EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

December 31, 2021

Study Completion Date

December 31, 2022

Conditions
Malignant Biliary Obstruction
Interventions
PROCEDURE

EUS-guided choledocho-duodenostomy

"The CBD would be identified by a linear echoendoscope and a suitable puncture site in the bulb of the duodenum would be located. The common bile duct would be punctured with a 19-gauge needle and the position would be confirmed by aspiration of bile and contrast injection. A 0.025 or 0.035 guide wire would be passed through the needle in to the CBD. A fully covered metal stent would then be inserted after track dilation."

PROCEDURE

Endoscopic retrograde cholangiopancreatography with covered metallic stent

After cannulation of the CBD, a cholangiography would be performed to assess the diameter of the CBD, the length and position of the biliary stricture. The endoscopist would decide on the appropriate size of SEMS to be placed. The stents should be visible from the duodenal lumen after deployment.

Trial Locations (6)

Unknown

Royal Prince Alfred Hospital, Sydney

The University of Leuven, Leuven

Chinese University of Hong Kong, Hong Kong

Aarhus University Hospital, Aarhus

Tokyo Medical University Hospital, Tokyo

Wakayama Medical University School of Medicine, Wakayama

All Listed Sponsors
collaborator

Tokyo Medical University

OTHER

collaborator

Kinki University

OTHER

lead

Chinese University of Hong Kong

OTHER

NCT03000855 - EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures | Biotech Hunter | Biotech Hunter