Self-expandable Metal Stents Versus Multiple Plastic Stents For Palliation Of Biliary Obstruction

Study Overview

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

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.

N/A

Bile Duct Obstruction, Extrahepatic
Cancer of the Pancreas
Cancer of the Bile Duct
Biliary Stricture

DEVICE: Biliary stent

661/2017

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-01-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-02-18
First Submitted that Met QC Criteria 2019-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-02-20
First Posted (ACTUAL) 2019-01-29	Results First Posted N/A	Last Verified 2019-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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

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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Marc M Bernon, MBBCh

Phone Number: +27 (0)21 404 3042

Email: mm.bernon@uct.ac.za

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record