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Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy (Whipple Operation)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01460615
First Posted: October 27, 2011
Last Update Posted: July 2, 2015
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.
Information provided by (Responsible Party):
Tampere University Hospital
October 25, 2011
October 27, 2011
July 2, 2015
February 2011
June 2015   (Final data collection date for primary outcome measure)
Postoperative overall complications of pancreaticoduodenectomy [ Time Frame: within the first 30 days after surgery ]
e.g. Postoperative pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage, biliary fistula, wound infection, postoperative pancreatitis.
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Complete list of historical versions of study NCT01460615 on ClinicalTrials.gov Archive Site
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Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy (Whipple Operation)
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The purpose of this randomized, placebo-controlled trial is to investigate whether postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy (Whipple) operation may be reduced with cortisone treatment. Treatment is administered to high risk patients (defined by high amount of acinar cells in the cut edge of pancreas).
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Interventional
Phase 2
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  • Postoperative Complications
  • Postoperative Pancreatitis
Drug: Hydrocortisone
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Laaninen M, Sand J, Nordback I, Vasama K, Laukkarinen J. Perioperative Hydrocortisone Reduces Major Complications After Pancreaticoduodenectomy: A Randomized Controlled Trial. Ann Surg. 2016 Nov;264(5):696-702.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2015
June 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pancreaticoduodenectomy patients in Tampere University Hospital

Exclusion Criteria:

  • Patients with an ongoing cortisone treatment
  • Cefuroxime allergy
  • Chronic pancreatitis
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01460615
R11009M
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Tampere University Hospital
Tampere University Hospital
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Tampere University Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP