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Biliary Hilar Drainage Managed by Endoscopy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02876523
Acronym
HILARIUM
Enrollment
50
Registered
2016-08-23
Start date
2015-02-28
Completion date
2017-12-31
Last updated
2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hilar Biliary Strictures

Brief 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. 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.

Interventions

None listed

Sponsors

Institut Paoli-Calmettes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>18 years * Biliary strictures requiring a drainage

Exclusion criteria

* Contraindication to hilar biliary drainage

Design outcomes

Primary

MeasureTime frameDescription
Efficacy evaluated by the need for re-interventionsup to 2 yearsNumber of re-interventions
Efficacy evaluated by the need for re-hospitalizationup to 2 yearsNumber of re-hospitalization
Efficacy evaluated by complete or partial liver drainageup to 2 yearsrealization of complete or partial liver drainage

Secondary

MeasureTime frameDescription
Toxicity: Occurrence of drainage complications (sepsis, hemorrhage)up to 2 yearsOccurrence of drainage complications (sepsis, hemorrhage)

Countries

France

Contacts

Primary ContactDominique Genre, MD
drci.up@ipc.unicancer.fr0033491223778

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026