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

Study Overview

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

This study looks at the best way to treat bile duct blockage in people with advanced cancer that cannot be removed by surgery. A blocked bile duct can cause serious symptoms like yellowing of the skin (jaundice), infection, and pain. A common procedure called ERCP sometimes doesn't work in these patients. A newer method called EUS-guided choledochoduodenostomy (EUS-CDS) uses internal ultrasound to place a special metal tube (called a LAMS) to allow bile to drain. However, over time this stent can still become blocked. To reduce this risk, doctors can place a second stent inside the first. This study is comparing two types of these second stents: * A plastic stent (double pigtail stent or DPS) * A metal stent (fully covered self-expanding metal stent or FCSEMS) The study will include patients at Waikato Hospital. After the first stent is placed, they will be randomly assigned to receive either a DPS or FCSEMS. Patients will be followed for 6 months to see how well the stents work. The aim is to find out which approach keeps the bile duct open longer and reduces the need for further procedures or hospitalisation, helping improve care and comfort for people with advanced cancer

N/A

Malignant Biliary Obstruction
Advanced Pancreatic Cancer and Cholangiocarcinoma
Inoperable Malignant Biliary Obstruction
Lumen Apposing Metal Stents

DEVICE: Fully covered self expanding metal stent (FCSEMS) within LAMS
DEVICE: Double pigtail stent (DPS) within LAMS

RD025065

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-08-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-03
First Submitted that Met QC Criteria 2025-08-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-11
First Posted (ACTUAL) 2025-08-11	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 l	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 l
ACTIVE_COMPARATOR: 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	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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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 l

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 l

ACTIVE_COMPARATOR: 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

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

Primary Outcome Measures	Measure Description	Time Frame
To compare the incidence of stent dysfunction (defined as recurrent jaundice and/or cholangitis) in patients with malignant biliary obstruction receiving FCSEMS vs DPS stent-in-stent through LAMS		26 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Technical success of LAMS placement.	Whether the LAMS stent is able to be successfully placed in the procedure	1 day
Technical success of second stent-in-stent placement	Whether the second stent (either FCSEMS or DPS) is able to be placed successfully	1 day
Clinical success of biliary drainage (evaluated at weeks 1, 2, 4, 12, and 26 using bilirubin and liver enzymes).	whether biliary drainage has been successful based on biochemical blood tests	weeks 1, 2, 4, 12, and 26
Re-intervention rate	blockage of the LAMS stent requiring repeat procedure(s) as evidenced by clinical, biochemical evidence, and/or radiological evidence of biliary obstruction	26 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Frank Weilert, BSc, MBBCh

Phone Number: +6421417473

Email: frank.weilert@waikatodhb.health.nz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Age ≥18 years.
Radiologically or histologically proven malignant distal bile duct obstruction with unresectable or metastatic disease, including those who have already failed ERCP
Indication for biliary drainage with presence of obstructive jaundice biochemically and dilated biliary system on imaging.
Informed consent provided.
Common bile duct (CBD) size of at least 12mm on EUS imaging

Previous biliary stenting or surgery precluding EUS-CDS.
Inability to provide informed consent.
Pregnancy.
Significant coagulopathy that is not correctable.
Futility of intervention e.g. pre-terminal patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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