An interventional study of Fully covered self expanding metal stent (FCSEMS) within LAMS and Double pigtail stent (DPS) within LAMS in Malignant Biliary Obstruction, Advanced Pancreatic Cancer and Cholangiocarcinoma and Inoperable Malignant Biliary Obstruction, sponsored by Waikato Hospital. Not yet recruiting at 1 site in New Zealand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Waikato Hospital · Not applicable, Interventional, and Prevention
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:
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
824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 623 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Waikato Hospital is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
Technical success of LAMS placement.
Whether the LAMS stent is able to be successfully placed in the procedure
Time frame: 1 day
Technical success of second stent-in-stent placement
Whether the second stent (either FCSEMS or DPS) is able to be placed successfully
Time frame: 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
Time frame: 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
Time frame: 26 weeks
Plan to share: Yes — only IPD used in the results publication
Supporting information: Study protocol, Informed consent form, Clinical study report
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
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Sep 2027, 24 months later.
Of 66 non-industry interventional studies with no phase under Cholangiocarcinoma, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 28. This study's planned 24 months is below that.
Counting every sponsor, half of 67 studies reached it within 43 months; a quarter within 28.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Waikato Hospital