EUS-guided biliary drainage with one-step placement of a fully covered metal stent for malignant biliary obstruction: a prospective feasibility study.

OBJECTIVES: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.