Direct Peritoneal Resuscitation Plus Conventional Resuscitation

Hepatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01882218
• Other study ID #: 12.0262
• Status: Withdrawn
• Phase: Phase 4
• First received: June 17, 2013
• Last updated: May 2, 2017
• Start date: September 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out if direct peritoneal resuscitation (DPR) (putting a sugar solution into the abdominal cavity) helps blood flow through vital organs in the body that may suffer from low blood flow due to surgery. We will also try to find out if the DPR will help patients recover faster from liver surgery. Lastly, this study will also try to find if direct peritoneal resuscitation decreases levels of signaling chemicals in the blood called 'cytokines' and a protein called high-mobility group protein 1, which is known to cause tissue damage.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Cancer
• Liver Neoplasms

Intervention

Drug:
• Galactose
After surgery, galactose will be dripped into the belly for up to 24 hours after surgery
• Standard Treatment
Standard liver surgery.

Locations

Country	Name	City	State
United States	Norton Hospital	Louisville	Kentucky
United States	University of Louisville Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity		Six months
Secondary	Cytokine levels		Six months