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

Biliary Stricture Clinical Trial

Official title:

Treatment of Malignant Distal Biliary Obstruction - a Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821025
• Other study ID #: 661/2017
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2019
• Source: University of Cape Town
• Contact: Marc M Bernon, MBBCh
• Phone: +27 (0)21 404 3042
• Email: mm.bernon[@]uct.ac.za
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Bile Duct Obstruction, Extrahepatic
• Biliary Stricture
• Cancer of the Bile Duct
• Cancer of the Pancreas
• Cholestasis
• Cholestasis, Extrahepatic
• Pancreatic Neoplasms

Intervention

Device:
• Biliary stent
Palliation of malignant biliary obstruction

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital	Cape Town	Western Cape

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients without stent failure	Number of patients without Stent failure (jaundice) or death with a patent stent	12 months
Secondary	Overall survival	Number of patietns alive in each group at 12 months	12 months
Secondary	Stent deployment failure	Number of patients in whom there was failure to deploy the assigned stent(s) after randomisation	During procedure
Secondary	Cost	The differance in treatment costs between the two groups, measured in USD	12 months