Endoscopic ultrasound (EUS)-guided biliary drainage (EUSBD) with plastic stents has been introduced as an alternative to percutaneous transhepatic biliary drainage (PTBD) in cases of biliary obstruction when endoscopic retrograde cholangiopancreatography (ERCP) is unsuccessful. Although self-expandable metallic stents with a larger diameter might offer long-lasting patency compared with plastic stents, to date, EUSBD with one-step placement of a fully covered self-expandable metal stent (FCSEMS) has not been evaluated. We conducted this study to determine the feasibility and usefulness of EUSBD with one-step placement of FCSEMS. A prospective feasibility study on EUSBD with one-step placement of FCSEMS was carried out in 14 patients with malignant biliary obstruction who were candidates for alternative techniques for biliary decompression because of unsuccessful ERCP. The technical and functional success rate was 100% (14/14). Nine patients were treated using the intrahepatic approach. The remaining five patients were treated using the extrahepatic approach. With the intrahepatic approach, two patients showed self-limited pneumoperitoneum. With the extrahepatic approach, no patients had pneumoperitoneum. No bile peritonitis or cholangitis was observed after the procedure in any of the patients treated using the intra- or extrahepatic approach. During follow-up periods (median 6 months), one case of re-intervention (7%, 1/14) necessitated by distal stent migration was observed. EUSBD with one-step placement of an FCSEMS may be feasible, safe, and effective as an alternative to PTBD in cases of malignant biliary obstruction when ERCP is unsuccessful. Prospective randomized trials of EUSBD with plastic stent vs. EUSBD with FCSEMS may be needed.

Although endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) with transmural stenting has increased for biliary decompression in patients with an inaccessible papilla, the optimal biliary access point and the learning curve of EUS-HGS have not been studied. We evaluated the optimal biliary access point and learning curve for technically successful EUS-HGS. 129 consecutive patients (male n = 81, 62.3%; malignant n = 113, 87.6%) who underwent EUS-HGS due to an inaccessible papilla were enrolled. EUS finding and procedure times according to each needle puncture attempt in EUS-HGS were prospectively measured. Learning curves of EUS-HGS were calculated for two main outcome measurements (procedure time and adverse events) by using the moving average method and cumulative sum (CUSUM) analysis, respectively. A total of 174 EUS-HGS attempts were performed in 129 patients. The mean number of needle punctures was 1.35 ± 0.57. Using the logistic regression model, bile duct diameter of the puncture site ⩽ 5 mm [odds ratio (OR) 3.7, 95% confidence interval (CI): 1.71–8.1, p < 0.01] and hepatic portion length [linear distance from the mural wall to the punctured bile duct wall on EUS; mean hepatic portion length was 27 mm (range 10–47 mm)] > 3 cm (OR 5.7, 95% CI: 2.7–12, p < 0.01) were associated with low technical success. Procedure time and adverse events were shorter after 24 cases, and stabilized at 33 cases of EUS-HGS, respectively. Our data suggest that a bile duct diameter > 5 mm and hepatic portion length 1 cm to ⩽ 3 cm on EUS may be suitable for successful EUS-HGS. In our learning curve analysis, over 33 cases might be required to achieve the plateau phase for successful EUS-HGS.