Direct Peritoneal Resuscitation Plus Conventional Resuscitation

Phase 4

Withdrawn

• Conditions: Hepatic Cancer
• Interventions: Drug: Standard Treatment; Drug: Galactose

• Registration Number: NCT01882218
• Lead Sponsor: University of Louisville

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-20
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment	Standard Treatment	Standard liver surgery and post-operative treatment
Galactose	Galactose	Standard liver surgery with direct peritoneal resuscitation with galactose after surgery.

Primary Outcome Measures

Name	Time	Method
Morbidity	Six months

Secondary Outcome Measures

Name	Time	Method
Cytokine levels	Six months

Trial Locations

Locations (2)

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States

Norton Hospital; 🇺🇸 Louisville, Kentucky, United States