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

Phase 1
Recruiting
Conditions
Hepatocellular carcinoma, Intrahepatic cholangiocarcinoma, Metastatic liver cancer, Perihilar cholan
Registration Number
JPRN-jRCTs041230110
Lead Sponsor
Sugiura Teiichi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
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

(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.

Study & Design

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