Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction in Resectable Disease: An Open-label, Multicenter Randomized Controlled Trial (CARPEDIEM-1 Trial)
| Registry | NCT06375928 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 44 (Estimated) |
| Sponsor | Hospital Universitari de Bellvitge (Other); collaborators: Hospital Mutua de Terrassa, Hospital Clínico Universitario de Valencia, Hospital General Universitario de Alicante, Hospital Universitario Ramon y Cajal, Hospital General Universitario de Castellón, Hospital Álvaro Cunqueiro, Complejo Hospitalario Universitario de Santiago, University Hospital Virgen de las Nieves, Complejo Hospitalario de Navarra, Hospital de Sant Pau, University of Salamanca |
| Conditions | Malignant Biliary Obstruction, Pancreatic Cancer Resectable, Biliary Tract Neoplasms |
| Interventions | Endoscopic biliary drainage, Self-expandable metallic stent (SEMS), Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) (Procedure, device) |
| Dates | start 2024-05-01 (estimated), primary completion 2026-02-01 (estimated), completion 2026-05-01 (estimated), first posted 2024-04-19, last updated 2024-04-19 |
| Locations | 1 site in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Malignant Biliary Obstruction All trials for Pancreatic Cancer Resectable All trials of Endoscopic biliary drainage All trials of Self-expandable metallic stent (SEMS)
The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction.
Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) has been extended as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). However, there are clinical trials which have compared it with ERCP as a first line treatment for MDBO in palliative patients, showing similar clinical and technical success and adverse events (AEs) rate between both techniques. Data about the benefit of this techique in resectable patients is still limited.
A recent retrospective study (Janet J et al, Ann Surg Oncol 2023) which included resectable patients, found that EUS-CDS group had significantly less delay (days) between biliary drainage and surgery than the ERCP group, with fewer endoscopy and surgery AEs.
Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing delay between biliary drainage when compared to ERCP in MDBO in resectable patients.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ERCP with SEMS | Active comparator | Procedure: Endoscopic biliary drainage; Device: Self-expandable metallic stent (SEMS) | Endoscopic retrograde cholangiopancreatography (ERCP) with deployment of a self-expandable metallic stent (SEMS). Gold standard in malignant distal biliary obstruction (MDBO) in current practice. ERCP technique: Cannulation with papillotome (advanced cannulation techniques are allowed). Sphincterotomy. Self-expandable metallic stent (SEMS) deployment. |
| EUS-CDS with LAMS-Pigtail | Experimental | Procedure: Endoscopic biliary drainage; Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) | Echoendoscopy-guided Choledochoduodenostomy (EUS-CDS) with deployment of a lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent throug LAMS. EUS-CDS technique: Diagnostic EUS. Classic or free-hand with preloaded guidewire choledochoduodenostomy with LAMS. Pneumatic dilation whithin LAMS is allowed. In case of bile duct < 15mm is mandatory the 'push' technique. Deployment of a pigtail coaxial to LAMS. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Malignant distal biliary obstruction diagnosed in patient considered RESECTABLE with biliary drainage indication: i) impaired hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of retrograde dilatation, of at least 12-mm axial diameter. * 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. * Distal malignant biliary strictures in patients considered borderline, non-surgical, unresectable, or palliative * 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). * Stenosis in the antral or duodenal region that prevents access to the duodenum and reaching the papilla. * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat, Barcelona, Catalonia | Spain |