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EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial) | Clinical Trials | Clareo Health

RECRUITINGNA

EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)

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)

NCT06653192•Hospital Universitari de Bellvitge

View on ClinicalTrials.gov

Summary

The aim of this clinical trial is to evaluate the biliary drainage technical failure rate and/or the postprocedure acute pancreatitis rate between EUS-CDS vs ERCP procedures in patients with distal malignant biliary obstruction.

Detailed Description

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+1 more criteria

Locations (10)

Hospital General Universitario Dr. Balmis

Alicante, Alicante, Spain

Hospital General Universitario de Castellón

Castellon, Castellón, Spain

Hospital de Sant Pau i de la Santa Creu

Barcelona, Catalonia, Spain

Hospital Universitari de Bellvitge

Hospitalet de Llobregat, Barcelona, Catalonia, Spain

Hospital Mútua de Terrassa

Terrassa, Catalonia, Spain

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Galicia, Spain

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Hospital Clínico Universitario de Salamanca

Salamanca, Salamanca, Spain

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Key Dates

Start Date

May 6, 2025

Primary Completion Date

June 6, 2027

Completion Date

May 6, 2028

Last Updated

July 29, 2025

Enrollment

120

ESTIMATED participants

Conditions

Malignant Biliary ObstructionPancreatic CancerBiliary Tract Neoplasms

Interventions

Endoscopic biliary drainage

PROCEDURE

Self-expandable metallic stent (SEMS)

DEVICE

Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)

DEVICE

Contacts

Maria Puigcerver-Mas, MD

CONTACT

+34 687332007 mariapuigcervermas@gmail.com

Joan B Gornals, MD,PhD

CONTACT

+34 932607682 jgornals@bellvitgehospital.cat

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)

Inclusion Criteria

Exclusion Criteria

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