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

Not Applicable

Not yet recruiting

• Conditions: Malignant Biliary Obstruction; Pancreatic Cancer; Biliary Tract Neoplasms

• Registration Number: NCT06653192
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief 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.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-15
• Study First Submitted: 2024-10-19
• Study First Submitted QC: 2024-10-19
• Last Update Submitted: 2024-10-19
• Study First Posted: 2024-10-22
• Last Update Posted: 2024-10-22
• Primary Completion: 2026-10-15
• Study Completion: 2027-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postprocedure surgical challenges rate	1 day to 24 months	Percentage of biliary drainage technical failure and/or percentage of postprocedure acute pancreatitis.

Secondary Outcome Measures

Name	Time	Method
Clinical success	14 days after BD	In jaundice: decreasing \> 50% of bilirrubin or normalization of bilirrubin levels 14 days after endoscopic procedure.
AE - biliary drainage	0 to 30 days after BD	Adverse events rate related to biliary drainage according to the AGREE classification
AE - surgery	0 to 90 days after surgery	Adverse events rate related to surgery according to the Claiven and Dindo classification.
Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP)	1 day to 6 months	Number of days between intervention (T1-biliary drainage) and surgery
Rate of surgery	1 to 24 months	Rate of patients that undergo to surgery

Trial Locations

Locations (10)

Hospital General Universitario de Castellón; 🇪🇸 Castelló de la Plana, 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

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital General Universitario Dr. Balmis; 🇪🇸 Alicante, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Clínico Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain