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Long Time Follow up After HJ Following Iatrogenic Bile Duct Injuries

This study has been completed.
Sponsor:
Collaborators:
Aalborg Universitetshospital
Aarhus University Hospital
Herlev Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Nicolaj Markus Stilling, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01447030
First received: October 2, 2011
Last updated: October 19, 2014
Last verified: October 2014
  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 Odense University Hospital:

Primary Outcome Measures:
  • Stricture of HJ [ Time Frame: days to years ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Nicolaj Markus Stilling, Doctor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01447030     History of Changes
Other Study ID Numbers: NMS1
Study First Received: October 2, 2011
Last Updated: October 19, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:
Biliary strictur
Hepatojejunostomy
Iatrogenic major bile duct injury

ClinicalTrials.gov processed this record on November 25, 2014