Improving a Bile Duct Drainage Procedure in Patients With Inoperable Cancer Blocking the Bile Ducts: Comparing Two Types of Endoscopically Placed Internal Stents to Prevent Blockage of a Lumen Apposing Metal Stent

NANot yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

March 31, 2028

Conditions
Malignant Biliary ObstructionAdvanced Pancreatic Cancer and CholangiocarcinomaInoperable Malignant Biliary ObstructionLumen Apposing Metal Stents
Interventions
DEVICE

Fully covered self expanding metal stent (FCSEMS) within LAMS

In those randomised to FCSEMS, size will depend on the size of the LAMS with a 6mm LAMS to be stented with 8mm diameter FCSEMS and an 8mm LAMS to be stented with a 10mm FCSEMS, 4cm or 6cm length. The aim is to have at least 3cm of FCSEMS in the duodenal lumen If unable to place FCSEM through LAMS, crossover to DPS is allowed with plan for both intention to treat and per protocol analysis to be undertaken after completion of the study

DEVICE

Double pigtail stent (DPS) within LAMS

In those randomised to DPS, a double pigtail will be placed through the LAMS. The size of the stents will be left to the discretion of the proceduralist though 7Fr calibre with 7cm length is the recommended size

Trial Locations (1)

Unknown

Waikato Hospital, Te Whatu Ora Health New Zealand Waikato, Hamilton

All Listed Sponsors
lead

Waikato Hospital

OTHER