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

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

Endoscopic ultrasound-guided drainage of the biliary tree in malignant obstruction

“…Second, it allows creation of an anastomosis at a distance from the tumor, thus avoiding the risk of ingrowth or overgrowth with consequent stent dysfunction. Furthermore, EUS-BD can target different sites of the biliary tree, thus allowing drainage also in unfavorable situations both for ERCP, such as gastric outlet obstruction or post-surgical anatomy, and for PTBD such as ascites or liver lesions [18] . In comparison with PTBD, EUS-BD appears to be faster and more costsaving, since the procedure can be performed immediately after ERCP, thus avoiding repeated procedures and prolonged hospital stays [19][20][21] .…”

State-Of-The-Art Endoscopic Procedures for Pancreatic Cancer

“…A large multicenter study on EUS-guided biliary drainage after failed ERCP was recently published, it included 12 tertiary care centers in different continents and enrolled 96 patients where 55% of patients had pancreatic cancer. This procedure showed to be highly efficacious with over a 95% technical success rate, a mean procedure time of 40 min and relatively safe with a low number of adverse events [57].…”

Compliance with evidence‐based multidisciplinary guidelines on perihilar cholangiocarcinoma

“…Technical success was defined as successful bile duct cannulation with stent/catheter placement providing internal biliary drainage. 3 Therapeutic success of the initial procedure was defined as a more than 50% decrease in total bilirubin level within two weeks 18,19 or, when laboratory values were missing, as a decrease in jaundice and cholestasis. A decrease in cholestasis was defined by diminished bile duct dilatation in the drained liver segments on subsequent imaging.…”

“…Patients had a median age of 66 years, included 104 males (65.8%) and presented with jaundice in the majority of cases (75.9%). Median time interval between first suspicion of PHC at the regional center and referral to our MDT was 11 days (IQR: [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20]. In 39 of 158 cases (24.7%), the time to referral was 21 days or more.…”