Trial document




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  DRKS00000005

Trial Description

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Title

DISPACT: Distal Pancreatectomy - A randomized controlled trial to compare two different surgical techniques

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Trial Acronym

DISPACT-Trial

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URL of the Trial

http://www.DISPACT.de

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Brief Summary in Lay Language

The aim of the trial is to evaluate, which surgical technique is the best to reduce postoperative pancreatic fistula rate. Therefore two surgical techniques are compared to each other. Both techniques share the same goal: to remove the diseased tissue, the pancreatic tail. This resection can be performed either with the scalpel or with the stapler. Using the stapler, the remaining part of the pancreas will be closed with a stapler line, while the resection with the scalpel is followed by the manual suture of the remaining part of the pancreas. Both techniques are standards, that are used in many hospital to the same extend. But until today there is no evidence of the superiority of one techniques towards the other regarding the incidence of postoperative pancreatic fistula.

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Brief Summary in Scientific Language

This is a multi-center, pre-operatively randomized, controlled and patient and observer blinded trial performed as a parallel group adaptive superiority design. The randomization is done stratified for centers and risk level (low/high). The patient is blinded for the technique used in order to prevent an impact on secondary endpoints.

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Organizational Data

  •   DRKS00000005
  •   2008/08/08
  •   2006/07/18
  •   yes
  •   Approved
  •   245/2006, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   18452029  (ISRCTN Register)
  •   UKF001249  (Register Klinischer Studien des Universitätsklinikums Freiburg)
  •   DISPACT-Trial 
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Health Condition or Problem studied

  •   C25 -  Malignant neoplasm of pancreas
  •   K86.3 -  Pseudocyst of pancreas
  •   K86.1 -  Other chronic pancreatitis
  •   5-524: null
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Interventions/Observational Groups

  •   Control group: Scalpel resectioning and manual closing of suture
  •   Experimental group: Resectioning and closing with stapler
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Characteristics

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

Combined primary endpoint: presence of a pancreatic fistula and / or death due to any cause on day 7 postoperatively.

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Secondary Outcome

Secondary endpoints: operating time, frequency of burst abdomen, wound infection, and intraabdominal fluid collection and abscess, postoperative length of hospital stay, new onset of diabetes mellitus, one-year survival.

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Countries of Recruitment

  •   Belgium
  •   Italy
  •   Netherlands
  •   Slovenia
  •   United Kingdom
  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2007/01/01
  •   450
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

-Age equal or above 18 years
-Expected survival time more than 12 month
-Patients with at least one of the following pathologic diseases scheduled for elective resection:
*Resectable malignancies of pancreatic body and/or tail
*Resectable chronic pancreatitis of the body and/or tail
*Resectable benigne tumours of the pancreas including neuroendocrine tumours
*Resectable pseudocyst of the pancreatic body and/or tail

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Exclusion Criteria

-Current immunosuppressive therapy
-Chemotherapy within 2 weeks before operation
-Radiotherapy within 8 weeks before operation
-Curative resecion is not feasible
-Severe psychiatric or neurologic diseases
-Drug- and/or alcohol-abuse according to local standarts
-Participation in another intervention trial with interference of intervention or outcome
-Inability to follow instructions given by the investigator or interviewer
-Expected lack of compliance
-Lack of informed consent

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Addresses

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    • Universitätsklinikum Heidelberg Studienzentrum der Deutschen Gesellschaft für Chirurgie (SDGC)
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universitätsklinikum Heidelberg
    • Mr.  Dr. med.  Markus  Diener 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Studienzentrum der Deutschen Gesellschaft für Chirurgie-SDGC Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universität Heidelberg
    • Ms.  Inga  Rossion 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung DLR Projektträger Gesundheitsforschung
    • Heinrich-Konen-Str. 1
    • 53227  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2009/07/03
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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.