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EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)
NCT06653192 · Hospital Universitari de Bellvitge
In plain English
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Official title
Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction: An Open-label, Multicenter Randomized Trial (CARPEDIEM Trial)
About this study
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 potentially surgical patients is still limited.
Recent retrospective study (Janet J et al, Ann Surg Oncol 2023) and two recent meta-analysis (Barbosa E et al, GIE 2024; Gopakumar H et al, AM J Gastr 2024; both with \> 500 cases) found that EUS-CDS group had significantly less technical failure rate and less postprocedure pancreatitis rate.
Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing those rates (technical failure, postprocedure pancreatitis) when compared to ERCP in MDBO in potentially surgical patients with resectable and borderline disease.
Eligibility criteria
Inclusion Criteria:
* Malignant distal biliary obstruction diagnosed in patient considered RESECTABLE or POTENTIALLY RESECTABLE/BORDERLINE 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 directly resectable, 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.
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-05-06
Estimated completion: 2028-05-06
Last updated: 2025-07-29
Interventions
Procedure: Endoscopic biliary drainageDevice: Self-expandable metallic stent (SEMS)Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
Primary outcomes
- • Postprocedure surgical challenges rate (1 day to 24 months)
Sponsor
Hospital Universitari de Bellvitge · other
With: Hospital Mutua de Terrassa, Hospital Clínico Universitario de Valencia, Hospital General Universitario de Alicante, Hospital General Universitario de Castellón, Complejo Hospitalario Universitario de Santiago, University Hospital Virgen de las Nieves, Complejo Hospitalario de Navarra, Hospital de Sant Pau, University of Salamanca
Contacts & investigators
ContactMaria Puigcerver-Mas, MD · contact · mariapuigcervermas@gmail.com · +34 687332007
ContactJoan B Gornals, MD,PhD · contact · jgornals@bellvitgehospital.cat · +34 932607682
InvestigatorJoan B Gornals, PhD · principal_investigator, Hospital Universitari de Bellvitge, SEED
All locations (10)
Hospital General Universitario Dr. BalmisNot Yet Recruiting
Alicante, Alicante, Spain
Hospital General Universitario de CastellónNot Yet Recruiting
Castellon, Castellón, Spain
Hospital de Sant Pau i de la Santa CreuNot Yet Recruiting
Barcelona, Catalonia, Spain
Hospital Universitari de BellvitgeRecruiting
Hospitalet de Llobregat, Barcelona, Catalonia, Spain
Hospital Mútua de TerrassaRecruiting
Terrassa, Catalonia, Spain
Hospital Clínico Universitario de SantiagoNot Yet Recruiting
Santiago de Compostela, Galicia, Spain
Hospital Universitario Virgen de las NievesNot Yet Recruiting
Granada, Granada, Spain
Complejo Hospitalario de NavarraNot Yet Recruiting
Pamplona, Navarre, Spain
Hospital Clínico Universitario de SalamancaNot Yet Recruiting
Salamanca, Salamanca, Spain
Hospital Clínico Universitario de ValenciaNot Yet Recruiting
Valencia, Valencia, Spain