Prospective international multicenter study on endoscopic ultrasound-guided biliary drainage for patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography.
OBJECTIVE
Endoscopic ultrasound-guided biliary drainage (EUS-BD) has emerged as an alternative to traditional radiologic and surgical drainage procedures after failed endoscopic retrograde cholangiopancreatography (ERCP). However, prospective multicenter data are lacking. The aims of this study were to prospectively assess the short- and long-term efficacy and safety of EUS-BD in patients with malignant distal biliary obstruction.


METHODS
Consecutive patients at 12 tertiary centers (5 US, 5 European, 1 Asian, 1 South American) with malignant distal biliary obstruction and failed ERCP underwent EUS-BD. Technical success was defined as successful stent placement in the desired position. Clinical success was defined as a reduction in bilirubin by 50 % at 2 weeks or to below 3 mg/dL at 4 weeks. Adverse events were prospectively tracked and graded according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon's severity grading system. Overall survival and duration of stent patency were calculated using Kaplan-Meier analysis.


RESULTS
A total of 96 patients (mean age 66 years, female 45 %, pancreatic cancer 55 %) underwent EUS-BD. Stent placement (technical success) was achieved in 92 (95.8 %) patients (metallic stent 84, plastic stent 8). Mean procedure time was 40 minutes. Clinical success was achieved in 86 (89.5 %) patients. A total of 10 (10.5 %) adverse events occurred: pneumoperitoneum (n = 2), sheared wire (n = 1), bleeding (n = 1), bile leak (n = 3), cholangitis (n = 2), and unintentional perforation (n = 1); 4 graded as mild, 4 moderate, 1 severe, and 1 fatal (due to perforation). A total of 38 (44 %) patients died of disease progression during the study period. The median patient survival was 167 days (95 %CI 112 - 221) days. The 6-month stent patency rate was 95 % (95 %CI 94.94 - 95.06 %) and the 1-year stent patency was 86 % (95 %CI 85.74 - 86.26 %).


CONCLUSIONS
This study on EUS-BD demonstrates excellent efficacy and safety of EUS-BD when performed by experts.


BACKGROUND
NCT01889953.
Johns Hopkins Medical Institute, Baltimore, MD, USA.
Mouen A
MA
Khashab
Department of Hepatology, Division of Liver, and Pancreatico-Biliary Disorders, University Hospital Gastuisberg, University of Leuven, Leuven Belgium.
Schalk
S
Van der Merwe
Aarhus University Hospital, Aarhus, Denmark.
Rastislav
R
Kunda
Johns Hopkins Medical Institute, Baltimore, MD, USA.
Mohamad H
MH
El Zein
Department of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong SAR, China.
Anthony Y
AY
Teoh
Department of Surgery, University of Sao Paulo, Sao Paulo, Brazil.
Fernando P
FP
Marson
Unit of Gastroenterology and Digestive Endoscopy, AUSL Bologna Bellaria-Maggiore Hospital, Bologna, Italy.
Carlo
C
Fabbri
Endoscopy Service, Department of Diagnostic and Therapeutic Services, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), Palermo, Italy.
Ilaria
I
Tarantino
Center for Interventional Endoscopy, Florida Hospital, Orlando, FL, USA.
Shyam
S
Varadarajulu
Winthrop University Hospital, Mineola, NY, USA.
Rani J
RJ
Modayil
Winthrop University Hospital, Mineola, NY, USA.
Stavros N
SN
Stavropoulos
Hospital Universitario Rio Hortega, Valladolid, Spain.
Irene
I
Peñas
Johns Hopkins Medical Institute, Baltimore, MD, USA.
Saowanee
S
Ngamruengphong
Johns Hopkins Medical Institute, Baltimore, MD, USA.
Vivek
V
Kumbhari
Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, SC, USA.
Joseph
J
Romagnuolo
Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Raj
R
Shah
Johns Hopkins Medical Institute, Baltimore, MD, USA.
Anthony N
AN
Kalloo
Hospital Universitario Rio Hortega, Valladolid, Spain.
Manuel
M
Perez-Miranda
Department of Surgery, University of Sao Paulo, Sao Paulo, Brazil.
Everson L
EL
Artifon