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

NCT07115420 | Not Yet Recruiting FDA Device

• 1 other identifier: RD025065
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Technical success of LAMS placement.

  1 day

• Technical success of second stent-in-stent placement

  1 day

• 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

• Re-intervention rate

  26 weeks

Study Arms (2)

Fully covered self expanding metal stent (FCSEMS) within LAMS

EXPERIMENTAL

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: Fully covered self expanding metal stent (FCSEMS) within LAMS

Double pigtail stent (DPS) within LAMS

ACTIVE COMPARATOR

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

Interventions

Fully covered self expanding metal stent (FCSEMS) within LAMS 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

Fully covered self expanding metal stent (FCSEMS) within LAMS

Double pigtail stent (DPS) within LAMS 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

Double pigtail stent (DPS) within LAMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Waikato Hospital: lead

Study Sites (1)

Waikato Hospital, Te Whatu Ora Health New Zealand Waikato

Hamilton, New Zealand

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Frank Weilert, BSc, MBBCh

CONTACT

+6421417473; frank.weilert@waikatodhb.health.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 3 months after time of publication for 5 years
• Access Criteria: Other researchers will be able to access the above documents but no identifying patient data. They will have to email the head investigator to request the information, citing the reason for the request, and the head investigator will decide whether to grant access to the information or not

Locations

NZ (1)