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Long Time Follow up After HJ Following Iatrogenic Bile Duct Injuries

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01447030
First Posted: October 5, 2011
Last Update Posted: October 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Aalborg Universitetshospital
Aarhus University Hospital
Herlev Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Nicolaj Markus Stilling, Odense University Hospital
  Purpose
Introduction: Bile duct injury (BDI) after cholecystectomy remains a serious complication with major implications for patient outcome. For most major BDIs, the recommended method of repair is a hepaticojejunostomy (HJ). We conducted a retrospective review from 5 Danish hepatobiliary centres aiming to examine the perioperative and the long-term outcome after reconstructive HJ.

Condition
Biliary Strictur After Hepatojejunostomy (HJ). Morbidity and Mortality After and Around HJ

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Langtidsopfølgning Efter Kirurgisk Behandling af Iatrogene galdevejslæsioner opstået i Forbindelse Med Cholecystektomi

Further study details as provided by Nicolaj Markus Stilling, Odense University Hospital:

Primary Outcome Measures:
  • Stricture of HJ [ Time Frame: days to years ]
    Stricture of hepaticojejunostomy after reconstruction


Enrollment: 139
Study Start Date: October 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with iatrogenic bile duct injury (BDI) after cholecystectomy reconstructed with hepatojejunostomia. Collecting data from 5 Danish tertiary hepato-biliary centres from january 1995 to may 2009.
Criteria

Inclusion Criteria:

  • All patients with iatrogenic Bile duct injury (BDI) after cholecystectomy reconstructed with hepatojejunostomy/choledochojejunostomy.

Exclusion Criteria:

  • Patients with non-cholecystectomy-related BDI or with cholecystectomy-related BDI that had been definitively managed by other techniques.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Nicolaj Markus Stilling, Doctor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01447030     History of Changes
Other Study ID Numbers: NMS1
First Submitted: October 2, 2011
First Posted: October 5, 2011
Last Update Posted: October 21, 2014
Last Verified: October 2014

Keywords provided by Nicolaj Markus Stilling, Odense University Hospital:
Biliary strictur
Hepatojejunostomy
Iatrogenic major bile duct injury