Biliary Drainage, Endoscopic Ultrasound-Guided Drainage, Pancreatic Cancer
Conditions
Keywords
Gallbladder drainage, Choledochoduodenostomy
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.
Interventions
PROCEDUREEndoscopic drainage
Choice of modalities: ERCP, EUS-guided gallbladder drainage (EUS-GBD), EUS-guided choledochoduodenostomy (EUS-CDS), and EUS-guided hepaticogastrostomy (EUS-HGS)
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biliary stent dysfunction between different endoscopic drainage modalities | Month 12 | Yes/no, according to Guidelines on Reporting Outcomes in Biliary Drainage Trials |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate of biliary stent placement with immediate visualization of biliary flow during the procedure between different endoscopic drainage modalities | Month 12 | Yes/no, where stent malposition or incomplete deployment requiring conversion or rescue maneuvers will not be considered technical successes. |
| Clinical success | Month 12 | 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 |
| Use of advanced cannulation techniques versus endoscopic ultrasound (EUS)-guided techniques in cases of difficult ERCP | Month 12 | Yes/no for use of: double-guidewire technique, precut, infundibulotomy, other |
| Segment showing highest drainage efficacy | Month 12 | Segment (II or III) with best bilirubin levels (µmol/L) |
| Tumor stage | Month 12 | TNM staging |
| Tumor size | Month 12 | cm |
| Tumor invasion of the cystic-common bile duct junction | Month 12 | Yes/no |
| Distance between the tumor and the cystic-common bile duct junction | Month 12 | mm |
| Physician experience | Month 12 | Classed as: resident, senior registrar/assistant, junior attending (\<500 procedures), or experienced attending (\>500 procedures) |
| Location of stenosis | Month 12 | Classed as: pylorus, D1, D2, D3, D4, jejunum, or multiple segments |
| length of stenosis | Month 12 | cm |
| tumor invasion of the papilla | Month 12 | yes/no |
| Clinical success rate | Month 12 | 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. |
| Bilirubin levels | Day 0, Day 14, Day 45, Month 6, and Month 12. | µmol/l |
| New biliary drainage procedure | Month 12 | Yes/no |
| Interval between the 1st and 2nd procedure if necessary | Month 12 | Days |
| Re-intervention strategy/types of re-intervention | Month 12 | Classed as: ERCP, HGS, CGS, CDS, radiological drainage |
| Time to initiation of chemotherapy | Month 12 | Measured from day of the endoscopic procedure and Day 1 of chemotherapy |
| Proportion of patients with a surgical plan | Month 12 | Yes/no |
| Proportion of patients with a chemotherapy plan | Month 12 | Yes/no |
| Proportion of patients with a palliative care plan | Month 12 | Yes/no |
| Proportion of patients for whom surgery performed | Month 12 | Yes/no |
| Proportion of patients for whom chemotherapy performed | Month 12 | Yes/no |
| surgical complication related to the prior endoscopic procedure | Month 12 | Yes/no |
| Technique used in cases of duodenal stenosis | Month 12 | Classed as: ERCP, HGS, CDS, CGS, radiological drainage |
| CGS drainage technique | Month 12 | Classed as cholecystogastric or cholecystoduodenal |
| Cumulative incidence of adverse events | Month 12 | Number |
| Timing of adverse events | Month 12 | Classed as: early: \<30 days; late: ≥30 days |
| Causality of adverse events | Month 12 | Classed as: procedure-related, disease-related, or unrelated |
| Severity of adverse events | Month 12 | 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. |
| Overall survival between different endoscopic drainage modalities | Month 12 | — |
| Survival free from biliary re-intervention between different endoscopic drainage modalities | Month 12 | — |
| Mean total cost per patient | Month 12 | 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). |
| Proportion of operable or borderline patients who were surgically explored | Month 12 | Defined as the actual performance of a laparotomy or laparoscopy with the aim of pancreatic resection |
| Proportion of operable or borderline patients who were resected | Month 12 | Defined as the performance of a pancreatic resection procedure |
| Need for an associated vascular procedure | Month 12 | yes/no (including venous or arterial resection and/or reconstruction) |
| Conversion to laparotomy in patients initially operated on via a minimally invasive approach | Month 12 | Yes/no |
| Margin status | Month 12 | Resection margin status: R0 / R1 |
| Lymph node dissection | Month 12 | Number of lymph nodes analyzed: continuous quantitative variable (absolute number) |
| Postoperative pathological stage (ypTNM) | Month 12 | measured according to the classification in effect at the time of surgery |
| Presence of severe morbidity | Month 12 | Occurrence of at least one severe postoperative complication, defined as: Clavien-Dindo ≥ III |
| 30-day mortality | Day 30 | Yes/no |
| 90-day mortality | Day 90 | Yes/no |
| Feasibility rate | Month 24 | Percentage of centers that enrolled at least 5 patients within the scheduled timeframe |
| Enrollment rate for eligible patients | Month 12 | Calculated as: number of patients enrolled / number of eligible patients identified |
| Data completeness rate for the minimum variables required for the future registry | Month 24 | Percentage |
Countries
France
Contacts
CONTACTLudovic Caillo
PRINCIPAL_INVESTIGATORLudovic Caillo
Centre Hospitalier Universitaire de Nīmes
Outcome results
None listed