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NCT Number: NCT07115420

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Waikato Hospital, Te Whatu Ora Health New Zealand Waikato

Hamilton, New Zealand

Location contact

Frank Weilert, BSc, MBBCh, FRACP and FASGE

CONTACT

[email protected]

+6421417473

Jerry YL Chin

SUB_INVESTIGATOR

Nick Dalkie, MBChB

SUB_INVESTIGATOR

Paul Fockens

SUB_INVESTIGATOR

Tara Fox, MBChB

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

    Time frame: 26 weeks

Secondary outcomes

  1. Technical success of LAMS placement.

    Time frame: 1 day

    Whether the LAMS stent is able to be successfully placed in the procedure

  2. Technical success of second stent-in-stent placement

    Time frame: 1 day

    Whether the second stent (either FCSEMS or DPS) is able to be placed successfully

  3. Clinical success of biliary drainage (evaluated at weeks 1, 2, 4, 12, and 26 using bilirubin and liver enzymes).

    Time frame: weeks 1, 2, 4, 12, and 26

    whether biliary drainage has been successful based on biochemical blood tests

  4. Re-intervention rate

    Time frame: 26 weeks

    blockage of the LAMS stent requiring repeat procedure(s) as evidenced by clinical, biochemical evidence, and/or radiological evidence of biliary obstruction

Study contacts

Contact information is provided by the study sponsor or research team.

Frank Weilert, BSc, MBBCh

CONTACT

[email protected]

+6421417473

Sponsors and collaborators

Lead sponsor

Waikato Hospital

Other

Registry information

Official study title

Optimising EUS-guided Choledochoduodenostomy With Lumen Apposing Metal Stent With Stent in Stent Placement: a Randomised Study Between Double Pigtail Stent and Fully Covered Self-Expanding Metal Stent. The Opti-LAMS Study

Acronym: Opti-LAMS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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