Direct Peritoneal Resuscitation Plus Conventional Resuscitation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatic Cancer

Intervention / Treatment
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* Drug: Galactose
* Drug: Standard Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br>Standard liver surgery and post-operative treatment | Drug: Standard Treatment<br>* Standard liver surgery.<br>|
| Experimental: Galactose<br>Standard liver surgery with direct peritoneal resuscitation with galactose after surgery. | Drug: Galactose<br>* After surgery, galactose will be dripped into the belly for up to 24 hours after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine levels |  | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver cancer