Direct Peritoneal Resuscitation Plus Conventional Resuscitation
Primary Purpose
Hepatic Cancer
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Galactose
Standard Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Cancer focused on measuring Liver cancer
Eligibility Criteria
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
Sites / Locations
- Norton Hospital
- University of Louisville Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard treatment
Galactose
Arm Description
Standard liver surgery and post-operative treatment
Standard liver surgery with direct peritoneal resuscitation with galactose after surgery.
Outcomes
Primary Outcome Measures
Morbidity
Secondary Outcome Measures
Cytokine levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01882218
Brief Title
Direct Peritoneal Resuscitation Plus Conventional Resuscitation
Official Title
A Comparison of Direct Peritoneal Resuscitation Plus Conventional Resuscitation Versus Conventional Resuscitation Alone in Patients Undergoing Hepatic Resection for Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Not feasable at this site
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Cancer
Keywords
Liver cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Standard liver surgery and post-operative treatment
Arm Title
Galactose
Arm Type
Experimental
Arm Description
Standard liver surgery with direct peritoneal resuscitation with galactose after surgery.
Intervention Type
Drug
Intervention Name(s)
Galactose
Intervention Description
After surgery, galactose will be dripped into the belly for up to 24 hours after surgery
Intervention Type
Drug
Intervention Name(s)
Standard Treatment
Intervention Description
Standard liver surgery.
Primary Outcome Measure Information:
Title
Morbidity
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Cytokine levels
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Smith, MD
Organizational Affiliation
U Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norton Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Direct Peritoneal Resuscitation Plus Conventional Resuscitation
We'll reach out to this number within 24 hrs