Biliary Hilar Drainage Managed by Endoscopy (HILARIUM)

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 Overview

• Status: Unknown
• Conditions: Hilar Biliary Strictures

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• France
  • Bouches du Rhone
    • Marseille, Bouches du Rhone, France, 13009
      • Recruiting
      • Institut Paoli Calmettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with a hilar biliary strictures requiring a drainage

Description

Inclusion Criteria:

• Age >18 years
• Biliary strictures requiring a drainage

Exclusion Criteria:

• Contraindication to hilar biliary drainage

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with a hilar biliary stricture requiring a drainage; Drainage performed by endoscopy, echo-endoscopy or percutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy evaluated by the need for re-interventions	Number of re-interventions	up to 2 years
Efficacy evaluated by the need for re-hospitalization	Number of re-hospitalization	up to 2 years
Efficacy evaluated by complete or partial liver drainage	realization of complete or partial liver drainage	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity: Occurrence of drainage complications (sepsis, hemorrhage)	Occurrence of drainage complications (sepsis, hemorrhage)	up to 2 years

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (Estimate): August 23, 2016

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: HILARIUM-IPC 2015-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO