Hepatic CancerPhase 4NCT01882218
Direct Peritoneal Resuscitation Plus Conventional Resuscitation
A Phase 4 study testing Galactose and Standard Treatment in people with Hepatic Cancer, run by University of Louisville at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Cancer
- What is being tested?
- Galactose and Standard Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal cancer
- Scheduled for liver resection
- 18 to 75
Who cannot join
- Chronic renal failure
- Cirrhosis
- Congestive heart failure
- Requiring portal venous embolization prior to resection
- Pregnant or nursing
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Norton Hospital
Louisville, Kentucky, 40202
University of Louisville Hospital
Louisville, Kentucky, 40202
About this study
Official title: A Comparison of Direct Peritoneal Resuscitation Plus Conventional Resuscitation Versus Conventional Resuscitation Alone in Patients Undergoing Hepatic Resection for Cancer
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.
Read the 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.
- Conditions
- Hepatic Cancer
- Being tested
- Galactose, Standard Treatment
- Keywords
- Liver cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalactoseDrug
After surgery, galactose will be dripped into the belly for up to 24 hours after surgery
Standard TreatmentDrug
Standard liver surgery.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | Standard liver surgery and post-operative treatment Receives: Drug: Standard Treatment |
| Galactose | Experimental | Standard liver surgery with direct peritoneal resuscitation with galactose after surgery. Receives: Drug: Galactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Measured: Six months
Secondary outcomes (1)
Cytokine levels
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Not feasable at this site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Smith, University of Louisville
- Investigators
- Jason Smith, MD, Principal investigator, U Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882218
- Sponsor's protocol ID
- 12.0262
- Status last verified
- May 2017
- First submitted
- 17 Jun 2013
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Direct Peritoneal Resuscitation Plus Conventional Resuscitation Versus Conventional Resuscitation Alone in Patients Undergoing Hepatic Resection for Cancer
- ClinicalTrials.gov ID
- NCT01882218
- Acronym / sponsor ID
- 12.0262
- Conditions
- Hepatic Cancer
- Keywords
- Liver cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not feasable at this site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Drug: Standard TreatmentStandard liver surgery and post-operative treatment |
| Galactose | Experimental | Drug: GalactoseStandard liver surgery with direct peritoneal resuscitation with galactose after surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Colorectal cancer
- Scheduled for liver resection
- 18 to 75
Key exclusion criteria (5 listed)
- Chronic renal failure
- Cirrhosis
- Congestive heart failure
- Requiring portal venous embolization prior to resection
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GalactoseAfter surgery, galactose will be dripped into the belly for up to 24 hours after surgery | Drug | Galactose |
| Standard TreatmentStandard liver surgery. | Drug | Standard treatment |
Primary outcome
Morbidity
Time frame: Six months
1 secondary outcome
Cytokine levels
Time frame: Six months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Smith, MD principal investigator
U Louisville
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Galactose and Standard Treatment in people with Hepatic Cancer, run by University of Louisville at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.