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Evaluation of the Safety of Olprinone for Low Central Venous Pressure Management during Open Hepatectomy

Phase 1
Recruiting
Conditions
Hepatocellular carcinoma, Intrahepatic cholangiocarcinoma, Metastatic liver cancer, Perihilar cholan
Registration Number
JPRN-jRCTs041230111
Lead Sponsor
Sugiura Teiichi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

(1) An open 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 infar ction.
(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

(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 at tending physician.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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