Bile Duct Obstruction, ExtrahepaticNCT03821025
Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction
A study testing Biliary stent in people with Bile Duct Obstruction, Extrahepatic and Cancer of the Pancreas, run by University of Cape Town at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Obstruction, Extrahepatic, Cancer of the Pancreas, Cancer of the Bile Duct
- What is being tested?
- Biliary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site, 1 recruiting
- Recruiting
Groote Schuur Hospital
Cape Town, Western Cape, 7925
Marc M Bernon, MBBCh, +27 (0)21 404 3042, mm.bernon@uct.ac.za
About this study
Official title: Treatment of Malignant Distal Biliary Obstruction - a Randomized Study
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
- Being tested
- Biliary stent
- Medical subject headings
- Cholestasis, Extrahepatic, Pancreatic Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary stentDevice
Palliation of malignant biliary obstruction
| Study group | Role | What they receive |
|---|---|---|
| Multiple Plastic Stents | Active comparator | Patients will receive two 8.5Fr Platic biliary stents placed side by side across the biliary stricture. Receives: Device: Biliary stent |
| Self-expandable Metal Stents | Active comparator | Patients will receive a fully covered Self-expandable Metal Stents (10mm) across the biliary stricture Receives: Device: Biliary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients without stent failure
Number of patients without Stent failure (jaundice) or death with a patent stent
Measured: 12 months
Secondary outcomes (3)
Overall survival
Number of patietns alive in each group at 12 months
Measured: 12 months
Stent deployment failure
Number of patients in whom there was failure to deploy the assigned stent(s) after randomisation
Measured: During procedure
Cost
The differance in treatment costs between the two groups, measured in USD
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct Obstruction, ExtrahepaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Bernon, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821025
- Sponsor's protocol ID
- 661/2017
- Status last verified
- Feb 2019
- First submitted
- 26 Jan 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Malignant Distal Biliary Obstruction - a Randomized Study
- ClinicalTrials.gov ID
- NCT03821025
- Acronym / sponsor ID
- 661/2017
- Conditions
- Bile Duct Obstruction, Extrahepatic, Cancer of the Pancreas, Cancer of the Bile Duct, Biliary Stricture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Plastic Stents | Active comparator | Device: Biliary stentPatients will receive two 8.5Fr Platic biliary stents placed side by side across the biliary stricture. |
| Self-expandable Metal Stents | Active comparator | Device: Biliary stentPatients will receive a fully covered Self-expandable Metal Stents (10mm) across the biliary stricture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biliary stentPalliation of malignant biliary obstruction | Device | Multiple Plastic Stents, Self-expandable Metal Stents |
Primary outcome
Number of patients without stent failure
Time frame: 12 months
Number of patients without Stent failure (jaundice) or death with a patent stent
3 secondary outcomes
Overall survival
Time frame: 12 months
Stent deployment failure
Time frame: During procedure
Cost
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biliary stent in people with Bile Duct Obstruction, Extrahepatic and Cancer of the Pancreas, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc M Bernon, MBBCh (+27 (0)21 404 3042, mm.bernon@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients without stent failure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.