EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)

NANot yet recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

June 1, 2026

Study Completion Date

May 1, 2027

Conditions
Malignant Biliary ObstructionPancreatic CancerBiliary Tract Neoplasms
Interventions
PROCEDURE

Endoscopic biliary drainage

Decompression of the bile duct by endoscopic aproach.

DEVICE

Self-expandable metallic stent (SEMS)

"Self-expandable metallic stent (SEMS) deployment:~* Covering: Uncovered or Partially Covered. Non covered if gallbladder is present.~* Size: 10x40mm or 10x60mm or 10x80mm."

DEVICE

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

"Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment:~* LAMS size: 6x8mm or 8x8mm. Consider 10x10mm if bile duct \> 18mm.~* DPPS size: 7Fr x 3-7cm."

Trial Locations (1)

08907

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat

All Listed Sponsors
collaborator

Hospital Mutua de Terrassa

OTHER

collaborator

Hospital Clínico Universitario de Valencia

OTHER

collaborator

Hospital General Universitario de Alicante

OTHER

collaborator

Hospital Universitario Ramon y Cajal

OTHER

collaborator

Hospital General Universitario de Castellón

OTHER

collaborator

Hospital Álvaro Cunqueiro

OTHER

collaborator

Complejo Hospitalario Universitario de Santiago

OTHER

collaborator

University Hospital Virgen de las Nieves

OTHER

collaborator

Complejo Hospitalario de Navarra

OTHER

collaborator

Hospital de Sant Pau

OTHER

collaborator

University of Salamanca

OTHER

lead

Hospital Universitari de Bellvitge

OTHER

NCT06375954 - EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial) | Biotech Hunter | Biotech Hunter