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 (Opti-LAMS)

Waikato Hospital

Status: Not yet enrolling

Conditions: Lumen Apposing Metal Stents; Malignant Biliary Obstruction; Advanced Pancreatic Cancer and Cholangiocarcinoma; Inoperable Malignant Biliary Obstruction

Treatments: Device: Double pigtail stent (DPS) within LAMS; Device: Fully covered self expanding metal stent (FCSEMS) within LAMS

Study type: Interventional

Funder types: Other

Identifiers

NCT07115420

RD025065

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Fully covered self expanding metal stent (FCSEMS) within LAMS

Experimental group

Description:

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

Treatment:

Device: Fully covered self expanding metal stent (FCSEMS) within LAMS

Double pigtail stent (DPS) within LAMS

Active Comparator group

Description:

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:

Device: Double pigtail stent (DPS) within LAMS