Back to results

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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

South Africa

Study Type

Interventional

Intervention

Biliary stent

About this trial

This is an interventional treatment trial for Bile Duct Obstruction, Extrahepatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

Groote Schuur HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Multiple Plastic Stents

Self-expandable Metal Stents

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of patients without stent failure

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

Secondary Outcome Measures

Overall survival

Number of patietns alive in each group at 12 months

Stent deployment failure

Number of patients in whom there was failure to deploy the assigned stent(s) after randomisation

Cost

The differance in treatment costs between the two groups, measured in USD

Full Information

NCT ID

NCT03821025

First Posted

January 26, 2019

Last Updated

February 18, 2019

Sponsor

University of Cape Town

1. Study Identification

Unique Protocol Identification Number

NCT03821025

Brief Title

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

Official Title

Treatment of Malignant Distal Biliary Obstruction - a Randomized Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cape Town

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Multiple Plastic Stents

Arm Type

Active Comparator

Arm Description

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

Arm Title

Self-expandable Metal Stents

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Biliary stent

Intervention Description

Palliation of malignant biliary obstruction

Primary Outcome Measure Information:

Title

Number of patients without stent failure

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Overall survival

Description

Number of patietns alive in each group at 12 months

Time Frame

12 months

Title

Stent deployment failure

Description

Number of patients in whom there was failure to deploy the assigned stent(s) after randomisation

Time Frame

During procedure

Title

Cost

Description

The differance in treatment costs between the two groups, measured in USD

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marc M Bernon, MBBCh

Phone

+27 (0)21 404 3042

mm.bernon@uct.ac.za

Facility Information:

Facility Name

Groote Schuur Hospital

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7925

Country

South Africa

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc M Bernon, MBBCh

Phone

+27 (0)21 404 3042

mm.bernon@uct.ac.za

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs