Malignant Biliary ObstructionOpti-LAMSNCT07115420
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
A study testing Fully covered self expanding metal stent (FCSEMS) within LAMS and Double pigtail stent (DPS) within LAMS in people with Malignant Biliary Obstruction and Advanced Pancreatic Cancer and Cholangiocarcinoma, run by Waikato Hospital at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Biliary Obstruction, Advanced Pancreatic Cancer and Cholangiocarcinoma, Inoperable Malignant Biliary Obstruction
- What is being tested?
- Fully covered self expanding metal stent (FCSEMS) within LAMS and Double pigtail stent (DPS) within LAMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNew Zealand
- Study dates
- Sep 2025to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand1 site
Waikato Hospital, Te Whatu Ora Health New Zealand Waikato
Hamilton
Frank Weilert, BSc, MBBCh, FRACP and FASGE, +6421417473, frank.weilert@waikatodhb.health.nz
Tara Fox, MBChB
About this study
Official 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
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.
Read more
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
- Being tested
- Fully covered self expanding metal stent (FCSEMS) within LAMS, Double pigtail stent (DPS) within LAMS
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully covered self expanding metal stent (FCSEMS) within LAMSDevice
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 LAMSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Double pigtail stent (DPS) within LAMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26 weeks
Secondary outcomes (4)
Technical success of LAMS placement.
Whether the LAMS stent is able to be successfully placed in the procedure
Measured: 1 day
Technical success of second stent-in-stent placement
Whether the second stent (either FCSEMS or DPS) is able to be placed successfully
Measured: 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
Measured: 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
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Biliary ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waikato Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115420
- Sponsor's protocol ID
- RD025065
- Acronym
- Opti-LAMS
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07115420
- Acronym / sponsor ID
- Opti-LAMS / RD025065
- Conditions
- Malignant Biliary Obstruction, Advanced Pancreatic Cancer and Cholangiocarcinoma, Inoperable Malignant Biliary Obstruction, Lumen Apposing Metal Stents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Waikato HospitalUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fully covered self expanding metal stent (FCSEMS) within LAMS | Experimental | Device: Fully covered self expanding metal stent (FCSEMS) within LAMSIn 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 | Active comparator | Device: Double pigtail stent (DPS) within LAMSIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fully covered self expanding metal stent (FCSEMS) within LAMSIn 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 LAMSIn 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 |
Primary outcome
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
4 secondary outcomes
Technical success of LAMS placement.
Time frame: 1 day
Technical success of second stent-in-stent placement
Time frame: 1 day
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
Re-intervention rate
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
Related trials for Malignant Biliary Obstruction
Active, not recruitingObservational study
A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage
Malignant Biliary Obstruction
Recruiting
Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)
Cholangiocarcinoma, Bile Duct Neoplasms
Recruiting
Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
Malignant Biliary Obstruction, Malignant Biliary Stricture
Not yet recruiting
Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Biliary Tract Neoplasms, Biliary Drainage
Active, not recruiting
Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents
Pancreatic Cancer Non-resectable, Bile Duct Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully covered self expanding metal stent (FCSEMS) within LAMS and Double pigtail stent (DPS) within LAMS in people with Malignant Biliary Obstruction and Advanced Pancreatic Cancer and Cholangiocarcinoma, run by Waikato Hospital at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank Weilert, BSc, MBBCh (+6421417473, frank.weilert@waikatodhb.health.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.