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

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 6, 2025

Primary Completion Date

June 6, 2027

Study Completion Date

May 6, 2028

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 (10)

12004

NOT_YET_RECRUITING

Hospital General Universitario de Castellón, Castellon

15706

NOT_YET_RECRUITING

Hospital Clínico Universitario de Santiago, Santiago de Compostela

18014

NOT_YET_RECRUITING

Hospital Universitario Virgen de las Nieves, Granada

31006

NOT_YET_RECRUITING

Complejo Hospitalario de Navarra, Pamplona

37007

NOT_YET_RECRUITING

Hospital Clínico Universitario de Salamanca, Salamanca

46010

NOT_YET_RECRUITING

Hospital Clínico Universitario de Valencia, Valencia

03010

NOT_YET_RECRUITING

Hospital General Universitario Dr. Balmis, Alicante

08041

NOT_YET_RECRUITING

Hospital de Sant Pau i de la Santa Creu, Barcelona

08907

RECRUITING

Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Barcelona

08221

RECRUITING

Hospital Mútua de Terrassa, Terrassa

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 General Universitario de Castellón

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