Advanced Pancreatic Cancer and Cholangiocarcinoma, Inoperable Malignant Biliary Obstruction, Lumen Apposing Metal Stents, Malignant Biliary Obstruction
Conditions
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
Interventions
DEVICEFully 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
DEVICEDouble 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
Sponsors
Waikato Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of LAMS placement. | 1 day | Whether the LAMS stent is able to be successfully placed in the procedure |
| Technical success of second stent-in-stent placement | 1 day | Whether the second stent (either FCSEMS or DPS) is able to be placed successfully |
| Clinical success of biliary drainage (evaluated at weeks 1, 2, 4, 12, and 26 using bilirubin and liver enzymes). | weeks 1, 2, 4, 12, and 26 | whether biliary drainage has been successful based on biochemical blood tests |
| Re-intervention rate | 26 weeks | blockage of the LAMS stent requiring repeat procedure(s) as evidenced by clinical, biochemical evidence, and/or radiological evidence of biliary obstruction |
Countries
New Zealand
Contacts
Primary ContactFrank Weilert, BSc, MBBCh
Outcome results
None listed