Hepatocellular Carcinoma Clinical Trial
— LIPROCESOfficial title:
Circulating Endotoxemia After Liver Resection for Hepatocellular Carcinoma in Liver Disease - Influence of Preoperative Administration of Probiotics
NCT number | NCT02021253 |
Other study ID # | 2012/130/HP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2013 |
Est. completion date | April 12, 2018 |
Verified date | May 2018 |
Source | University Hospital, Rouen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Surgical resection is one of the curative treatment modalities for HCC. Limits are
postoperative septic and liver functional complications related to an increase in bacterial
translocation and systemic endotoxemia. Bacterial translocation is a passage of bacteria and
bacterial degradation products from the intestine to the portal circulation. The endotoxemia
secondary to bacterial translocation, stimulates endothelial production of nitric oxide (NO).
NO is also a potent inducer of membrane instability, responsible for an increase in the
permeability of the vascular endothelium and intestinal mucosa, possibly contributing to a
worsening of bacterial translocation.
Probiotics are live microorganisms which when administered in adequate amounts, provide a
health benefit on the host ((Health and Nutritional Properties of Probiotics in Food
Including Powder Milk with Live Lactic Acid Bacteria - Cordoba Argentina October 2001). Data
from experimental and clinical literature show a significant effect of probiotics on the
improvement of liver function and a decrease in infectious complications in patients with
chronic liver disease. The proposed study would evaluate the effect preventive and
therapeutic in a population of surgical patients, in whom the intestinal portal and hepatic
inflammation promotes postoperative complications.
Status | Completed |
Enrollment | 64 |
Est. completion date | April 12, 2018 |
Est. primary completion date | April 12, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Agreement signed by the patient - Diagnosis of HCC confirmed - Diagnosis of liver disease (score F3 or F4) confirmed - Indication of surgical resection confirmed and validated by a specialist multidisciplinary assessment meeting of gastrointestinal oncology - Patient operable (no indication against anaesthesiological) - Resectable tumor lesion (surgical expertise) - Laboratory tests and endoscopy: No suspicion of severe portal hypertension with bleeding risk Exclusion Criteria: - Patient not willing, at risk of default of compliance, or patient can not be monitored regularly - Antibiotic extended or terminated for less than 1 month, may limit the effects of taking probiotics. - Inflammatory Bowel Disease, which could skew the results expected by taking probiotics results. |
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Rouen | Haute Normandie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the plasma concentration versus time curve (AUC) of endotoxins circulating levels | -12, 3, 12,24, 72, 120 hours at time of surgery |
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