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Direct Peritoneal Resuscitation Plus Conventional Resuscitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01882218
Recruitment Status : Withdrawn (Not feasable at this site)
First Posted : June 20, 2013
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jason Smith, 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.

Condition or disease Intervention/treatment Phase
Hepatic Cancer Drug: Galactose Drug: Standard Treatment Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparison of Direct Peritoneal Resuscitation Plus Conventional Resuscitation Versus Conventional Resuscitation Alone in Patients Undergoing Hepatic Resection for Cancer
Study Start Date : September 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Active Comparator: Standard treatment
Standard liver surgery and post-operative treatment
Drug: Standard Treatment
Standard liver surgery.

Experimental: Galactose
Standard liver surgery with direct peritoneal resuscitation with galactose after surgery.
Drug: Galactose
After surgery, galactose will be dripped into the belly for up to 24 hours after surgery




Primary Outcome Measures :
  1. Morbidity [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Cytokine levels [ Time Frame: Six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882218


Locations
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United States, Kentucky
Norton Hospital
Louisville, Kentucky, United States, 40202
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Jason Smith, MD U Louisville
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Responsible Party: Jason Smith, MD, University of Louisville
ClinicalTrials.gov Identifier: NCT01882218    
Other Study ID Numbers: 12.0262
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jason Smith, University of Louisville:
Liver cancer
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases