Biliary ObstructionPhase 4NCT00731419
Randomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant Jaundice
A Phase 4 study testing SEMS in people with Biliary Obstruction, run by University of Cape Town at 1 site in South Africa.
Trial summary
Background: When considering any malignancy with limited life expectancy, palliation and quality of life are paramount. Owing to the limited centres offering ERCP and endoscopic palliation in the South African state sector, patients often travel vast distances and spend large amounts of time away from family and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Obstruction
- What is being tested?
- SEMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jun 2007to Aug 2009
- Phase
- Phase 4
- 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
- Symptomatic jaundice secondary to malignant distal CBD stricture
- Contra-indication to resection (advanced disease/advanced age/poor surgical risk)
Who cannot join
- Hilar/proximal CBD obstruction
- ECOG performance status 3 or 4
- Duodenal obstruction
- Previous stent placement
- Inability to comply with follow-up
- Ascites and liver metastases
- Not possible to stent endoscopically
Trial locations and contacts
1 site in 1 country.
South Africa1 site, 1 recruiting
- Recruiting
Groote Schuur Hospital
Cape Town, Western Cape, 7925
John M Sahw, MBBCh, FCS, 021-404-3042, John.Shaw@uct.ac.za
John M Shaw, MBBCH,FCS
About this study
Official title: Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice
Background:
When considering any malignancy with limited life expectancy, palliation and quality of life are paramount. Owing to the limited centres offering ERCP and endoscopic palliation in the South African state sector, patients often travel vast distances and spend large amounts of time away from family and social support structures, severely impairing their quality of life. Stent occlusion with resultant readmission to an ERCP accredited centre obviously compounds this problem.
Read more
The hypothesis we propose to test is whether metal stents as a primary procedure result in better patency rates, are more cost effective and improve quality of life than plastic stents. We propose to do this by means of a randomised trial determining the best method of palliation for inoperable distal common bile duct malignancies in the South African context.
Primary end-point Assessing the cost of metal versus plastic stenting in inoperable malignant distal common bile duct strictures in patients with expected survival of 3 months or more as palliation of symptomatic obstructive jaundice. Cost to be assessed in terms of hardware, hospital stay and readmissions for stent occlusion(patency) and complications Secondary end-point Assessing quality of life using a validated scoring system(EORTC QLQ 30) in patients receiving a metal or plastic biliary stent as definitive means of palliation of malignant obstructive jaundice
Hypothesis to be tested Metal stents are superior to plastic stents in terms of patency, resulting in more cost effective palliation of inoperable malignant jaundice and better quality of life due to fewer stent occlusions/episodes of cholangitis.
- Conditions
- Biliary Obstruction
- Being tested
- SEMS
- Keywords
- biliary, obstruction, malignant, stent, palliation
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEMSDevice
Also called Boston Scientific, biliary self-expanding metal stent, olympus plastic stent
Comparing plastic and metal stents
| Study group | Role | What they receive |
|---|---|---|
| SEMS | Active comparator | Self expanding metal stent compared to plastic stent. Both recognised forms of treatment for condition Receives: Device: SEMS |
| Plastic stent | Active comparator | Not described Receives: Device: SEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall cost comparison of metal versus plastic stent in patients with limited life expectancy
Measured: 6 months
Secondary outcomes (1)
Quality of life assessment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJun 2007
- Primary completionMay 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary ObstructionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Investigators
- John M Shaw, FCS, MMed, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731419
- Sponsor's protocol ID
- 144/2007
- Status last verified
- May 2007
- First submitted
- 5 Aug 2008
- Last updated
- 11 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice
- ClinicalTrials.gov ID
- NCT00731419
- Acronym / sponsor ID
- 144/2007
- Conditions
- Biliary Obstruction
- Keywords
- biliary, obstruction, malignant, stent, palliation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 11 Aug 2008 (estimated)
- 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.
Background:
When considering any malignancy with limited life expectancy, palliation and quality of life are paramount. Owing to the limited centres offering ERCP and endoscopic palliation in the South African state sector, patients often travel vast distances and spend large amounts of time away from family and social support structures, severely impairing their quality of life. Stent occlusion with resultant readmission to an ERCP accredited centre obviously compounds this problem.
The hypothesis we propose to test is whether metal stents as a primary procedure result in better patency rates, are more cost effective and improve quality of life than plastic stents. We propose to do this by means of a randomised trial determining the best method of palliation for inoperable distal common bile duct malignancies in the South African context.
Primary end-point Assessing the cost of metal versus plastic stenting in inoperable malignant distal common bile duct strictures in patients with expected survival of 3 months or more as palliation of symptomatic obstructive jaundice. Cost to be assessed in terms of hardware, hospital stay and readmissions for stent occlusion(patency) and complications Secondary end-point Assessing quality of life using a validated scoring system(EORTC QLQ 30) in patients receiving a metal or plastic biliary stent as definitive means of palliation of malignant obstructive jaundice
Hypothesis to be tested Metal stents are superior to plastic stents in terms of patency, resulting in more cost effective palliation of inoperable malignant jaundice and better quality of life due to fewer stent occlusions/episodes of cholangitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEMS | Active comparator | Device: SEMSSelf expanding metal stent compared to plastic stent. Both recognised forms of treatment for condition |
| Plastic stent | Active comparator | Device: SEMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic jaundice secondary to malignant distal CBD stricture
- Contra-indication to resection (advanced disease/advanced age/poor surgical risk)
Key exclusion criteria (7 listed)
- Hilar/proximal CBD obstruction
- ECOG performance status 3 or 4
- Duodenal obstruction
- Previous stent placement
- Inability to comply with follow-up
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 |
|---|---|---|
| SEMSAlso: Boston Scientific, biliary self-expanding metal stent, olympus plastic stentComparing plastic and metal stents | Device | Plastic stent, SEMS |
Primary outcome
Overall cost comparison of metal versus plastic stent in patients with limited life expectancy
Time frame: 6 months
1 secondary outcome
Quality of life assessment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2008.
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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.
John M Shaw, FCS, MMed principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SEMS in people with Biliary Obstruction, 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 2 inclusion and 7 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 11 Aug 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 John M Shaw, FCS, MMed (021-404-3042, John.Shaw@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall cost comparison of metal versus plastic stent in patients with limited life expectancy (time frame: 6 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 11 Aug 2008; AzTrials last refreshed its copy on 6 Nov 2026.