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

This study has been completed.
Information provided by (Responsible Party):
Tampere University Hospital Identifier:
First received: October 25, 2011
Last updated: July 1, 2015
Last verified: October 2011
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 ] [ Designated as safety issue: Yes ]
    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)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

Inclusion Criteria:

  • Pancreaticoduodenectomy patients in Tampere University Hospital

Exclusion Criteria:

  • Patients with an ongoing cortisone treatment
  • Cefuroxime allergy
  • Chronic pancreatitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01460615

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

Responsible Party: Tampere University Hospital Identifier: NCT01460615     History of Changes
Other Study ID Numbers: R11009M 
Study First Received: October 25, 2011
Last Updated: July 1, 2015
Health Authority: Finland: Finnish Medicines Agency

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

Additional relevant MeSH terms:
Postoperative Complications
Digestive System Diseases
Pancreatic Diseases
Pathologic Processes
Anti-Inflammatory Agents processed this record on May 26, 2016