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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01460615
First received: October 25, 2011
Last updated: March 19, 2013
Last verified: October 2011
History of Changes
  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:

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

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
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Pancreaticoduodenectomy patients in Tampere University Hospital

Exclusion Criteria:

  • Patients with an ongoing cortisone treatment
  • Cefuroxime allergy
  • Chronic pancreatitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460615

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

No publications provided

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01460615     History of Changes
Other Study ID Numbers: R11009M
Study First Received: October 25, 2011
Last Updated: March 19, 2013
Health Authority: Finland: Finnish Medicines Agency

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
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
 Cortisone
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013