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

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

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

Treatments tested in this trial

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

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators