Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction

University of Cape Town (UCT)

Status: Unknown

Conditions: Bile Duct Obstruction, Extrahepatic; Biliary Stricture; Cancer of the Bile Duct; Cancer of the Pancreas

Treatments: Device: Biliary stent

Study type: Interventional

Funder types: Other

Identifiers

NCT03821025

661/2017

Details and patient eligibility

About

A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18years of age or older
• informed consent obtained after oral and written information
• clinical data in accordance with a malignant bile duct obstruction
• imaging evidence: (ultrasonography (US), computed tomography (CT) or magnetic resonance imaging (MRI) shows signs of extrahepatic malignant common bile duct obstruction
• typical ERCP findings of a malignant common bile duct stenosis
• proximal margin of the bile duct stenosis ≥2 cm from the hepatic confluence
• bilirubin > 50 micromol/L
• radical surgery not deemed possible

Exclusion criteria

• patients with active hepatitis or other jaundice-causing hepatic diseases
• informed consent not obtained or patient unable to give informed consent
• patients with no understanding of English, Afrikaans or Xhosa where it is not possible to obtain informed consent
• metastasis with multiple significant intrahepatic stenosis causing blockage of one or more segments of the liver (liver metastasis otherwise not an exclusion criteria)
• the patient is a possible candidate for surgical resection
• suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations)
• the proximal end of the stenosis is < 2 cm from the hepatic confluence
• previous BII or Roux-en-Y gastric reconstruction
• significant duodenal obstruction making ERCP difficult
• previous bile duct stent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Multiple Plastic Stents

Active Comparator group

Description:

Patients will receive two 8.5Fr Platic biliary stents placed side by side across the biliary stricture.

Treatment:

Device: Biliary stent

Self-expandable Metal Stents

Active Comparator group

Description:

Patients will receive a fully covered Self-expandable Metal Stents (10mm) across the biliary stricture

Treatment:

Device: Biliary stent