Prospective international multicenter study on endoscopic ultrasound-guided biliary drainage for patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography

Mouen A Khashab, Schalk Van der Merwe, Rastislav Kunda, Mohamad H El Zein, Anthony Y Teoh, Fernando P Marson, Carlo Fabbri, Ilaria Tarantino, Shyam Varadarajulu, Rani J Modayil, Stavros N Stavropoulos, Irene Peñas, Saowanee Ngamruengphong, Vivek Kumbhari, Joseph Romagnuolo, Raj Shah, Anthony N Kalloo, Manuel Perez-Miranda, Everson L Artifon, Mouen A Khashab, Schalk Van der Merwe, Rastislav Kunda, Mohamad H El Zein, Anthony Y Teoh, Fernando P Marson, Carlo Fabbri, Ilaria Tarantino, Shyam Varadarajulu, Rani J Modayil, Stavros N Stavropoulos, Irene Peñas, Saowanee Ngamruengphong, Vivek Kumbhari, Joseph Romagnuolo, Raj Shah, Anthony N Kalloo, Manuel Perez-Miranda, Everson L Artifon

Abstract

Background and aims: 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.

Patients and 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 %).

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

Study registration: NCT01889953.

Conflict of interest statement

Competing interests: Mouen Khashab is a consultant for Boston Scientific, Olympus America, and Xlumena. Schalk van der Merwe is a consultant for Boston Scientific and Cook Endoscopy. Manuel Perez-Miranda is a consultant for Boston Scientific and Xlumena.

Figures

Fig. 1
Fig. 1
Endoscopic ultrasound-guided biliary drainage (EUS-BD) using the rendezvous technique in a patient with ampullary carcinoma and two prior failed endoscopic retrograde cholangiopancreatography (ERCP) procedures. a Fluoroscopic image demonstrating a cholangiogram after puncture of the left main hepatic duct. b Successful passage of guidewire through the papilla into the duodenum. c Endoscopic image after the wire has been collected from the duodenum. d Retrograde cannulation of the common bile duct (CBD). e Fluoroscopic image during self-expandable metallic stent (SEMS) deployment. f Fluoroscopic image demonstrating transpapillary SEMS deployment.
Fig. 2
Fig. 2
Endoscopic ultrasound-guided biliary drainage (EUS-BD) with choledochoduodenostomy (CDS) in a patient with distal common bile duct (CBD) obstruction due to a cancer in the head of the pancreas. a Sonographic image demonstrating a dilated CBD about to be punctured. b Fluoroscopic image demonstrating cholangiogram and guidewire in the right hepatic duct. c Fluoroscopic image during self-expandable metallic stent (SEMS) deployment. d Endoscopic image of SEMS in the duodenal bulb.
Fig. 3
Fig. 3
Endoscopic ultrasound-guided biliary drainage (EUS-BD) with hepatogastrostomy (HGS) in a patient with Bismuth II cholangiocarcinoma. a Sonographic image of puncture of the left main hepatic duct. b Fluoroscopic image of cholangiogram and guidewire insertion. c Fluoroscopic image of self-expandable metallic stent (SEMS) deployment. d Endoscopic image of SEMS deployment. Note the proximity to the gastroesophageal junction.
Fig. 4
Fig. 4
Endoscopic ultrasound-guided biliary drainage (EUS-BD) using the AGS approach in a patient with a large mass in the head of the pancreas causing biliary obstruction. a Fluoroscopic image of puncture of the left main hepatic duct and cholangiogram demonstrating an absence of filling in the extrahepatic bile duct. b Guidewire passed through the stricture into the duodenum (confirmed by enterogram). c Dilation of biliary stricture to facilitate self-expandable metallic stent (SEMS) placement. d Fluoroscopic image of SEMS deployed across the stricture.
Fig. 5
Fig. 5
Trend of decreasing bilirubin at 2 weeks and 4 weeks (2 weeks: 14 ± 8.8 vs. 5.8 ± 9.7 mg/dL, P < 0.0001; 4 weeks: 14 ± 8.8 vs. 1.86 ± 1.4 mg/dL, P < 0.0001).
Fig. 6
Fig. 6
Kaplan–Meier curve showing cumulative stent patency. There was no statistically significant difference in stent patency between the transluminal vs rendezvous/AGS groups (P = 0.73, log-rank test).
Fig. 7
Fig. 7
Kaplan–Meier curve showing cumulative stent patency. One-year stent patency was 86 % (95 %CI 85.74 – 86.26 %).
Fig. 8
Fig. 8
Kaplan–Meier curve showing cumulative patient survival. Median overall survival was 167 days (± 27 days).

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