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

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).

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Key information

Conditions

Postoperative Complications Digestive System Diseases Fistula Gastrointestinal Diseases Gastroparesis Neurologic Manifestations Paralysis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Pancreatitis Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tampere University Hospital

Tampere, 33520, Finland

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pancreaticoduodenectomy and distal pancreatectomy patients in Tampere University Hospital

Exclusion criteria

Patients with an ongoing cortisone treatment
Cefuroxime allergy
Chronic pancreatitis

Treatment and study plan

Hydrocortisone

Drug

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.

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2017
Study completion: 2017
First posted: Oct 27, 2011
Registry last updated: Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed