Malignant Biliary ObstructionBIGDIAMNCT04405752
Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study
An observational study of Malignant Biliary Obstruction, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Biliary stent allows the drainage of the bile ducts palliatively or preoperatively in the event of malignant biliary stenosis, and a biliary calibration in the event of benign stenosis. Currently, by expert agreement, the diameter is 10-mm for metal stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Biliary Obstruction
- What is being tested?
- 12-mm metallic biliary stent and 10-mm metallic biliary stent
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2017to 1 Apr 2018
- 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: From April 2017 to April 2018, at the Paoli Calmettes Institute, 24 patients with benign or malignant biliary strictures were treated by placing a metallic biliary stent, covered or uncovered, KEBOMED HILZO 12mm in diameter (length 4 or 6 cm). "Control" patients, who had benefited from the placement of a biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm) were searched on a database (ConsortConsore®️)extending from January 2016 to March 2018. "Cases" patients were exactly matched in a ratio 1:2 to "control" on the following criteria: age (per decade), sex, pathology responsible for biliary stenosis (i.e., benign or malignant stenosis) and type of stent (i.e., covered/uncovered). When we searched for control patients in our database, the first patient with matching criteria was included.
Who may be able to join
- benign and malignant biliary stricture of the lower or median portion of the main biliary duct with indication of biliary stent placement including pre-operatively drainage
- age≥ 18 years old;
- Karnofsky score ≥ 40.
Who cannot join
- hilar stenosis;
- coagulation disorder (PT <50%, platelets < 80,000).
Trial locations and contacts
1 site in 1 country.
About this study
Biliary stent allows the drainage of the bile ducts palliatively or preoperatively in the event of malignant biliary stenosis, and a biliary calibration in the event of benign stenosis. Currently, by expert agreement, the diameter is 10-mm for metal stent. Since 2017, larger stents have been marketed in France and are approved for the biliary drainage of benign and malignant biliary stricture. These new 12-mm diameter stent could reduce the risk of recurrent biliary obstruction (RBO) and therefore increase the stent duration. The aim of our study was to compare whether the permeability of 12-mm diameter stent was better than a conventional 10-mm, covered or uncovered prosthesis depending on the indication.
- Conditions
- Malignant Biliary Obstruction
- Being tested
- 12-mm metallic biliary stent, 10-mm metallic biliary stent
- Keywords
- biliary stent, malignant biliary stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-mm metallic biliary stentDevice
Metallic biliary stent, covered or uncovered,KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).
10-mm metallic biliary stentDevice
Biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm)
| Study group | Role | What they receive |
|---|---|---|
| 12-mm diameter metallic billiary stent | Not described Receives: Device: 12-mm metallic biliary stent | |
| 10-mm diameter metallic billiary stent | Not described Receives: Device: 10-mm metallic biliary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrent biliary obstruction (RBO)
RBO is defined as the time from the prosthesis deployment to until the first biliary stent obstruction (patency
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 posted28 May 2020
- Study start1 Apr 2017
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice Caillol, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405752
- Sponsor's protocol ID
- BIGDIAM-IPC 2018-056
- Acronym
- BIGDIAM
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 28 May 2020
- 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 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study
- ClinicalTrials.gov ID
- NCT04405752
- Acronym / sponsor ID
- BIGDIAM / BIGDIAM-IPC 2018-056
- Conditions
- Malignant Biliary Obstruction
- Keywords
- biliary stent, malignant biliary stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 28 May 2020 (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.
Biliary stent allows the drainage of the bile ducts palliatively or preoperatively in the event of malignant biliary stenosis, and a biliary calibration in the event of benign stenosis. Currently, by expert agreement, the diameter is 10-mm for metal stent. Since 2017, larger stents have been marketed in France and are approved for the biliary drainage of benign and malignant biliary stricture. These new 12-mm diameter stent could reduce the risk of recurrent biliary obstruction (RBO) and therefore increase the stent duration. The aim of our study was to compare whether the permeability of 12-mm diameter stent was better than a conventional 10-mm, covered or uncovered prosthesis depending on the indication.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-mm diameter metallic billiary stent | – | Device: 12-mm metallic biliary stent |
| 10-mm diameter metallic billiary stent | – | Device: 10-mm metallic biliary stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From April 2017 to April 2018, at the Paoli Calmettes Institute, 24 patients with benign or malignant biliary strictures were treated by placing a metallic biliary stent, covered or uncovered, KEBOMED HILZO 12mm in diameter (length 4 or 6 cm). "Control" patients, who had benefited from the placement of a biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm) were searched on a database (ConsortConsore®️)extending from January 2016 to March 2018. "Cases" patients were exactly matched in a ratio 1:2 to "control" on the following criteria: age (per decade), sex, pathology responsible for biliary stenosis (i.e., benign or malignant stenosis) and type of stent (i.e., covered/uncovered). When we searched for control patients in our database, the first patient with matching criteria was included.
Key inclusion criteria (3 listed)
- benign and malignant biliary stricture of the lower or median portion of the main biliary duct with indication of biliary stent placement including pre-operatively drainage
- age≥ 18 years old;
- Karnofsky score ≥ 40.
Key exclusion criteria (2 listed)
- hilar stenosis;
- coagulation disorder (PT <50%, platelets < 80,000).
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 |
|---|---|---|
| 12-mm metallic biliary stentMetallic biliary stent, covered or uncovered,KEBOMED HILZO 12mm in diameter (length 4 or 6 cm). | Device | 12-mm diameter metallic billiary stent |
| 10-mm metallic biliary stentBiliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm) | Device | 10-mm diameter metallic billiary stent |
Primary outcome
Time to recurrent biliary obstruction (RBO)
Time frame: 12 months
RBO is defined as the time from the prosthesis deployment to until the first biliary stent obstruction (patency
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 28 May 2020.
- 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.
Fabrice Caillol principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Biliary Obstruction, run by Institut Paoli-Calmettes at 1 site in France.
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 2 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 28 May 2020. 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 France. 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?
Time to recurrent biliary obstruction (RBO) (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 28 May 2020.