Trial document




drksid header

  DRKS00000419

Trial Description

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Title

Prospective randomized study for the comparision of two different reconstructive regarding the incidence of pancreatic fistula and other complications following partial pancreaticoduodenectomy

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Comparision of two different operative methods for the reconnection of the pancreas to the gastrointestinal tract after resection of the head of pacreas because of tumor or chronic inflammation of the pancreas

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Brief Summary in Scientific Language

Prospective randomized study for the comparision of two different reconstructive surgical techniques regarding the incidence of pancreatic fistula and other complications following partial pancreaticoduodenectomy

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Organizational Data

  •   DRKS00000419
  •   2010/06/07
  •   2006/03/15
  •   yes
  •   Approved
  •   093/05, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   UKF000532  (Register Klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   C25.0 -  Malignant neoplasm: Head of pancreas
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Pancreaticojejunostomy
  •   Pancreatogastrostomy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   [---]*
  •   [---]*
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Primary Outcome

postoperative pancreatic fistula
survival at 90 days postoperatively

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Secondary Outcome

intraabdominal abscess
sepsis
kardiogenic shock
respiratory insufficiency

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2006/03/31
  •   116
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

age over 18 years
planned pancreaticoduodenectomy for tumor or chronic pancreatitis

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Exclusion Criteria

preoperative radio- or chemotherapy
therapy with coricosteroids in week before operation
other operations in week before operation (except laparoscopy)
liver cirrhosis Child B or C

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Addresses

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    • Universitätsklinikum Freiburg Abteilung Allgemein- und Viszeralchirurgie
    • Mr.  Prof. Dr.   Tobias  Keck 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abteilung Allgemein- und Viszeralchirurgie
    • Mr.  Dr.  Ulrich  Wellner 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abteilung Allgemein- und Viszeralchirurgie
    • Mr.  Dr.  Ulrich  Wellner 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinkum Freiburg Abteilung Allgemein- und Viszeralchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/06/30
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.