liver-cholecysteneteroanas-tamosis is used. This palliative surgery carries a high risk of complications and death if performed at the height of jaundice. In this case endoscopic stenting of duodenum or EUS-guided transmural biliary drainage may be preferred method of treatment. At the same time in the majority of patients performing of ERCP in cases of duodenum obstruction is not technically feasible. In this case EUS-guided transmural biliary drainage can be implemented. This clinical case demonstrates endoscopic treatment of a patient with pancreatoduodenal cancer complicated by duodenal obstruction and obstructive jaundice using endosonography and x-ray guided endoscopy.

Endoscopic Management of Malignant Biliary Stricture.

A biliary stricture is an area of narrowing in the extrahepatic or intrahepatic biliary system. The majority of biliary strictures are caused by malignancies, particularly cholangiocarcinoma and pancreatic adenocarcinoma. Most malignant biliary strictures are unresectable at diagnosis. Treatment of these diseases historically required surgical procedures, however, the development of endoscopic techniques has provided alternative minimally invasive treatment options to improve patient quality of life and survival with unresectable disease. While endoscopic retrograde cholangiopancreatography with stent placement has been the cornerstone of biliary drainage for decades, cutting edge endoscopic developments, including radiofrequency ablation and endoscopic ultrasound-guided biliary drainage, offer new therapy options to patients that historically have a poor quality of life and a grim prognosis. In this review, we explore the endoscopic techniques that have contributed to revolutionary advancements in the endoscopic management of malignant biliary strictures.

A unique device enabling electrohydraulic lithotripsy with an ultraslim scope for difficult stones after endoscopic ultrasound-guided biliary drainage.

A unique device enabling electrohydraulic lithotripsy with an ultraslim scope for difficult stones after endoscopic ultrasound-guided biliary drainage.

Application and Value of Endoscopic Ultrasonography Guided Biliary Interventional Therapy in Patients With Biliary Obstruction and Surgically Altered Anatomy.

The aim of this study was to evaluate the efficacy and safety of endoscopic ultrasound-guided biliary drainage (EUS-BD) in patients with biliary obstruction and surgically altered anatomy. This was a retrospective study. We collected data from 60 patients with biliary obstruction and surgically altered anatomies who undergone EUS-BD (group A, 33 cases) and percutaneous transhepatic biliary drainage (PTBD) (group B, 27 cases) after unsuccessful endoscopic retrograde cholangiopancreatography from January 2016 to January 2018. The operation success rate, the clinical success rate, complications, hospital stay were observed. In group A, 31 cases of 33 patients were successfully operated and placed stents or drainage tube by endoscopic ultrasound puncture [endoscopic ultrasonography (EUS) guided rendezvous 8, EUS-guided hepaticogastrostomy 14, EUS-guided choledochoduodenostomy 11], 28 had a significant decrease in jaundice. The complications rate was 9.1% (biliary bleeding 2; acute cholangitis 1). There was statistically significant difference in the complications [9.09% (3/33) vs. 33.33% (9/27), χ=5.45, P<0.05] and length of hospital stay (14.45±5.78 vs. 18.52±8.64 d, t=10.03, P<0.01) between group A and group B. There was not statistical significance in the technical and clinical success rate between 2 groups [93.94% (31/33) vs. 92.60% (25/27), 84.85% (28/33) vs. 85.19% (23/27), χ1=0.10, χ2=0.11, P>0.05]. EUS-BD may be the first choice for patients with biliary obstruction and surgically altered anatomy after a failed endoscopic retrograde cholangiography in centers with expertise in EUS-BD procedures.

Su1262 A FEASIBILITY AND SAFETY OF EUS-GUIDED HEPATICOESOPHAGOSTOMY AS A TRANSESOPHAGEAL EUS-BD

EUS-guided biliary drainage (EUS-BD) has been developed as an alternative biliary drainage after failed ERCP. Bile duct segment 3 (B3) (transgastric route) is a preferred drainage route over bile duct segment 2 (B2) in safety because B2 puncture via transesophageal route has been associated with severe adverse events such as mediastinitis or pneumomediastinum in some case reports. There has been no sufficient data of describing clinical performance of EUS guided transesophageal drainage. We puncture the bile duct segment 2 (B2), intraabdominal transesophageal route under crus of the diaphragm on EUS in performing B2 puncture EUS-BD. We conducted a retrospective analysis of efficacy and safety of EUS-HES (transesophageal route) in comparing with EUS-HGS (transgastric route). Patients who underwent EUS-BD from April 2015 to November 2019 were investigated retrospectively. Technical success rates were 100%[17/17] in the EUS-HES and 96.4%(81/84) in the EUS-HGS. The rate of puncture of B2 were significantly high in the EUS-HES compared with EUS-HGS (B2 88.2% [15/17] vs. B3 11.7%[2/17] in the EUS-HES, and B2 46[38/81]vs. B3 [42/81]vs B6[1/81], P=0.009). The incidence of severe procedural adverse events showed no statistical difference between the EUS-HES and the EUS-HGS (5.8% [1/17] in the EUS-HES vs. 4.9% [4/81] in the EUS-HGS, P=1). Severe procedural adverse event in EUS-HES was peritonitis due to leakage from fistula(n=1), and in HGS were bile leak(n=1) and bleeding(n=3). The median stent patency also showed no statistical difference between in EUS-HES, 113 days (range, 6 to 483 days) and in EUS-HGS, 116 days (range, 0 to 507 days) (P=0.116). EUS-HES showed technically feasible and similar duration of stent patency compared with HGS without severe mediastinal complications.

Sa1420 PHYSICIAN-CONTROLLED GUIDEWIRE INSERTION IMPROVES TECHNICAL SUCCESS RATE OF ENDOSCOPIC ULTRAOUNS=GUIDEDE HEPATICOGSATROSTOMY

Among endoscopic ultrasound-guided biliary drainage (EUS-BD) procedures, EUS-guided hepaticogastrostomy (HGS) might be most complex because of variations in the course of the intrahepatic bile duct compared with the common bile duct or gallbladder. Appropriate guidewire insertion is essential. We recently attempted EUS-HGS using physician-controlled guidewires (PCGW). The present study aimed to determine the technical feasibility and safety of PCGW during EUS-HGS. The present study included 122 consecutive patients who were scheduled to undergo EUS-HGS between October 2017 and April 2019. The primary endpoint was the technical success rate defined as bile duct puncture, guidewire insertion, tract dilation, and metal stent deployment. Guidewire insertion was considered to have failed if an assistant endoscopist was required for manipulation. The intrahepatic bile duct was successfully punctured in 120 of 122 patients. The guidewire was successfully inserted into the biliary tract and manipulated by other endoscopists in 96 patients. We attempted PCGW for the 23 patients in whom the guidewire could not initially be inserted. A guidewire was inserted using PCGW in all 23 of these patients, thus improving the technical success rate of guidewire insertion from 80% to 100%. After tract dilation, we deployed covered metal stent and plastic stents in 117 and two 2 patients, respectively. The overall technical success rate of EUS-HGS was 119 (97.5%) of 122. Adverse events comprising bile peritonitis or leakage developed in five patients. In conclusion, PCGW might contribute to improve the success rate of EUS-HGS.

Su1254 NOVEL TRANSLUMINAL TREATMENT PROTOCOL FOR HEPATICOJEJUNOSTOMY STRICTURE USING COVERED SELF-EXPANDABLE METAL STENT

Hepaticojejunostomy anastomotic stricture (HJS) is a rare complication after pancreatoduodenostomy. However, the rate of HJS may be increased with the expansion of operative indications, such as intraductal papillary mucinous neoplasm. Recently, the indications for EUS-guided biliary drainage to treat benign biliary disease have expanded. Recently, novel transluminal treatment protocol has been established in our hospital. The aim of this study was thus to evaluate the technical feasibility and safety of our treatment protocol. Consecutive patients with complications of HJS between January and April 2019 were enrolled in this study. EUS-guided hepaticogastrostomy (HGS) is firstly performed. After 7 days to create the fistula, HGS stent is removed. HJS is transluminaly evaluated by a cholangioscope, and antegrade balloon dilation is attempted. After 3 months, if HJS is still presence, antegrade stent deployment is performed using a covered metal stent. Also, after 1 month, antegrade stent removal is transluminaly performed. Among total 39 patients, 18 patients were underwent antegrade metal stent deployment. The technical success rate of antegrade stent deployment was 92.9%. Median period of stent placement was 30.5 days (range, 28–38 days), and transluminal stent removal was successfully performed in all patients. During follow-up (median, 278 days; range, 171–505 days), recurrence of HJS was seen in 2 patients. Severe adverse events were not seen in any patients during follow-up period. In conclusion, transluminal stent deployment for HJS under EUS-guidance appears feasible and safe, although further study with a larger sample size and longer follow-up is warranted.

1031 EUS-GUIDED INTRAHEPATIC ACCESS FOR RETROGRADE, ANTEGRADE OR TRANSGASTRIC BILIARY DRAINAGE: INDICATIONS, EFFICACY AND SAFETY FROM AN 8-YEAR TERTIARY CENTRE EXPERIENCE.

Intrahepatic access for EUS-guided biliary drainage (IH-EBD) still lacks convincing evidence on advantages and risks over comparators. Retrospective series are burdened by small size and heterogeneous inclusion of patients and procedures, therefore IH-EBD struggles to find a role in clinical algorithms. We revised the 8-year experience of a tertiary, academic, referral centre. All consecutive IH-EBDs performed between 2012-2019 were retrospectively included. Indications, technical details, clinical/biochemical follow-up and outcomes were extracted from individual patient files. Variables are reported as proportions or median[interquartile range]. χ-squared, Kruskal-Wallis test and Kaplan-Meier curves were used. 104 IH-EBDs were identified [(malignancies=87 (83.7%); failed ERCP=81 (77.9%); post-surgical anatomy=23 (22.1%)]. Distal, hilar and anastomotic strictures represented 50%, 28.9% and 14.4% of indicons. 16 transhepatic ERCP-rendez-vous (RVs), 43 transhepatic antegrade biliary stentings (ASs) and 45 hepatico-gastrostomies (HGs) were identified. Overall technical success was 89.4%, while clinical success (lowering bilirubin or management of choledocholithiasis) was 94%. Using the ASGE lexicon, overall, severe and fatal complication rates were 16.7%, 3.0% and 0.9% respectively. Median hospital stay was 7 [2-10] days, 4.5 [1-9] in case of no complications. Stent dysfunction occurred in 17.1% after a median of 103.5 [42.5-168.0] days, resulting in a 72% probability of 6-months dysfunction-free survival. Comparing the 3 techniques, benign diseases were more prevalent among RVs (p=0.0004), while hilar/anastomotic strictures were mainly managed through HGs (p<0.0001). Technical failures were higher among RVs (p=0.036). No difference in clinical success or severe adverse events was identified. A lesser extent of bilirubin decrease was noticed among HGs (≥50% decrease in 53.3% vs. 66.7% and 96% of RVs and ASs; p=0.007), which may be attributed to a significantly higher rate of disconnected ducts (53.5% vs. 6.2 and 2.2%, p<0.0001). A trend towards reduced stent dysfunction was noted when HGs were created with half-covered purpose-specific stents (N=17 [38%]) vs. older stents (6.7% vs. 31.6%, p=0.0789). The intrahepatic route for EUS-guided biliary drainage in failed ERCPs or surgically altered anatomy has a good clinical efficacy, a relatively low dysfunction rate and an acceptable safety profile. These results seem especially valuable for indications in which the only alternative would be percutaneous drainage. Increased technical expertise, specifically designed tools and high-quality comparisons are compelling for a standardized inclusion of this technique in the endoscopic armamentarium of tertiary referral centres.

EUS-guided biliary drainage in patients with distal malignant biliary obstruction requires fewer interventions and has a lower cost compared to ERCP biliary drainage.

Endoscopic retrograde cholangiopancreatography (ERCP) biliary drainage is considered the reference standard in patients with biliary obstruction, but it is not free of complications. EUS-guided biliary drainage (EUS-BD) is considered an alternative in patients with failed ERCP; however, data are scarce as to whether EUS-BD could be considered a first option. The aim of our study was to compare the need for reintervention and cost between ERCP biliary drainage vs. EUS-BD. We conducted a retrospective and comparative study of patients with distal malignant biliary obstruction with biliary drainage with ERCP + plastic stent (ERCP-PS) vs. ERCP + metal stent (ERCP-MS) vs. EUS-BD. 124 patients were included, divided into three groups: ERCP-PS, 60 (48.3%) patients; ERCP-MS, 40 (32.2%) patients; and EUS-BD, 24 (19.3%) patients. The need for reinterventions (67 vs. 37 vs. 4%, respectively), the number of procedures [3 (1-10) vs. 2 (1-7) vs. 1 (1-2)], and the costs (4550 ± 3130 vs. 5555 ± 3210 vs. 2375 ± 1020 USD) were lower in the EUS-BD group. No differences in terms of complications were detected. EUS-BD requires fewer reinterventions and has a lower cost compared to drainage by ERCP with metal or plastic stents.

EUS-Guided Versus ERCP-Guided Biliary Drainage for Primary Treatment of Distal Malignant Biliary Obstruction

EUS-Guided Versus ERCP-Guided Biliary Drainage for Primary Treatment of Distal Malignant Biliary Obstruction

Antiplatelet and/or anticoagulant treatment does not increase hemorrhagic adverse events during EUS-guided biliary drainage

No data appear to have been reported regarding bleeding risk among patients receiving antiplatelet and/or anticoagulant treatment (AP/AC) during EUS-guided biliary drainage (BD) procedures. The aim of this study was to assess whether hemorrhagic adverse events associated with EUS-BD are increased in patients on AP/AC. Patients receiving AP/AC who underwent EUS-BD were retrospectively enrolled between May 2015 and August 2019. Patients who did not receive AP/AC and underwent EUS-BD in the same period were also enrolled as a control group. One hundred ninety-five patients who underwent EUS-BD were enrolled in this study. Among these, 154 patients were allocated to the control group and 41 patients to the AP/AC group. Overall frequency of adverse events did not differ significantly between the control group (16.2%, 25/154) and AC/AP group (17.1%, 6/41; P= .80). The overall bleeding event rate was 3.6% (7/195), with no significant difference between the 2 groups. No thromboembolic events were observed with or without interruption of AP/AC. According to logistic regression analysis, the use of AP/AC was not a risk factor significantly associated with bleeding events (odds ratio, 2.96; 95% confidence interval, .56-14.0; P= .18). On the other hand, a long procedure time (>20 minutes) was an independent risk factor associated with bleeding events. Bleeding events appear to be infrequent among patients who undergo EUS-BD while continuing AP/AC.

Comparison of Biliary Drainage Techniques for Malignant Biliary Obstruction: A Systematic Review and Network Meta-Analysis

Background: The various techniques for relief of malignant biliary obstruction include endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic biliary drainage (PTBD), and endoscopic ultrasound guided biliary drainage (EUS-BD). We conducted a systematic review and network meta-analysis (NMA) comparing all three modalities with respect to efficacy, adverse events, and re-intervention rate. Methods: We searched multiple databases from inception to October 2019 to identify comparative studies of malignant biliary obstruction patients treated with EUS-BD, ERCP or PTBD. Outcomes of interest were technical success, clinical success, adverse events and need for re-intervention. Pooled odds ratios (OR) were calculated and analyzed using the random effects model. To incorporate indirect comparisons, we conducted NMA using a multivariate, consistency model with random-effects meta-regression. We followed the GRADE approach to rate the certainty of evidence. Findings: We included 17 studies; of which 8 were randomized (3 EUS vs ERCP; 1 EUS vs PTBD; 13 ERCP vs PTBD) with 1566 patients (220: EUS vs ERCP; 33: EUS vs PTBD; 1313: ERCP vs PTBD). NMA did not show statistically significant differences to favor one intervention with certainty over the other across multiple outcomes. The analysis suggested that PTBD may have a higher clinical and technical success rate than ERCP and that EUS may have a lower re-intervention rate than ERCP. Interpretation: The available evidence cannot favor one of the 3 interventions with certainty across multiple outcomes. Shared-decision making is recommended to choose the approach most consistent with patient’s values, goals of treatment and comorbidities and consider the availability of procedural expertise. Funding: None. Conflict of Interest: None.

Double Stenting for Malignant Biliary and Duodenal Obstruction: A Systematic Review and Meta-Analysis

INTRODUCTION:Data about the efficacy of palliative double stenting for malignant duodenal and biliary obstruction are limited.METHODS:A systematic literature search was performed to assess the feasibility and optimal method of double stenting for malignant duodenobiliary obstruction compared with surgical double bypass in terms of technical and clinical success, adverse events, reinterventions, and survival. Event rates with 95% confidence intervals were calculated.RESULTS:Seventy-two retrospective and 8 prospective studies published until July 2018 were included. Technical and clinical success rates of double stenting were 97% (95%–99%) and 92% (89%–95%), respectively. Clinical success of endoscopic biliary stenting was higher than that of surgery (97% [94%–99%] vs 86% [78%–92%]). Double stenting was associated with less adverse events (13% [8%–19%] vs 28% [19%–38%]) but more frequent need for reintervention (21% [16%–27%] vs 10% [4%–19%]) than double bypass. No significant difference was found between technical and clinical success and reintervention rate of endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic drainage, and endoscopic ultrasound-guided biliary drainage. ERCP was associated with the least adverse events (3% [1%–6%]), followed by percutaneous transhepatic drainage (10% [0%–37%]) and endoscopic ultrasound-guided biliary drainage (23% [15%–33%]).DISCUSSION:Substantially high technical and clinical success can be achieved with double stenting. Based on the adverse event profile, ERCP can be recommended as the first choice for biliary stenting as part of double stenting, if feasible. Prospective comparative studies with well-defined outcomes and cohorts are needed.

Endoscopic Retrograde Cholangiopancreatography in Patients With Surgically Altered Anatomy

This review describes the recent advances and evolving techniques in endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy (SAA) and highlights the novel alternative approaches for pancreato-biliary interventions in this group of patients. The limitations of ERCP in patients with SAA have led to the development of improved endoscopic devices and accessories, and alternative approaches for pancreato-biliary interventions. Dedicated short-type single and double balloon enteroscopes (BE) have been developed with increased maneuverability and larger accessory channels that enhance scope insertion and allow the use of various ERCP devices, respectively. In failed BE-ERCP cases, endoscopic ultrasound-guided biliary drainage (EUS-BD) has been used to gain access to the pancreato-biliary system, with high reported procedural success. More recently, lumen-apposing metal stent (LAMS) has been used to create a temporary bridge to the excluded stomach in Roux-en-Y gastric bypass (RYGB), and the small bowel loop in other altered GI anatomy, through which conventional ERCP can be performed, with excellent preliminary results. Several novel approaches and techniques are developed and being evaluated for pancreato-biliary intervention in patients with SAA. The optimal approach should be considered based on patient history, institutional factors, and multidisciplinary collaboration.

Clinical utility of treatment method conversion during single-session endoscopic ultrasound-guided biliary drainage.

BACKGROUNDAlthough several techniques for endoscopic ultrasound-guided biliary drainage (EUS-BD) are available at present, an optimal treatment algorithm of EUS-BD has not yet been established.AIMTo evaluate the clinical utility of treatment method conversion during single endoscopic sessions for difficult cases in initially planned EUS-BD.METHODSThis was a single-center retrospective analysis using a prospectively accumulated database. Patients with biliary obstruction undergoing EUS-BD between May 2008 and April 2016 were included. The primary outcome was to evaluate the improvement in EUS-BD success rates by converting the treatment methods during a single endoscopic session. Secondary outcomes were clarification of the factors leading to the conversion from the initial EUS-BD and the assessment of efficacy and safety of the conversion as judged by technical success, clinical success, and adverse events (AEs).RESULTSA total of 208 patients underwent EUS-BD during the study period. For 18.8% (39/208) of the patients, the treatment methods were converted to another EUS-BD technique from the initial plan. Biliary obstruction was caused by pancreatobiliary malignancies, other malignant lesions, biliary stones, and other benign lesions in 22, 11, 4, and 2 patients, respectively. The reasons for the difficulty with the initial EUS-BD were classified into the following 3 procedures: Target puncture (n = 13), guidewire manipulation (n = 18), and puncture tract dilation (n = 8). Technical success was achieved in 97.4% (38/39) of the cases and clinical success was achieved in 89.5% of patients (34/38). AEs occurred in 10.3% of patients, including bile leakage (n = 2), bleeding (n = 1), and cholecystitis (n = 1). The puncture target and drainage technique were altered in subsequent EUS-BD procedures in 25 and 14 patients, respectively. The final technical success rate with 95%CI for all 208 cases was 97.1% (95%CI: 93.8%-98.9%), while that of the initially planned EUS-BD was 78.8% (95%CI: 72.6%-84.2%).CONCLUSIONAmong multi-step procedures in EUS-BD, guidewire manipulation appeared to be the most technically challenging. When initially planned EUS-BD is technically difficult, treatment method conversion in a single endoscopic session may result in successful EUS-BD without leading to severe AEs.

EUS-guided choledochoduodenostomy by use of electrocautery-enhanced lumen-apposing metal stents: a French multicenter study after implementation of the technique (with video)

EUS-guided biliary drainage is indicated in cases of impossibility or failure of classic biliary drainage by ERCP. Recently we reported good efficiency of EUS-guided choledochoduodenostomy (EUS-CDS) using the electrocautery-enhanced lumen-apposing metal stent (ECE-LAMS) in a retrospective multicenter study. Use of the recommended technique (direct puncture with the ECE-LAMS with use of a pure cut current and a 6-mm stent) was the only predictive factor of clinical success. We re-evaluated this procedure after 1 year in the same centers. This was a French retrospective multicenter study of a prospective database including all cases of EUS-guided CDS with ECE-LAMS in the 7 centers that participated in the first study. Seventy consecutive patients were included in this study between September 1, 2017, and September 22, 2018. Failure of primary ERCP was due to duodenal stenosis in 44% of cases and to tumoral infiltration of the papilla in 22% of cases. The mean duration of the procedure was 5 ± 3 minutes. The recommended technique was used in 98.5% of cases. The technical and clinical success rates were both 97.1% (69/70). Short-term adverse events (periprocedural and intrahospital) occurred in 1.6%. EUS-CDS with the ECE-LAMS is efficacious and safe in distal malignant obstruction of the common bile duct in cases of ERCP failure with impressive results once expertise is acquired and the recommended technique (direct fistulotomy, pure cut current, and 6-mm stent) is followed.

Novel transluminal treatment protocol for hepaticojejunostomy stricture using covered self-expandable metal stent.

Hepaticojejunostomy anastomotic stricture (HJS) is a rare complication after pancreatoduodenostomy. However, the rate of HJS may be increased with the expansion of operative indications, such as intraductal papillary mucinous neoplasm. Recently, the indications for EUS-guided biliary drainage to treat benign biliary disease have expanded. Recently, novel transluminal treatment protocol has been established in our hospital. The aim of this study was thus to evaluate the technical feasibility and safety of our treatment protocol. Consecutive patients with complications of HJS between January and December 2018 were enrolled in this study. EUS-guided hepaticogastrostomy (HGS) is firstly performed. After 7days to create the fistula, HGS stent is removed. HJS is transluminally evaluated by a cholangioscope, and antegrade balloon dilation is attempted. After 3months, if HJS is still presence, antegrade stent deployment is performed using a covered metal stent. Also, after 1month, antegrade stent removal is transluminally performed. Among total 29 patients, 14 patients were underwent antegrade metal stent deployment. The technical success rate of antegrade stent deployment was 92.9%. Median period of stent placement was 30.5days (range 28-38days), and transluminal stent removal was successfully performed in all patients. During follow-up (median 278days; range 171-505days), recurrence of HJS was seen in 2 patients. Severe adverse events were not seen in any patients during follow-up period. Transluminal stent deployment for HJS under EUS-guidance appears feasible and safe, although further study with a larger sample size and longer follow-up is warranted.

Endoscopic ultrasound-guided biliary drainage for malignant biliary obstruction with surgically altered anatomy: a multicenter prospective registration study.

Background:Endoscopic treatment for malignant biliary obstruction (MBO) in patients bearing surgically altered anatomy (SAA) is not well-established. Although endoscopic ultrasound-guided biliary drainage (EUS-BD) has emerged as a new treatment option for MBO, limited data are available regarding the efficacy and safety of EUS-BD in patients with SAA. We conducted a multicenter prospective registration study to evaluate the efficacy and safety of EUS-BD in this population.Methods:This study involved 10 referral centers in Japan. Patients with SAA who were scheduled to receive EUS-BD for unresectable MBO between May 2016 and September 2018 were prospectively registered. The primary endpoint was technical success and the secondary outcomes were clinical success, procedure time, procedure-related adverse events (AEs), stent patency, and overall survival.Results:In total, 40 patients were prospectively enrolled. The surgical reconstruction methods were gastrectomy with Roux-en-Y reconstruction (47.5%), gastrectomy with Billroth-II reconstruction (15%), pancreaticoduodenectomy (27.5%), and hepaticojejunostomy with Roux-en-Y reconstruction (10%). EUS-BD was performed for primary biliary drainage in 31 patients and for rescue biliary drainage in nine patients. Transmural stenting alone (60%), antegrade stenting alone (5%), and a combination of the two techniques (35%) were selected for patients treated with EUS-BD. Technical and clinical success rates were 100% (95% confidence interval, 91.2–100.0%) and 95% (95% confidence interval, 83.1–99.4%), respectively. Mean procedure time was 36.5 min. Early AEs were noted in six patients (15%): three self-limited bile leak, one bile peritonitis, and two pneumoperitonea. Late AEs occurred in six patients (15%): one jejunal ulcer and five stent occlusions. Stent patency rate after 3 months of survival was 95.7% (22/23). Median overall survival was 96 days.Conclusion:EUS-BD for MBO in patients with SAA appears to be effective and safe not only as a rescue drainage technique after failed endoscopic retrograde cholangiography but also as a primary drainage technique.Clinical Trial Registration:UMIN000022101

Novel swine biliary dilatation model with temperature-controlled endobiliary radiofrequency ablation: An effective tool for training in EUS-guided biliary drainage.

Background and Objectives:EUS-guided biliary drainage (EUS-BD) is used as a rescue method after failed endoscopic retrograde cholangiography. However, it is considered a technically challenging procedure. Phantoms and ex vivo biliary dilatation models have been used to enhance the learning of EUS-BD, but they provide a limited level of realism. The aim of this study was to develop a swine biliary dilatation model that uses temperature-controlled endobiliary radiofrequency ablation (EB-RFA) for training in EUS-BD.Materials and Methods:Target temperature-controlled (80°C at 7 or 10 W for 60–120 s) EB-RFA was performed on seven pigs. Two weeks after the EB-RFA, EUS examination was performed to confirm biliary dilatation, and EUS-BD was then attempted by performing a hepaticogastrostomy (HGS) or cholecystogastrostomy (CGS).Results:Twelve sessions of EB-RFA (11 at the distal common bile duct [CBD] and one at the proximal CBD) were successfully performed on the seven pigs. There were no immediate postprocedural adverse events. Two weeks after the procedures, clinical signs of jaundice were observed in all the pigs. EUS examination revealed massive intrahepatic and extrahepatic biliary dilatations in all the pigs, and EUS-BD was attempted in the same session. HGS was performed on six pigs. Technical success was achieved in five of the six pigs (83.3%). Technical failure in HGS occurred during the stent deployment, and CGS was successfully performed on one pig.Conclusions:Our study shows that EB-RFA is an effective minimally invasive method for creating biliary dilatation models. It may be considered suitable for training in EUS-BD.

Primary EUS-guided biliary drainage versus ERCP drainage for the management of malignant biliary obstruction: A systematic review and meta-analysis

EUS-guided biliary drainage (EUS-BD) has been used as a salvage modality for relief of malignant biliary obstruction (MBO) after a failed ERCP. Multiple recent randomized controlled trials (RCTs) and observational studies have been published to assess the suitability of EUS-BD as a first-line modality for achieving palliative BD. We aimed to perform a systematic review and meta-analysis comparing primary EUS-BD versus ERCP for MBO. We searched PubMed, Medline, and Embase up to January 1, 2019, to identify RCTs and observational studies evaluating the efficacy and safety of primary EUS-BD (without a prior attempted ERCP) versus ERCP. Quality of RCTs and observational studies was assessed using Jadad and Newcastle–Ottawa scores, respectively. The outcomes of interest were technical success, clinical success, odds of requiring a repeat intervention, and procedure-related adverse events. Odds ratios (ORs) and standard mean difference were calculated for categorical and continuous variables, respectively. Meta-analysis was performed using the random effects model in RevMan 5.3 (the Cochrane Collaboration, the Nordic Cochrane Centre, Copenhagen, Denmark). Five studies (three RCTs and two observational studies) with 361 patients were included. Both procedures achieved comparable technical success (OR: 1.20 [0.44–3.24], I2 = 0%) and clinical success (OR: 1.44, confidence interval [CI]: 0.63–3.29, I2 = 0%). The overall adverse outcomes (OR: 1.59 [0.89–2.84]) did not differ between the two groups. In the ERCP group, 9.5% of patients developed procedure-related pancreatitis versus zero in the EUS group (risk difference = 0.08%, P = 0.02). There was no statistically significant difference in nonpancreatitis-related adverse events. The odds of requiring reintervention for BD (1.68 [0.76–3.73], I2 = 42%) did not differ significantly. The ERCP group had significantly higher odds of requiring reintervention due to tumor overgrowth (5.35 [1.64–17.50], I2 = 0%). EUS-BD has comparable technical and clinical success to ERCP and can potentially be used as a first-line palliative modality for MBO where expertise is available. ERCP-related pancreatitis which can cause significant morbidity can be completely avoided with EUS.