Real-world Evaluation of Different Endoscopic Biliary Drainage Techniques in Patients With Jaundice of Biliopancreatic Malignant Origin

Condition(s) studied

Investigational drug(s) / intervention(s)

Endoscopic drainage: Choice of modalities: ERCP, EUS-guided gallbladder drainage (EUS-GBD), EUS-guided choledochoduodenostomy (EUS-CDS), and EUS-guided hepaticogastrostomy (EUS-HGS)

Study summary

The incidence of pancreatic cancer is rising. Tumor-induced obstruction of the distal bile duct is a common complication, occurring during the course of nearly 80% of pancreatic tumors. Approximately 10% of these obstructions are complicated by cholangitis, and jaundice is associated with tumor progression due to the resulting impairment of cellular immunity. The standard treatment for distal bile duct obstruction is transpapillary drainage via endoscopic retrograde cholangiopancreatography (ERCP). This procedure is performed under general anesthesia and carries a failure rate of 15% and a complication rate of up to 9%. In recent years, alternative techniques for endoscopic ultrasound (EUS)-guided biliary drainage have been developed, such as hepaticogastrostomy, choledochoduodenostomy, and cholecystogastrostomy. These EUS-guided biliary drainage techniques overcome failures caused by malignant duodenal stenosis (present in up to 25% of such cases), with lower morbidity and greater clinical efficacy compared to percutaneous radiological drainage. EUS-guided biliary drainage techniques have been simplified by the advent of lumen-apposing metal stents (LAMS), which have enabled technical success rates of nearly 90%. The two techniques most frequently described in the literature are choledochoduodenostomy (CDS)-connecting the common bile duct to the duodenal bulb-and hepaticogastrostomy (HGS)-connecting the left intrahepatic bile ducts to the stomach. CDS is less morbid and technically easier to perform but has limitations in cases of duodenal stenosis, an insufficiently dilated common bile duct, or an unfavorable puncture window. For a long time, endoscopic gallbladder drainage via cholecystogastrostomy (CGS) was restricted to treating acute cholecystitis in patients ineligible for surgery; its use for biliary drainage in cases of malignant jaundice remained anecdotal, for reasons that were not clearly identified. The investigators were the first to publish a multicenter comparative study contrasting CGS with CDS following failed ERCP for distal malignant biliary obstruction. This study demonstrated comparable technical and clinical success rates for both techniques, with a better long-term morbidity profile favoring CGS. More recently, a large-scale international multicenter study validated the efficacy of gallbladder drainage compared to common bile duct drainage as a first-line approach. The study team previously launched the COPPINE cohort (Prospective Cohort of Innovative Endoscopic Procedures) in 2024, aiming to continuously enroll all patients undergoing innovative endoscopic procedures, including endoscopic ultrasound-guided biliary drainage. This study aims to prospectively compare the clinical outcomes of patients with malignant distal biliary obstruction based on the biliary drainage technique they received.

Eligibility

Primary outcome measure(s)

• Biliary stent dysfunction between different endoscopic drainage modalities — Month 12
  Yes/no, according to Guidelines on Reporting Outcomes in Biliary Drainage Trials

Trial sites (6)

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