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Long Time Follow up After HJ Following Iatrogenic Bile Duct Injuries

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. Identifier: NCT01447030
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : October 21, 2014
Aalborg University Hospital
Aarhus University Hospital
Herlev Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Nicolaj Markus Stilling, Odense University Hospital

Brief Summary:
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 or disease
Biliary Strictur After Hepatojejunostomy (HJ). Morbidity and Mortality After and Around HJ

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Study Type : Observational
Actual Enrollment : 139 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Langtidsopfølgning Efter Kirurgisk Behandling af Iatrogene galdevejslæsioner opstået i Forbindelse Med Cholecystektomi
Study Start Date : October 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

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.

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Responsible Party: Nicolaj Markus Stilling, Doctor, Odense University Hospital Identifier: NCT01447030     History of Changes
Other Study ID Numbers: NMS1
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: October 21, 2014
Last Verified: October 2014
Keywords provided by Nicolaj Markus Stilling, Odense University Hospital:
Biliary strictur
Iatrogenic major bile duct injury