Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: November 14, 2014
Last verified: October 2011

October 25, 2011
November 14, 2014
February 2011
March 2015   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01460615 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy (Whipple Operation)
Not Provided

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).

Not Provided
Interventional
Phase 2
Not Provided
  • Postoperative Complications
  • Postoperative Pancreatitis
Drug: Hydrocortisone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
Not Provided
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pancreaticoduodenectomy patients in Tampere University Hospital

Exclusion Criteria:

  • Patients with an ongoing cortisone treatment
  • Cefuroxime allergy
  • Chronic pancreatitis
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01460615
R11009M
Not Provided
Tampere University Hospital
Tampere University Hospital
Not Provided
Not Provided
Tampere University Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP