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

NCT03821025 | Unknown

• 1 other identifier: 661/2017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of patients without stent failure

  Number of patients without Stent failure (jaundice) or death with a patent stent

  12 months

Secondary Outcomes (3)

• Overall survival

  12 months

• Stent deployment failure

  During procedure

• Cost

  12 months

Study Arms (2)

Multiple Plastic Stents

ACTIVE COMPARATOR

Patients will receive two 8.5Fr Platic biliary stents placed side by side across the biliary stricture.

Device: Biliary stent

Self-expandable Metal Stents

ACTIVE COMPARATOR

Patients will receive a fully covered Self-expandable Metal Stents (10mm) across the biliary stricture

Device: Biliary stent

Interventions

Biliary stent DEVICE

Palliation of malignant biliary obstruction

Multiple Plastic Stents; Self-expandable Metal Stents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (1)

Groote Schuur Hospital

Cape Town, Western Cape, 7925, South Africa

RECRUITING

MeSH Terms

Conditions

Cholestasis, Extrahepatic; Pancreatic Neoplasms; Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Neoplasms

Central Study Contacts

Marc M Bernon, MBBCh

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant

Study Record Dates

• First Submitted: January 26, 2019
• First Posted: January 29, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)