Biliary Tract CancerNCT02102984
Covered Versus Uncovered Biliary Stents for Biliary Malignancies
A study testing covered biliary stents and uncovered biliary stents in people with Biliary Tract Cancer, run by Nuovo Ospedale Civile S.Agostino Estense at 1 site in Italy.
Trial summary
Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- covered biliary stents and uncovered biliary stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2014to Dec 2015
- 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
- adult patients with symptomatic malignant obstruction of the extra-hepatic biliary tree
- not eligible for surgical intervention
- able to provide informed consent
Who cannot join
- benign biliary obstruction
- previous surgery of the biliary tract
- life expectancy < 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Covered Versus Uncovered Metal Stents for Biliary Malignancies - A Randomized Controlled Trial
Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree.
Read the detailed description
Consecutive patients with malignant strictures of the extra-hepatic biliary tree considered unfit for surgical excision Placement of covered or uncovered metal stents in patients with and without gallbladder on the basis of a computer-generated randomization list Evaluation of clinical outcome, survival, complications, and quality of life. Evaluation of the cost and efficacy of the two types of metal stents.
- Conditions
- Biliary Tract Cancer
- Being tested
- covered biliary stents, uncovered biliary stents
- Keywords
- distal malignancy of the extra-hepatic biliary tract, metallic biliary stents, covered biliary stents, uncovered biliary stents
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covered biliary stentsDevice
Also called Taewoong Medical NITI-S Covered
endoscopic placement of covered biliary stents
uncovered biliary stentsDevice
Also called Taewoong Medical NITI-S Uncovered
endoscopic placement of uncovered biliary stents
| Study group | Role | What they receive |
|---|---|---|
| covered stents | Active comparator | endoscopic placement of covered biliary stents Receives: Device: covered biliary stents |
| uncovered biliary stents | Active comparator | endoscopic placement of uncovered biliary stents Receives: Device: uncovered biliary stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of malignant biliary obstruction
Clinical assessment
Measured: six months
Secondary outcomes (1)
cost/effecacy
cost and effectiveness of covered versus uncovered biliary stents
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 posted3 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract CancerStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuovo Ospedale Civile S.Agostino Estense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Conigliaro, MD, Nuovo Ospedale Civile S.Agostino Estense
- Investigators
- Rita Conigliaro, MD, Principal investigator, Digestive Endoscopy Unit-NOCSAE- Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102984
- Sponsor's protocol ID
- 242/13
- Status last verified
- Mar 2016
- First submitted
- 26 Mar 2014
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Isayama H, Nakai Y, Kogure H, Yamamoto N, Koike K. Biliary self-expandable metallic stent for unresectable malignant distal biliary obstruction: which is better: covered or uncovered? Dig Endosc. 2013 May;25 Suppl 2:71-4. doi: 10.1111/den.12078.
PubMed 23617653Conio M, Mangiavillano B, Caruso A, Filiberti RA, Baron TH, De Luca L, Signorelli S, Crespi M, Marini M, Ravelli P, Conigliaro R, De Ceglie A. Covered versus uncovered self-expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study. Gastrointest Endosc. 2018 Aug;88(2):283-291.e3. doi: 10.1016/j.gie.2018.03.029. Epub 2018 Apr 11.
PubMed 29653120
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covered Versus Uncovered Metal Stents for Biliary Malignancies - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02102984
- Acronym / sponsor ID
- 242/13
- Conditions
- Biliary Tract Cancer
- Keywords
- distal malignancy of the extra-hepatic biliary tract, metallic biliary stents, covered biliary stents, uncovered biliary stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Nuovo Ospedale Civile S.Agostino EstenseUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Apr 2014 (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.
Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree.
Detailed description
Consecutive patients with malignant strictures of the extra-hepatic biliary tree considered unfit for surgical excision Placement of covered or uncovered metal stents in patients with and without gallbladder on the basis of a computer-generated randomization list Evaluation of clinical outcome, survival, complications, and quality of life. Evaluation of the cost and efficacy of the two types of metal stents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| covered stents | Active comparator | Device: covered biliary stentsendoscopic placement of covered biliary stents |
| uncovered biliary stents | Active comparator | Device: uncovered biliary stentsendoscopic placement of uncovered biliary stents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients with symptomatic malignant obstruction of the extra-hepatic biliary tree
- not eligible for surgical intervention
- able to provide informed consent
Key exclusion criteria (3 listed)
- benign biliary obstruction
- previous surgery of the biliary tract
- life expectancy < 3 months
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 |
|---|---|---|
| covered biliary stentsAlso: Taewoong Medical NITI-S Coveredendoscopic placement of covered biliary stents | Device | covered stents |
| uncovered biliary stentsAlso: Taewoong Medical NITI-S Uncoveredendoscopic placement of uncovered biliary stents | Device | uncovered biliary stents |
Primary outcome
Relief of malignant biliary obstruction
Time frame: six months
Clinical assessment
1 secondary outcome
cost/effecacy
Time frame: 6 months
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 30 Mar 2016.
- Background: PubMed 23617653Isayama H, Nakai Y, Kogure H, Yamamoto N, Koike K. Biliary self-expandable metallic stent for unresectable malignant distal biliary obstruction: which is better: covered or uncovered? Dig Endosc. 2013 May;25 Suppl 2:71-4. doi: 10.1111/den.12078.
- Derived from this study: PubMed 29653120Conio M, Mangiavillano B, Caruso A, Filiberti RA, Baron TH, De Luca L, Signorelli S, Crespi M, Marini M, Ravelli P, Conigliaro R, De Ceglie A. Covered versus uncovered self-expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study. Gastrointest Endosc. 2018 Aug;88(2):283-291.e3. doi: 10.1016/j.gie.2018.03.029. Epub 2018 Apr 11.
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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.
Rita Conigliaro, MD principal investigator
Digestive Endoscopy Unit-NOCSAE- Modena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing covered biliary stents and uncovered biliary stents in people with Biliary Tract Cancer, run by Nuovo Ospedale Civile S.Agostino Estense 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 3 inclusion and 3 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 30 Mar 2016. 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?
Relief of malignant biliary obstruction (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02102984, which also lists 2 linked publications.
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 30 Mar 2016; AzTrials last refreshed its copy on 31 Oct 2026.