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A Comparison of Direct Peritoneal Resuscitation Plus Conventional Resuscitation Versus Conventional Resuscitation Alone in Patients Undergoing Hepatic Resection for Cancer


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Hepatic Cancer

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Trial Information

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.


Inclusion Criteria:



- Colorectal cancer

- Scheduled for liver resection

- 18 to 75

Exclusion Criteria:

- Chronic renal failure

- Cirrhosis

- Congestive heart failure

- Requiring portal venous embolization prior to resection

- Pregnant or nursing

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Morbidity

Outcome Time Frame:

Six months

Safety Issue:

No

Principal Investigator

Jason Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

U Louisville

Authority:

United States: Institutional Review Board

Study ID:

12.0262

NCT ID:

NCT01882218

Start Date:

September 2012

Completion Date:

March 2015

Related Keywords:

  • Hepatic Cancer
  • Liver cancer
  • Liver Neoplasms

Name

Location

University of Louisville HospitalLouisville, Kentucky  40202
Norton HospitalLouisville, Kentucky  40202