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Clinical Trial NCT07115420 (Opti-LAMS) for Malignant Biliary Obstruction, Advanced Pancreatic Cancer and Cholangiocarcinoma, Inoperable Malignant Biliary Obstruction, Lumen Apposing Metal Stents is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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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 (Opti-LAMS) 100
Clinical Trial NCT07115420 (Opti-LAMS) is an interventional study for Malignant Biliary Obstruction, Advanced Pancreatic Cancer and Cholangiocarcinoma, Inoperable Malignant Biliary Obstruction, Lumen Apposing Metal Stents and is currently not yet recruiting. Enrollment is planned to begin on 1 September 2025 and continue until the study accrues 100 participants. Led by Waikato Hospital, this study is expected to complete by 1 March 2028. The latest data from ClinicalTrials.gov was last updated on 11 August 2025.
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 me...
Show MoreOfficial 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
Conditions
Malignant Biliary ObstructionAdvanced Pancreatic Cancer and CholangiocarcinomaInoperable Malignant Biliary ObstructionLumen Apposing Metal StentsOther Study IDs
- Opti-LAMS
- RD025065
NCT ID Number
Start Date (Actual)
2025-09
Last Update Posted
2025-08-11
Completion Date (Estimated)
2028-03
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalFully 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 comple...Show More | 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 comple...Show More |
Active ComparatorDouble 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 | 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 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Technical success of LAMS placement. | Whether the LAMS stent is able to be successfully placed in the procedure | 1 day |
Technical success of second stent-in-stent placement | Whether the second stent (either FCSEMS or DPS) is able to be placed successfully | 1 day |
Clinical success of biliary drainage (evaluated at weeks 1, 2, 4, 12, and 26 using bilirubin and liver enzymes). | whether biliary drainage has been successful based on biochemical blood tests | weeks 1, 2, 4, 12, and 26 |
Re-intervention rate | blockage of the LAMS stent requiring repeat procedure(s) as evidenced by clinical, biochemical evidence, and/or radiological evidence of biliary obstruction | 26 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Waikato HospitalStudy Central Contact
Contact: Frank Weilert, BSc, MBBCh, +6421417473, [email protected]
1 Study Locations in 1 Countries
Waikato Hospital, Te Whatu Ora Health New Zealand Waikato, Hamilton, New Zealand
Frank Weilert, BSc, MBBCh, FRACP and FASGE, Contact, +6421417473, [email protected]
Tara Fox, MBChB, Sub-Investigator
Nick Dalkie, MBChB, Sub-Investigator
Jerry YL Chin, Sub-Investigator
Paul Fockens, Sub-Investigator