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

Not Applicable

Not yet recruiting

• Conditions: Malignant Biliary Obstruction; Advanced Pancreatic Cancer and Cholangiocarcinoma; Inoperable Malignant Biliary Obstruction; Lumen Apposing Metal Stents

• Registration Number: NCT07115420
• Lead Sponsor: Waikato Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-03
• Study First Submitted QC: 2025-08-03
• Last Update Submitted: 2025-08-03
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Study Start: 2025-09-01
• Primary Completion: 2027-09
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Waikato Hospital, Te Whatu Ora Health New Zealand Waikato; 🇳🇿 Hamilton, New Zealand