Trial document




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  DRKS00000767

Trial Description

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Title

Pancreatogastrostomy versus pancreatojejunostomy for RECOnstruction after partial PANCreatoduodenectomy – A randomized controlled trial

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Trial Acronym

RECOPANC

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URL of the Trial

http://www.recopanc-studie.de

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Brief Summary in Lay Language

Comparison of two different surgical approaches for reconstruction of the pancreas to the gastrointestinaltract after excision of the pancreatic head due to chronic panreatitis or tumor, regarding the incidence of pancreatic fistula. Patients scheduled for elective partial pancreatoduodenectomy and
age ≥ 18 years are allowed to participate into this trial.


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Brief Summary in Scientific Language

A randomized controlled trial to compare pancreatogastrostomy versus pancreatojejunostomy for reconstruction after partial pancreatoduodenectomy regarding the incidence of pancreatic fistula (Grade B or C) and other complications.
Amendment: Ethic committee approval 27/7/2012 due to increased number of recruited patients

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Organizational Data

  •   DRKS00000767
  •   2011/03/23
  •   [---]*
  •   yes
  •   Approved
  •   365/10, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1117-9588 
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Health Condition or Problem studied

  •   C25.0 -  Malignant neoplasm: Head of pancreas
  •   K86.1 -  Other chronic pancreatitis
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Interventions/Observational Groups

  •   Pancreatojejunostomy
  •   Pancreatogastrostomy
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

postoperative pancreatic fistula (Grade B or C)defined according to International Study Group of Pancreatic Surgery, ISGPS within 30 days after reconstruction

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Secondary Outcome

delayed gastric emptying of grade B or C (ISGPS definition) during hospital stay
- postpancreatectomy hemorrhage (ISGPS definition)
- postoperative pancreatic fistula of grade A (ISGPS definition)30 days post-OP
- postoperative hospital stay
- operation time
- parameters of endocrine and exocrine pancreatic function and Quality of Life
(EORTC QLQ-C30 and PAN 26 subscores) 30 days, 6 and 12 months after the
operation
- in-hospital mortality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/06/01
  •   438
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

-Patients scheduled for elective partial pancreaticoduodenectomy
-Age ≥ 18 years
-Written informed consent

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Exclusion Criteria

Participation in another intervention-trial with interference of intervention and outcome of this study
Expected lack of compliance

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinikum Schleswig Holstein Campus Lübeck
    • Mr.  Prof. Dr. med.   Tobias  Keck 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Uniklinikum Schleswig-Holstein Campus Lübeck
    • Mr.  Dr.  Ulrich   Wellner 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Studienzentrum der Deutschen Gesellschaft für Chirurgie Chirurgische Universitätsklink Heidelberg
    • Ms.  Inga  Wegener 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/05
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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.