Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

August 9, 2023

Primary Completion Date

November 1, 2027

Study Completion Date

November 1, 2027

Conditions
Cholangiocarcinoma Non-resectableGall Bladder CancerLiver MetastasisMalignant Hilar Stricture
Interventions
PROCEDURE

Primary percutaneous stenting (PPS)

PPS bridging malignant hilar biliary obstruction with self-expandable uncovered metal stents without crossing the ampulla and without leaving an external drain. The procedure is performed by an interventional radiologist who has performed at least 5 PPS procedures.

PROCEDURE

Endoscopic biliary drainage

EBD according to the American Society for Gastrointestinal Endoscopy (ASGE) guidelines of 2021. The procedure is performed by a gastro-enterologist who is experienced in performing EBD in patients with a MHBO.

Trial Locations (1)

Unknown

Erasmus MC, Rotterdam

Sponsors
All Listed Sponsors
lead

Erasmus Medical Center

OTHER

collaborator

Dutch Cancer Society

OTHER

NCT06671418 - Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction | Biotech Hunter | Biotech Hunter