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

NCT07817602 | Not Yet Recruiting

• 1 other identifier: NIMAO/2025-2/LC01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Biliary Drainage; Pancreatic Cancer; Endoscopic Ultrasound-Guided Drainage

Keywords

Gallbladder drainage; Choledochoduodenostomy

Outcome Measures

Primary Outcomes (1)

• Biliary stent dysfunction between different endoscopic drainage modalities

  Yes/no, according to Guidelines on Reporting Outcomes in Biliary Drainage Trials

  Month 12

Secondary Outcomes (46)

• Technical success rate of biliary stent placement with immediate visualization of biliary flow during the procedure between different endoscopic drainage modalities

  Month 12

• Clinical success

  Month 12

• Use of advanced cannulation techniques versus endoscopic ultrasound (EUS)-guided techniques in cases of difficult ERCP

  Month 12

• Segment showing highest drainage efficacy

  Month 12

• Tumor stage

  Month 12

Study Arms (1)

Patients undergoing endoscopic drainage

Procedure: Endoscopic drainage

Interventions

Endoscopic drainage PROCEDURE

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

Patients undergoing endoscopic drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with distal biliary obstruction of malignant etiology (pancreas, ampulloma, compressive metastatic lymphadenopathy, other distal tumors, with planned biliary drainage.

You may qualify if:

• Distal biliary obstruction of malignant etiology (pancreas, ampulloma, compressive metastatic lymphadenopathy, other distal tumors).
• Decision made to proceed with biliary drainage.
• Patient informed and no objection raised, in accordance with the MR-004 framework and COPPINE procedure

You may not qualify if:

• The subject is participating in another study
• The subject unable to expression on-objection
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• Proximal/hilar or benign obstruction (non-tumoral lesions).
• Contraindication to endoscopy/anesthesia (uncorrectable hemodynamic instability, uncontrolled coagulation disorders, etc.).
• History of prior biliary drainage.
• Pregnant or breastfeeding patient.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (6)

CHU Dupuytren

Limoges, France

Location

Hôpital Edouard Herriot

Lyon, France

Location

Hôpital Saint-Eloi

Montpellier, France

Location

Chu Nimes

Nîmes, 30900, France

Location

Hôpital Saint-Antoine

Paris, France

Location

CHRU Nancy

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Ludovic Caillo

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ludovic Caillo

CONTACT

06.70.88.85.07; ludovic.caillo@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 14, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

FR (6)