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

Treatment of Malignant Distal Biliary Obstruction - a Randomized Study

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.

Study Overview

• Status: Unknown
• Conditions: Biliary Stricture; Cancer of the Pancreas; Bile Duct Obstruction, Extrahepatic; Cancer of the Bile Duct
• Intervention / Treatment: Device: Biliary stent

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc M Bernon, MBBCh; Phone Number: +27 (0)21 404 3042; Email: mm.bernon@uct.ac.za

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7925
      • Recruiting
      • Groote Schuur Hospital
      • Contact: Marc M Bernon, MBBCh; Phone Number: +27 (0)21 404 3042; Email: mm.bernon@uct.ac.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Multiple Plastic Stents; Patients will receive two 8.5Fr Platic biliary stents placed side by side across the biliary stricture.	Device: Biliary stent; Palliation of malignant biliary obstruction
ACTIVE_COMPARATOR: Self-expandable Metal Stents; Patients will receive a fully covered Self-expandable Metal Stents (10mm) across the biliary stricture	Device: Biliary stent; Palliation of malignant biliary obstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients without stent failure	Number of patients without Stent failure (jaundice) or death with a patent stent	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Cape Town

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: January 26, 2019
• First Submitted That Met QC Criteria: January 26, 2019
• First Posted (ACTUAL): January 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Biliary Tract Diseases; Pancreatic Diseases; Bile Duct Diseases; Biliary Tract Neoplasms; Pancreatic Neoplasms; Cholestasis; Cholestasis, Extrahepatic; Bile Duct Neoplasms
• Other Study ID Numbers: 661/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No