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

Treatment of Malignant Distal Biliary Obstruction - a Randomized Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03821025

Enrollment

150

Registered

2019-01-29

Start date

2019-01-01

Completion date

2021-12-31

Last updated

2019-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEBiliary stent

Palliation of malignant biliary obstruction

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Overall survival	12 months	Number of patietns alive in each group at 12 months
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

Countries

South Africa

Contacts

Primary ContactMarc M Bernon, MBBCh

mm.bernon@uct.ac.za+27 (0)21 404 3042

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026