A Comparison of Direct Peritoneal Resuscitation Plus Conventional Resuscitation Versus Conventional Resuscitation Alone in Patients Undergoing Hepatic Resection for Cancer
Our study will focus on 108 patients requiring hepatic resection for colorectal cancer
metastasis or primary hepatocellular carcinoma. These patients will then be randomized into
two 54 patient arms: the control arm of conventional resuscitation only and the experimental
arm of conventional resuscitation with DPR immediately post operatively. Patient exclusion
criteria will be: 1) unable to obtain proper consent for enrollment, 2) age less than 18
years or greater than 75 years, 3) chronic renal failure, cirrhosis, or congestive heart
failure, 4) patients requiring portal venous embolization prior to resection, or 5) women
who are pregnant or lactating/breast feeding. A pregnancy test (urine or blood) will be
done for female subjects of child bearing potential the day prior or the morning of surgery
per the usual standard of care pre-op labs.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Morbidity
Six months
No
Jason Smith, MD
Principal Investigator
U Louisville
United States: Institutional Review Board
12.0262
NCT01882218
September 2012
March 2015
Name | Location |
---|---|
University of Louisville Hospital | Louisville, Kentucky 40202 |
Norton Hospital | Louisville, Kentucky 40202 |