Biliary TractBiELLANCT04115696
Biodegradable Stent Implantation in Biliary Benign Strictures.
An observational study of Biliary Tract and Biliary Tract Diseases, run by Group of Research in Minimally Invasive Techniques at 2 sites in Spain.
Trial summary
Spanish registry of resorbable stent implantation in biliary benign strictures. This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract, Biliary Tract Diseases, Stenosis
- What is being tested?
- Percutaneous placement of biodegradable biliary stents
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Mar 2012to 4 Jul 2019
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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
Study population: 120- 150 patients
Who may be able to join
- Older than 18 years-old
- Informed consent
- Non-lithiasic chronic bening single or multiple stenosis
- Possibility of follow-up plus 1 year
Who cannot join
- Under 18 years old
- Unsigned consent
- Non treatable coagulopathy
- Acute signs of infection
- Diagnosis of neoplasia
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Parc Tauli
Sabadell, Barcelona, 08208
Lozano Blesa Universitary Hospital
Zaragoza, Aragon, 50009
About this study
Official title: Biodegradable Stent Implantation in Biliary Benign Strictures. Spanish Register.
Spanish registry of resorbable stent implantation in biliary benign strictures.
This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain).
A software tool hosted on the official website of SERVEI and the journal Intervencionismo will be used for data collection a(https://estudios.watsoncme.com).
Read the detailed description
This is an prospective observational study of patients that have been implanted a biodegradable stent in the biliary tree.
Patients are recruited when the stent is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24, 36, 48 and 52 months.
- Conditions
- Biliary Tract, Biliary Tract Diseases, Stenosis, Follow-Up Studies, Stents
- Being tested
- Percutaneous placement of biodegradable biliary stents
- Medical subject headings
- Biliary Tract Diseases, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous placement of biodegradable biliary stentsDevice
The bening biliary strictures stents used in this register are made of polydioxanone (PPDX) (Ella-DV biliary stent, ELLACS, Hradec Králové, Czech Republic). The stents are implanted using a percutaneous transhepatic cholangiography using the standard micropuncture technique. Before stent implantation, balloon bilioplasty may be performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Biliary duct patency: bilirubin alterations (> 2.2)
Biliary duct patency after stent implantation evaluating bilirubin alterations
Measured: 24 months
Stent reabsorption: radiographic persistence of stent radiopaque marks
Radiography
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 posted4 Oct 2019
- Study start1 Mar 2012
- Primary completion3 Feb 2018
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary TractStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Group of Research in Minimally Invasive Techniques
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115696
- Sponsor's protocol ID
- GITMI-03
- Acronym
- BiELLA
- Status last verified
- Oct 2019
- First submitted
- 12 Sep 2018
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodegradable Stent Implantation in Biliary Benign Strictures. Spanish Register.
- ClinicalTrials.gov ID
- NCT04115696
- Acronym / sponsor ID
- BiELLA / GITMI-03
- Conditions
- Biliary Tract, Biliary Tract Diseases, Stenosis, Follow-Up Studies, Stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Group of Research in Minimally Invasive TechniquesUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 3 Feb 2018 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 4 Oct 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.
Spanish registry of resorbable stent implantation in biliary benign strictures.
This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain).
A software tool hosted on the official website of SERVEI and the journal Intervencionismo will be used for data collection a(https://estudios.watsoncme.com).
Detailed description
This is an prospective observational study of patients that have been implanted a biodegradable stent in the biliary tree.
Patients are recruited when the stent is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24, 36, 48 and 52 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120- 150 patients
Key inclusion criteria (4 listed)
- Older than 18 years-old
- Informed consent
- Non-lithiasic chronic bening single or multiple stenosis
- Possibility of follow-up plus 1 year
Key exclusion criteria (5 listed)
- Under 18 years old
- Unsigned consent
- Non treatable coagulopathy
- Acute signs of infection
- Diagnosis of neoplasia
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 |
|---|---|---|
| Percutaneous placement of biodegradable biliary stentsThe bening biliary strictures stents used in this register are made of polydioxanone (PPDX) (Ella-DV biliary stent, ELLACS, Hradec Králové, Czech Republic). The stents are implanted using a percutaneous transhepatic cholangiography using the standard micropuncture technique. Before stent implantation, balloon bilioplasty may be performed. | Device | – |
Primary outcome
Biliary duct patency: bilirubin alterations (> 2.2)
Time frame: 24 months
Biliary duct patency after stent implantation evaluating bilirubin alterations
Stent reabsorption: radiographic persistence of stent radiopaque marks
Time frame: 12 months
Radiography
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 9 Oct 2019.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract and Biliary Tract Diseases, run by Group of Research in Minimally Invasive Techniques at 2 sites in Spain.
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 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Biliary duct patency: bilirubin alterations (> 2.2) (time frame: 24 months). The study lists 2 primary outcomes in all. 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 9 Oct 2019.