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

NCT ID: NCT07115420

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-03-31

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Fully covered self expanding metal stent (FCSEMS) within LAMS

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

Double pigtail stent (DPS) within LAMS

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Waikato Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Waikato Hospital, Te Whatu Ora Health New Zealand Waikato

Hamilton, , New Zealand

Countries

New Zealand

Central Contacts

Frank Weilert, BSc, MBBCh

Role: CONTACT

frank.weilert@waikatodhb.health.nz

+6421417473

Facility Contacts

Frank Weilert, BSc, MBBCh, FRACP and FASGE

Role: primary

frank.weilert@waikatodhb.health.nz

+6421417473

Other Identifiers

RD025065

Identifier Type: -

Identifier Source: org_study_id