Malignant Biliary StricturesNCT01457105
Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent
A study testing Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent) in people with Malignant Biliary Strictures, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
self-expandable metal stents for palliation of malignant biliary strictures Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Biliary Strictures
- What is being tested?
- Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2006to Jun 2009
- 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
- Patients with malignant stenosis at the middle or lower third of the common bile duct inoperable and/or unresectable.
- Patients without liver metastases and 6 months life expectancy
- Patients at the first attempt of endoscopic biliary drainage.
- Negative history for biliary tract surgery.
Who cannot join
- Patients with ampullary cancer.
- Patients with hilar and/or intra-hepatic ducts malignancy.
- Patients with haemobilia.
- Patients with acute cholangitis at the time of stenting.
- Patients with previous percutaneous, endoscopic or surgical biliary drainage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PARTIALLY COVERED NITINOL "ComVi" STENT FOR PALLIATION OF MALIGNANT NON HILAR BILIARY OBSTRUCTION
self-expandable metal stents for palliation of malignant biliary strictures
Read the detailed description
The ComVi biliary stent (Taewoong Medical Inc., Seoul, Korea), is a covered metallic stent with a expanded polytetrafluoroethylene (e-PTFE) membrane sandwiched between two wire layers and has a weaker axial force than other stents.
Patients with middle-distal malignant biliary stricture and with symptoms as jaundice, itching and pain.
- Conditions
- Malignant Biliary Strictures
- Being tested
- Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)
- Keywords
- Malignant strictures of the main biliary duct
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)Device
Metal stents placement in the main biliary duct during ERC
| Study group | Role | What they receive |
|---|---|---|
| ComVi biliary stent | Experimental | Not described Receives: Device: Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
patency and effectiveness of the ComVi stent in palliation of jaundice in patients with malignant biliary strictures
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startNov 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Biliary StricturesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Guido Costamagna, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457105
- Sponsor's protocol ID
- A/1531/05
- Status last verified
- Oct 2011
- First submitted
- 19 Oct 2011
- Last updated
- 21 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARTIALLY COVERED NITINOL "ComVi" STENT FOR PALLIATION OF MALIGNANT NON HILAR BILIARY OBSTRUCTION
- ClinicalTrials.gov ID
- NCT01457105
- Acronym / sponsor ID
- A/1531/05
- Conditions
- Malignant Biliary Strictures
- Keywords
- Malignant strictures of the main biliary duct
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Oct 2011 (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.
self-expandable metal stents for palliation of malignant biliary strictures
Detailed description
The ComVi biliary stent (Taewoong Medical Inc., Seoul, Korea), is a covered metallic stent with a expanded polytetrafluoroethylene (e-PTFE) membrane sandwiched between two wire layers and has a weaker axial force than other stents.
Patients with middle-distal malignant biliary stricture and with symptoms as jaundice, itching and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ComVi biliary stent | Experimental | Device: Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with malignant stenosis at the middle or lower third of the common bile duct inoperable and/or unresectable.
- Patients without liver metastases and 6 months life expectancy
- Patients at the first attempt of endoscopic biliary drainage.
- Negative history for biliary tract surgery.
Key exclusion criteria (5 listed)
- Patients with ampullary cancer.
- Patients with hilar and/or intra-hepatic ducts malignancy.
- Patients with haemobilia.
- Patients with acute cholangitis at the time of stenting.
- Patients with previous percutaneous, endoscopic or surgical biliary drainage.
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 |
|---|---|---|
| Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)Metal stents placement in the main biliary duct during ERC | Device | ComVi biliary stent |
Primary outcome
patency and effectiveness of the ComVi stent in palliation of jaundice in patients with malignant biliary strictures
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent) in people with Malignant Biliary Strictures, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 21 Oct 2011. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patency and effectiveness of the ComVi stent in palliation of jaundice in patients with malignant biliary strictures (time frame: two years). 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 21 Oct 2011.