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

Not Applicable

• Conditions: Biliary Stricture; Cancer of the Pancreas; Bile Duct Obstruction, Extrahepatic; Cancer of the Bile Duct
• Interventions: Device: Biliary stent

• Registration Number: NCT03821025
• Lead Sponsor: University of Cape Town

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-01-26
• Study First Submitted QC: 2019-01-26
• Study First Posted: 2019-01-29
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-20
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple Plastic Stents	Biliary stent	Patients will receive two 8.5Fr Platic biliary stents placed side by side across the biliary stricture.
Self-expandable Metal Stents	Biliary stent	Patients will receive a fully covered Self-expandable Metal Stents (10mm) across the biliary stricture

Primary Outcome Measures

Name	Time	Method
Number of patients without stent failure	12 months	Number of patients without Stent failure (jaundice) or death with a patent stent

Secondary Outcome Measures

Name	Time	Method
Stent deployment failure	During procedure	Number of patients in whom there was failure to deploy the assigned stent(s) after randomisation
Cost	12 months	The differance in treatment costs between the two groups, measured in USD
Overall survival	12 months	Number of patietns alive in each group at 12 months

Trial Locations

Locations (1)

Groote Schuur Hospital; 🇿🇦 Cape Town, Western Cape, South Africa