Trial document




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  DRKS00000167

Trial Description

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Title

ChroPac-Trial
Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head. A randomized controlled multicentre trial

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Trial Acronym

ChroPac

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URL of the Trial

http://www.chropac-trial.eu/.

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Brief Summary in Lay Language

There are two different surgical techniques for removing the head of the pancreas: The duodenum-preserving head resection (resection of the head of the pancreas only) and the pancreatico-duodenectomy (resection of the head of the pancreas including the resection of the duodenum). . Purpose of the ChroPac study is to find out, if these two strategies may lead to equal or different quality of life from the patient's point of view.

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Brief Summary in Scientific Language

A randomised controlled multicentre trial to compare duodenum-preserving head resection to pancreaticoduodenectomy for chronic pancreatitis of the head with regard to quality of life during 24 months after surgery measured 6,12 and 24 months after surgery.The two-sided null-hypothesis states that both surgical interventions lead to the same average quality of life.

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Organizational Data

  •   DRKS00000167
  •   2009/07/29
  •   2009/04/30
  •   yes
  •   Approved
  •   S-029/2009, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   38973832  (ISRCTN)
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Health Condition or Problem studied

  •   chronic pancreatitis
  •   K86.0 -  Alcohol-induced chronic pancreatitis
  •   K86.1 -  Other chronic pancreatitis
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Interventions/Observational Groups

  •   1: Pankreaticoduodenectomy a:classical Whipple or b:pylorus-preserving Whipple
  •   2: Duodenum-preserving pancreatic head resection
    a:local resection of the pancreatic head combined with lateral pancreaticojejunostomie or
    b:subtotal resection of the pancreatic head leaving a narrow layer of pancreatic tissue towards the duodenum and the retropancreatic vessels
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Average Quality of life during 24 months after surgery, measured 6,12 and 24 months after surgery by the EORTC QLQ-C30 scale "physical functioning".

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Secondary Outcome

Mortality/Morbidity/EORTC QLQ-C30 and PAN 26 (CP) subscores/initial postoperative hospital stay after randomization/total hospital stay due to chronic pancreatitis within 24 months after randomization/Reoperation due to recurrence of chronic pancreatitis/Weight gain/New onset of diabetes mellitus requiring treatment/Development of exocrine insufficiency/operation time/Blood loss assessed by surgeons and anesthesists

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Countries of Recruitment

  •   Germany
  •   United Kingdom
  •   Slovenia
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/06/10
  •   250
  •   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

-patients with chronic pancreatitis of the head and pain eligible for elective surgical resection
-ability of subject to understand character and individual consequences of the clinical trial
- written informed consent

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Exclusion Criteria

participation in another intervention-trial with interference of intervention and outcome of this study

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Addresses

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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Studienzentrum der Deutschen Gesellschaft für Chirurgie 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral-und Transplantationschirurgie
    • Mr.  PD Dr. med.  Markus K.  Diener 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Ms.  Colette  Dörr-Harim 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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

  •   Recruiting complete, follow-up continuing
  •   [---]*
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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.