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.
Study Type
OBSERVATIONAL
Enrollment
300
Choice of modalities: ERCP, EUS-guided gallbladder drainage (EUS-GBD), EUS-guided choledochoduodenostomy (EUS-CDS), and EUS-guided hepaticogastrostomy (EUS-HGS)
CHU Dupuytren
Limoges, France
Hôpital Edouard Herriot
Lyon, France
Hôpital Saint-Eloi
Montpellier, France
Chu Nimes
Nîmes, France
Hôpital Saint-Antoine
Paris, France
CHRU Nancy
Vandœuvre-lès-Nancy, France
Biliary stent dysfunction between different endoscopic drainage modalities
Yes/no, according to Guidelines on Reporting Outcomes in Biliary Drainage Trials
Time frame: Month 12
Technical success rate of biliary stent placement with immediate visualization of biliary flow during the procedure between different endoscopic drainage modalities
Yes/no, where stent malposition or incomplete deployment requiring conversion or rescue maneuvers will not be considered technical successes.
Time frame: Month 12
Clinical success
Yes/no, measured as reduction of ≥50% in total bilirubin level compared to the pre-procedural value within 2 weeks of the index procedure, or achieving a total bilirubin level of less than 25% of the pre-procedural value within 6 weeks
Time frame: Month 12
Use of advanced cannulation techniques versus endoscopic ultrasound (EUS)-guided techniques in cases of difficult ERCP
Yes/no for use of: double-guidewire technique, precut, infundibulotomy, other
Time frame: Month 12
Segment showing highest drainage efficacy
Segment (II or III) with best bilirubin levels (µmol/L)
Time frame: Month 12
Tumor stage
TNM staging
Time frame: Month 12
Tumor size
cm
Time frame: Month 12
Tumor invasion of the cystic-common bile duct junction
Yes/no
Time frame: Month 12
Distance between the tumor and the cystic-common bile duct junction
mm
Time frame: Month 12
Physician experience
Classed as: resident, senior registrar/assistant, junior attending (\<500 procedures), or experienced attending (\>500 procedures)
Time frame: Month 12
Location of stenosis
Classed as: pylorus, D1, D2, D3, D4, jejunum, or multiple segments
Time frame: Month 12
length of stenosis
cm
Time frame: Month 12
tumor invasion of the papilla
yes/no
Time frame: Month 12
Clinical success rate
Yes/no, where success is classed as ≥50% reduction in total bilirubin levels compared to the pre-procedural value within 2 weeks of the index procedure, or achieving a total bilirubin level below 25% of the pre-procedural value within 6 weeks.
Time frame: Month 12
Bilirubin levels
µmol/l
Time frame: Day 0, Day 14, Day 45, Month 6, and Month 12.
New biliary drainage procedure
Yes/no
Time frame: Month 12
Interval between the 1st and 2nd procedure if necessary
Days
Time frame: Month 12
Re-intervention strategy/types of re-intervention
Classed as: ERCP, HGS, CGS, CDS, radiological drainage
Time frame: Month 12
Time to initiation of chemotherapy
Measured from day of the endoscopic procedure and Day 1 of chemotherapy
Time frame: Month 12
Proportion of patients with a surgical plan
Yes/no
Time frame: Month 12
Proportion of patients with a chemotherapy plan
Yes/no
Time frame: Month 12
Proportion of patients with a palliative care plan
Yes/no
Time frame: Month 12
Proportion of patients for whom surgery performed
Yes/no
Time frame: Month 12
Proportion of patients for whom chemotherapy performed
Yes/no
Time frame: Month 12
surgical complication related to the prior endoscopic procedure
Yes/no
Time frame: Month 12
Technique used in cases of duodenal stenosis
Classed as: ERCP, HGS, CDS, CGS, radiological drainage
Time frame: Month 12
CGS drainage technique
Classed as cholecystogastric or cholecystoduodenal
Time frame: Month 12
Cumulative incidence of adverse events
Number
Time frame: Month 12
Timing of adverse events
Classed as: early: \<30 days; late: ≥30 days
Time frame: Month 12
Causality of adverse events
Classed as: procedure-related, disease-related, or unrelated
Time frame: Month 12
Severity of adverse events
According to the AGREE classification (grades I to V) and the ASGE lexicon (Nass et al. 2022); - Specifically reported adverse events will include: cholangitis, bile leak, hemorrhage, pneumoperitoneum, perforation, stent migration, stent occlusion, cholecystitis (EUS-GBD arm), and buried stent syndrome. Chemotherapy interruption directly attributable to a drainage-related event will be documented as an indirect adverse event.
Time frame: Month 12
Overall survival between different endoscopic drainage modalities
Time frame: Month 12
Survival free from biliary re-intervention between different endoscopic drainage modalities
Time frame: Month 12
Mean total cost per patient
Including the initial procedure, expressed in euros; calculated from the perspective of the healthcare system (hospitals + health insurance) and including the costs of hospitalizations, transport, and endoscopic procedures (initial procedure and any re-interventions).
Time frame: Month 12
Proportion of operable or borderline patients who were surgically explored
Defined as the actual performance of a laparotomy or laparoscopy with the aim of pancreatic resection
Time frame: Month 12
Proportion of operable or borderline patients who were resected
Defined as the performance of a pancreatic resection procedure
Time frame: Month 12
Need for an associated vascular procedure
yes/no (including venous or arterial resection and/or reconstruction)
Time frame: Month 12
Conversion to laparotomy in patients initially operated on via a minimally invasive approach
Yes/no
Time frame: Month 12
Margin status
Resection margin status: R0 / R1
Time frame: Month 12
Lymph node dissection
Number of lymph nodes analyzed: continuous quantitative variable (absolute number)
Time frame: Month 12
Postoperative pathological stage (ypTNM)
measured according to the classification in effect at the time of surgery
Time frame: Month 12
Presence of severe morbidity
Occurrence of at least one severe postoperative complication, defined as: Clavien-Dindo ≥ III
Time frame: Month 12
30-day mortality
Yes/no
Time frame: Day 30
90-day mortality
Yes/no
Time frame: Day 90
Feasibility rate
Percentage of centers that enrolled at least 5 patients within the scheduled timeframe
Time frame: Month 24
Enrollment rate for eligible patients
Calculated as: number of patients enrolled / number of eligible patients identified
Time frame: Month 12
Data completeness rate for the minimum variables required for the future registry
Percentage
Time frame: Month 24
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