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Clinical Trials/NCT01460615
NCT01460615
Completed
Phase 2

Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy and Distal Pancreatic Resection

Tampere University Hospital1 site in 1 countryStarted: February 2011Last updated:
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ConditionsPostoperative ComplicationsPostoperative Pancreatitis
DrugsHydrocortisone

Overview

Phase
Phase 2
Status
Completed
Locations
1
Primary Endpoint
Postoperative overall complications of pancreatic resection
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The purpose of this randomized, placebo-controlled trial is to investigate whether postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy or distal pancreatic resection 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).

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Pancreaticoduodenectomy and distal pancreatectomy patients in Tampere University Hospital

Exclusion Criteria

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

Outcomes

Primary Outcomes

Postoperative overall complications of pancreatic resection

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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