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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07115420
Registration number
NCT07115420
Ethics application status
Date submitted
3/08/2025
Date registered
11/08/2025
Date last updated
11/08/2025
Titles & IDs
Public title
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
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Scientific 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
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Secondary ID [1]
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RD025065
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Universal Trial Number (UTN)
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Trial acronym
Opti-LAMS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malignant Biliary Obstruction
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Advanced Pancreatic Cancer and Cholangiocarcinoma
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Inoperable Malignant Biliary Obstruction
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Lumen Apposing Metal Stents
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Condition category
Condition code
Cancer
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Biliary tree (gall bladder and bile duct)
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Fully covered self expanding metal stent (FCSEMS) within LAMS
Treatment: Devices - Double pigtail stent (DPS) within LAMS
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 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
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
Treatment: Devices: 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
Treatment: Devices: 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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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26 weeks
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Secondary outcome [1]
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Technical success of LAMS placement.
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Assessment method [1]
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Whether the LAMS stent is able to be successfully placed in the procedure
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Timepoint [1]
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1 day
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Secondary outcome [2]
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Technical success of second stent-in-stent placement
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Assessment method [2]
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Whether the second stent (either FCSEMS or DPS) is able to be placed successfully
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Timepoint [2]
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1 day
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Secondary outcome [3]
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Clinical success of biliary drainage (evaluated at weeks 1, 2, 4, 12, and 26 using bilirubin and liver enzymes).
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Assessment method [3]
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whether biliary drainage has been successful based on biochemical blood tests
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Timepoint [3]
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weeks 1, 2, 4, 12, and 26
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Secondary outcome [4]
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Re-intervention rate
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Assessment method [4]
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blockage of the LAMS stent requiring repeat procedure(s) as evidenced by clinical, biochemical evidence, and/or radiological evidence of biliary obstruction
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Timepoint [4]
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26 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/09/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2028
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Hamilton
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Funding & Sponsors
Primary sponsor type
Other
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Name
Waikato Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT07115420
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Frank Weilert, BSc, MBBCh
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Address
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Country
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Phone
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+6421417473
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
only IPD used in the results publication
Supporting document/s available: Study protocol, Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
3 months after time of publication for 5 years
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Available to whom?
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
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07115420
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