“Endoscopic ultrasound-guided choledochoduodenostomy versus endoscopic retrograde cholangiopancreatography for primary biliary decompression in distal malignant biliary obstruction: a randomized comparative study”

Abstract

Few studies have compared endoscopic ultrasound-guided biliary drainage (EUS-BD) with endoscopic retrograde cholangiopancreatography (ERCP-BD) as a primary procedure for distal malignant biliary decompression with variable results and small sample size. We conducted this this with the aim of comparing EUS-BD versus ERCP-BD for primary biliary decompression. We designed a randomized controlled study and conducted it in our center on 100 patients with diagnosis of unresectable distal malignant biliary obstruction, randomization to EUS-BD group or ERCP-BD group was done. Technical and clinical successes, procedure time, adverse events and stent dysfunctions were compared in both groups. The demographic data showed that there were 60 male patients and 40 female patients, and their mean age was 64.8 years. Regarding the study endpoints, we succeeded to achieve technical success in all patients (100%) in the two groups/arms. Also, we reported Clinical success rates of 90.9% (40 / 44 patients) in EUS-BD arm and 95.6% (44 / 46 patients) in ERCP-BD arm (P-value = 0.429). The median procedure time was 13.29 min in EUS-BD arm and 15 min in ERCP-BD arm (P-value = 0.893). No difference of statistical significance regarding the rate of overall adverse events between both arms (P-value = 0.862). For stent dysfunction, stent patency was similar in both arms. Two patients in the EUS-BD arm reported stent migration without need for reintervention. EUS-BD showed similar results regarding technical and clinical success, procedure time, overall adverse events, and reinterventions rates as a method of primary biliary decompression in cases of unresectable distal malignant biliary obstruction compared to ERCP-BD.