Comparing two methods for draining bile in patients with malignant biliary obstruction
Multicenter Study of EUS-guided Gallbladder Drainage vs Choledochoduodenostomy as First Line in Malignant Distal Obstruction in Palliative Patients (CARPEGIEM Trial): an Open-label, Randomized Controlled Clinical Trial
This study is testing whether a new way to drain bile using a special stent is safer than a traditional method for patients with bile duct blockages due to cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Locations | 10 sites (L'Hospitalet de Llobregat, Barcelona and 9 other locations) |
| Trial ID | NCT06375967 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the technical, clinical, and safety outcomes of using a lumen-apposing metal stent (LAMS) versus a coaxial double-pigtail plastic stent (DPS) in endoscopic procedures for managing malignant biliary obstruction in palliative patients. The study aims to determine if EUS-guided gallbladder drainage (EUS-GBD) offers safety benefits over EUS-guided choledochoduodenostomy (EUS-CDS) while maintaining similar success rates. Participants will be monitored for outcomes related to biliary drainage effectiveness and adverse events. The trial builds on previous studies that have shown promising results for both techniques in similar patient populations.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with malignant distal biliary obstruction who are considered palliative and require biliary drainage.
Not a fit: Patients with benign or uncertain etiology of biliary strictures or those with resectable tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and effective first-line treatment option for patients with malignant biliary obstruction.
How similar studies have performed: Previous studies have shown success with similar approaches, but this trial is among the first to directly compare EUS-GBD and EUS-CDS in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Malignant distal biliary obstruction diagnosed in patient considered PALIATIVE with biliary drainage indication. * Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histological confirmation is not mandatory) * Patient capable of understanding and/or singning the informed consent. * Patient who understands the type of study and will comply with all follow-up tests throughout its duration Exclusion Criteria: * Pregnancy or lactation. * Severe coagulation disorder: INR \> 1.5 non correctable with plasma administration and/or platelet count \< 50.000/mm3. * Previous cholecistectomy or gallblader perforation. * Tumoral obstruction of cystic duct. * Multiple liver metastases affecting more than 30% of the liver parenchyma * Distal malignant biliary strictures in patients considered resectable or borderline. * Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum. * Patients with prior biliary stents or other biliary drainages (e.g., PTCD). * Altered intestinal anatomy due to prior surgery that prevents or hinders papillary access ______________ (e.g., gastric bypass, Billroth II, duodenal switch, Roux-en-Y). * Gastric outlet obstruction. * Situations that do not allow for upper gastrointestinal endoscopy (e.g., esophageal stricture). * Patients with functional diversity, who lack the capacity to understand the nature and potential consequences of the study, except when a legal representative is available. * Patients incapable of maintaining follow-up appointments (lack of adherence). * Lack of informed consent.
Where this trial is running
L'Hospitalet de Llobregat, Barcelona and 9 other locations
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
- Hospital General Alicante — Alicante, Valencia, Spain (Not_yet_recruiting)
- Hospital Universitari de Castello — Castello, Valencia, Spain (Not_yet_recruiting)
- Hospital Santa Creu I Sant Pau — Barcelona, Spain (Active_not_recruiting)
- Hospital Virgen de Las Nieves — Granada, Spain (Not_yet_recruiting)
- Complejo Hospitalario de Pamplona — Pamplona, Spain (Active_not_recruiting)
- Hospital Santiago de Compostela — Santiago De Compostela, Spain (Active_not_recruiting)
- Hospital Mutua de Terrassa — Terrassa, Spain (Not_yet_recruiting)
- Hospital Clinic de Valencia — Valencia, Spain (Not_yet_recruiting)
- Hospital Cunqueiro de Vigo — Vigo, Spain (Active_not_recruiting)
Study contacts
- Principal investigator: Joan B Gornals Soler — Study Principal Investigator
- Study coordinator: Julia Escuer Turu, MD, Research fellow
- Email: carpegiem.trial@gmail.com
- Phone: 618272824
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.