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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
  Purpose
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).

Condition Intervention Phase
Postoperative Complications Postoperative Pancreatitis Drug: Hydrocortisone Phase 2

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • 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.


Study Start Date: February 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Pancreaticoduodenectomy patients in Tampere University Hospital

Exclusion Criteria:

  • Patients with an ongoing cortisone treatment
  • Cefuroxime allergy
  • Chronic pancreatitis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460615


Locations
Finland
Tampere University Hospital
Tampere, Finland, 33520
Sponsors and Collaborators
Tampere University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01460615     History of Changes
Other Study ID Numbers: R11009M
First Submitted: October 25, 2011
First Posted: October 27, 2011
Last Update Posted: July 2, 2015
Last Verified: October 2011

Keywords provided by Tampere University Hospital:
Postoperative pancreatitis
Postoperative complications
Delayed gastric emptying
Leakage
Fistula
Acinar cell
Risk patient
Pancreaticoduodenectomy
Whipple
Cortisone

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases
Pancreatitis
Postoperative Complications
Pathologic Processes
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Cortisone
Anti-Inflammatory Agents


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