Hilar Biliary StricturesHILARIUMNCT02876523
Biliary Hilar Drainage Managed by Endoscopy
An observational study of Hilar Biliary Strictures, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
The management of hilar biliary strictures remains difficult. These strictures are classified in 4 types (I,II,III and IV). In palliative cases, an endoscopic drainage should be performed in types I and II while a percutaneous drainage is performed in type IV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hilar Biliary Strictures
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Dec 2017
- 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: Patient with a hilar biliary strictures requiring a drainage
Who may be able to join
- Age >18 years
- Biliary strictures requiring a drainage
Who cannot join
- Contraindication to hilar biliary drainage
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille, Bouches du Rhone, 13009
Dominique GENRE, MD, 33 4 91 22 37 78, drci.up@ipc.unicancer.fr
About this study
The management of hilar biliary strictures remains difficult. These strictures are classified in 4 types (I,II,III and IV). In palliative cases, an endoscopic drainage should be performed in types I and II while a percutaneous drainage is performed in type IV. There is controversy as to whether partial or complete liver drainage should be done. Furthermore there are no standards for drainage types (metallic stents, plastic stents). Morbidity remains high and a multistage procedure can be required.
This study aims at evaluating the clinical practices in the investigators' center in order to determine the key factors that contribute to the drainage success or failure.
- Conditions
- Hilar Biliary Strictures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a hilar biliary stricture requiring a drainage | Drainage performed by endoscopy, echo-endoscopy or percutaneously |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy evaluated by the need for re-interventions
Number of re-interventions
Measured: up to 2 years
Efficacy evaluated by the need for re-hospitalization
Number of re-hospitalization
Measured: up to 2 years
Efficacy evaluated by complete or partial liver drainage
realization of complete or partial liver drainage
Measured: up to 2 years
Secondary outcomes (1)
Toxicity: Occurrence of drainage complications (sepsis, hemorrhage)
Occurrence of drainage complications (sepsis, hemorrhage)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startFeb 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hilar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876523
- Sponsor's protocol ID
- HILARIUM-IPC 2015-003
- Acronym
- HILARIUM
- Status last verified
- Jan 2017
- First submitted
- 2 Aug 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biliary Hilar Drainage Managed by Endoscopy
- ClinicalTrials.gov ID
- NCT02876523
- Acronym / sponsor ID
- HILARIUM / HILARIUM-IPC 2015-003
- Conditions
- Hilar Biliary Strictures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Aug 2016 (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.
The management of hilar biliary strictures remains difficult. These strictures are classified in 4 types (I,II,III and IV). In palliative cases, an endoscopic drainage should be performed in types I and II while a percutaneous drainage is performed in type IV. There is controversy as to whether partial or complete liver drainage should be done. Furthermore there are no standards for drainage types (metallic stents, plastic stents). Morbidity remains high and a multistage procedure can be required.
This study aims at evaluating the clinical practices in the investigators' center in order to determine the key factors that contribute to the drainage success or failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a hilar biliary stricture requiring a drainage | – | –Drainage performed by endoscopy, echo-endoscopy or percutaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a hilar biliary strictures requiring a drainage
Key inclusion criteria (2 listed)
- Age >18 years
- Biliary strictures requiring a drainage
Key exclusion criteria (1 listed)
- Contraindication to hilar 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.
Primary outcome
Efficacy evaluated by the need for re-interventions
Time frame: up to 2 years
Number of re-interventions
Efficacy evaluated by the need for re-hospitalization
Time frame: up to 2 years
Number of re-hospitalization
Efficacy evaluated by complete or partial liver drainage
Time frame: up to 2 years
realization of complete or partial liver drainage
1 secondary outcome
Toxicity: Occurrence of drainage complications (sepsis, hemorrhage)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Hilar Biliary Strictures
Not yet recruiting
Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis
Biliary Disease Tract, Biliary Stenosis
Enrolling by invitationPhase 3
Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction
Cholangiocarcinoma Non-resectable, Gall Bladder Cancer
Recruiting
ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
Malignant Hilar Stricture
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.
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 Hilar Biliary Strictures, 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 2 inclusion and 1 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 31 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique Genre, MD (0033491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy evaluated by the need for re-interventions (time frame: up to 2 years). The study lists 3 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 31 Jan 2017.