Back to resultsCortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy and Distal Pancreatic Resection
Primary Purpose
Postoperative Complications, Postoperative Pancreatitis
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Hydrocortisone
Sponsored by
About this trial
This is an interventional trial for Postoperative Complications focused on measuring Postoperative pancreatitis, Postoperative complications, Delayed gastric emptying, Leakage, Fistula, Acinar cell, Risk patient, Pancreaticoduodenectomy, Whipple, Cortisone
Eligibility Criteria
Inclusion Criteria:
- Pancreaticoduodenectomy and distal pancreatectomy patients in Tampere University Hospital
Exclusion Criteria:
- Patients with an ongoing cortisone treatment
- Cefuroxime allergy
- Chronic pancreatitis
Sites / Locations
- Tampere University Hospital
Outcomes
Primary Outcome Measures
Postoperative overall complications of pancreatic resection
e.g. Postoperative pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage, biliary fistula, wound infection, postoperative pancreatitis.
Secondary Outcome Measures
Full Information
NCT ID
NCT01460615
First Posted
October 25, 2011
Last Updated
November 27, 2018
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01460615
Brief Title
Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy and Distal Pancreatic Resection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Postoperative Pancreatitis
Keywords
Postoperative pancreatitis, Postoperative complications, Delayed gastric emptying, Leakage, Fistula, Acinar cell, Risk patient, Pancreaticoduodenectomy, Whipple, Cortisone
7. Study Design
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Primary Outcome Measure Information:
Title
Postoperative overall complications of pancreatic resection
Description
e.g. Postoperative pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage, biliary fistula, wound infection, postoperative pancreatitis.
Time Frame
within the first 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Pancreaticoduodenectomy and distal pancreatectomy patients in Tampere University Hospital
Exclusion Criteria:
Patients with an ongoing cortisone treatment
Cefuroxime allergy
Chronic pancreatitis
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
27429037
Citation
Laaninen M, Sand J, Nordback I, Vasama K, Laukkarinen J. Perioperative Hydrocortisone Reduces Major Complications After Pancreaticoduodenectomy: A Randomized Controlled Trial. Ann Surg. 2016 Nov;264(5):696-702. doi: 10.1097/SLA.0000000000001883.
Results Reference
derived
Learn more about this trial
Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy and Distal Pancreatic Resection
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