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

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. Identifier: NCT01460615
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : July 2, 2015
Information provided by (Responsible Party):
Tampere University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Postoperative Complications Postoperative Pancreatitis Drug: Hydrocortisone Phase 2

Study Type : Interventional  (Clinical Trial)
Study Start Date : February 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Pancreaticoduodenectomy patients in Tampere University Hospital

Exclusion Criteria:

  • Patients with an ongoing cortisone treatment
  • Cefuroxime allergy
  • Chronic pancreatitis

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 identifier (NCT number): NCT01460615

Tampere University Hospital
Tampere, Finland, 33520
Sponsors and Collaborators
Tampere University Hospital

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

Keywords provided by Tampere University Hospital:
Postoperative pancreatitis
Postoperative complications
Delayed gastric emptying
Acinar cell
Risk patient

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