Health TrialsbyHealthPanel

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

ConditionsMalignant Biliary ObstructionAdvanced Pancreatic Cancer and CholangiocarcinomaInoperable Malignant Biliary ObstructionLumen Apposing Metal Stents
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWaikato Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Previous biliary stenting or surgery precluding EUS-CDS.

Inability to provide informed consent.

Pregnancy.

Significant coagulopathy that is not correctable.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fully covered self expanding metal stent (FCSEMS) within LAMS

    Device

    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 LAMS

    Device

    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 groups

100 Participants
are divided into 2 treatment groups
Group A: Fully covered self expanding metal stent (FCSEMS) within LAMSExperimental treatment 1 intervention
Group B: Double pigtail stent (DPS) within LAMSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Technical success of LAMS placement.

Whether the LAMS stent is able to be successfully placed in the procedure

Time frame
1 day
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Waikato Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: