NCT03030573

Brief Summary

The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

November 19, 2016

Last Update Submit

February 5, 2017

Conditions

Bile Duct Obstruction, Extrahepatic

Keywords

Bile duct injuryBile duct defectRound ligamentReconstruction

Outcome Measures

Primary Outcomes (1)

  • Safety - absence of any severe complication or mortality related to the new procedure

    Safety is defined by the absence of any severe complication (necrosis or biliary fistula) or mortality related to the new procedure.

    at 1 year

Secondary Outcomes (1)

  • Bile buct patency

    at 3 year

Study Arms (1)

Device: Round ligament and the bile duct

OTHER

The investigators describe the safety and efficacy of the reconstruction of the bile duct with the Round ligament.

Procedure: Reconstruction of the bile duct with the round ligament

Interventions

Reconstruction of the bile duct with the round ligamentPROCEDURE

In patients who had bile duct defect by injury or resection, the Round ligament will be used to reconstruct the defect. Surgical technique, the early and long term postoperative measures are detailed in the investigators protocol.

Device: Round ligament and the bile duct

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Radiological or operative diagnosis of bile duct Injury or defect
  • Can underwent surgical procedure

You may not qualify if:

  • \) The absence of the round ligament

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement HPB surgery, Beaujon Hospital

Clichy, Hauts de seine, 92110, France

RECRUITING

MeSH Terms

Conditions

Cholestasis, Extrahepatic

Condition Hierarchy (Ancestors)

CholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Safi Dokmak, MD

    HBP department, Beaujon hospital, Clichy, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Safi Dokmak, MD

CONTACT

0033140875797safi.dokmak@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 19, 2016

First Posted

January 25, 2017

Study Start

November 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2018

Last Updated

February 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)