Hepatocellular carcinoma, Intrahepatic cholangiocarcinoma, Metastatic liver cancer, Perihilar cholan
Conditions
Interventions
Olprinone is administered during laparoscopic hepatectomy.
Sponsors
Sugiura Teiichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) A laparoscopic hepatectomy is scheduled. (2) The registered age is between 18 and 75 years old. (3) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is 0 or 1. (4) There's no obstructive ventilatory impairment (Forced Expiratory Volume in 1 second (FEV1.0%) is >= 70%). (5) There's no history of angina or myocardial infarction. (6) No moderate to severe valvular disease (based on the findings from a transthoracic echocardiogram). (7) All the following conditions are met: White blood cell count: between 2,500/mm3 and 10,000/mm3 Platelet count >=100,000/mm3 AST <=100IU/L ALT <=100IU/L Total bilirubin <=2.0 mg/dL (<=4.0mg/dL in cases with jaundice) Serum creatinine <=1.0mg/dL (8) Written consent for trial participation has been obtained from the patient.
Exclusion criteria
Exclusion criteria: (1) Cases with a history of arrhythmia. (Premature ventricular contractions are not included.) (2) Cases where surgery is conducted without discontinuing antiplatelet drugs. (3) Cases with a history of hypersensitivity to PDEIII inhibitors. (4) Cases deemed unsuitable for this trial by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT : Dose Limiting Toxicity 1) During surgery: Rise in blood pressure due to positive inotropic effects that doesn't respond to antihypertensive drugs (systolic blood pressure >180mmHg). Drop in blood pressure due to vasodilatory effects that doesn't respond to pressor agents (diastolic blood pressure 140 beats/minute). 2) From the end of surgery to 24 hours post-operation: Occurrence of arrhythmias (paroxysmal atrial tachycardia, atrial fibrillation, atrial flutter, ventricular tachycardia (including Torsade de pointes), ventricular fibrillation). Excessive tachycardia (heart rate >140 beats/minute). Presence or absence of renal dysfunction immediately after surgery (upon ICU admission) (increase in serum creatinine (Cr): proportion of Cr>2.00). 3) From the day after surgery: Presence or absence of renal dysfunction on the 1st, 3rd, and 5th days post-operation (increase in serum creatinine (Cr): proportion of Cr>2.00). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Temporal changes in central venous pressure (measured every 20 seconds from the start of the surgery, but particularly evaluated at the following times): At the start of surgery Before olprinone loading Before liver transection During liver transection: Since the duration of liver transection varies from case to case, mean and median values are used. After liver transection At the end of surgery 2) The proportion of reduction in central venous pressure just before and during liver resection. 3) Hemodynamic parameters obtained with the FloTrac System(measured every 20 seconds from the start of surgery, but especially evaluated at the same times as the above central venous pressure): Cardiac output Cardiac index Stroke volume Stroke volume index Stroke volume variation Systemic vascular resistance Systemic vascular resistance index 4) Observed arterial pressure(Recorded every 20 seconds from the start of the operation, but especially assessed at the same time as the central venous pressure above). 5) The amount of blood loss during surgery and blood loss during liver resection. | — |
Contacts
Public ContactYuya Miura
Shizuoka Cancer Center
Outcome results
None listed