Patients with liver metastases (mainly colorectal cancer) who will be undergoing major hepatic resection (3 or more liver segments) which have been treated with neoadjuvant chemotherapy.
Conditions
Interventions
Trade Name: FRENADOL COMPLEX
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: PARACETAMOL
Other descriptive name: N02BE01
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
INSTITUTO DE INVESTIGACION SANITARIA LA FE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group volunteers: volunteer subjects without associated liver pathology. Group patients: Patients with liver metastases (mainly colorectal cancer) who will be undergoing major hepatic resection (3 or more liver segments) which have been treated with neoadjuvant chemotherapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Volunteer Group: Under 18 years, pregnant and lactating women, allergy to any of the active substances or excipients, allergy to acetylsalicylic acid, associated liver disease (cirrhosis, hepatitis, liver tumor pathology), moderate alcohol consumption, renal failure (creatinine 1.2mg/dl or GFR of less than 90 ml / min), use of drugs that interfere with the hepatic metabolism of the active Patients Group: Under 18 years, allergy to any of the active substances or excipients or indocyanine green, allergy to acetylsalicylic acid, total bilirubin high (greater than 1.1 mg / dl), liver cirrhosis, renal failure (creatinine greater than 1.2mg/dl or GFR of less than 90 ml / min), progression of metastatic disease or the appearance of other pathological conditions contraindicate study during surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effectiveness of Hepatotest in assessing preoperative liver function in patients with liver metastases who have received chemotherapy. The correlation of active ingredients and metabolites in blood and urine, and liver enzyme activity in liver biopsy will be studied.;Secondary Objective: Patient Group:study the metabolism of the active principles of the drug and indocyanine green test before and after chemotherapy before surgery,and determining differences.Results of HepatoTest will correlated with indocyanine green test performed before and after chemotherapy.Determine the pharmacokinetics of paracetamol active,dextromethorphan, chlorpheniramine and caffeine volunteer subjects.Liver biopsy study the amount and activity per gram of tissue of the enzymes involved in the metabolism of the active principles of the drug.To determine the relationship of the results of HepatoTest and indocyanine green test with the appearance of postoperative liver dysfunction.Determine the histological changes secondary to chemotherapy,and its relation to the type of chemotherapy received, the duration of treatment,and the occurrence of postoperative liver dysfunction.Study the correlation of preoperative HepatoTest result of hepatic enzyme activity in liver regeneration capacity;Primary end point(s): Correlation of active ingredients and metabolites in blood and urine, and liver enzyme activity in liver biopsy.;Timepoint(s) of evaluation of this end point: At the end of the clinical trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Determination of metabolites before and after chemotherapy in both tests. Compare the results of both tests before and after chemotherapy. Determine the drug pharmacokinetics in healthy volunteers;Timepoint(s) of evaluation of this end point: At the end of the clinical trial. | — |
Countries
Spain
Contacts
Public ContactUREC
INSTITUTO DE INVESTIGACION SANITARIA LA FE
Outcome results
None listed