Liver tumor Primary liver cancer, metastatic liver cancer
Conditions
Interventions
The Administration of tolvaptan 7.5 mg will be started on the second day after the hepatectomy for patients with ascites drainage of 5 ml / BW kg or more on the first day after the operation.
Sponsors
Ohdan Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for the study were required to me et all the following criteria (1) underwent hepatectomy for liver diseases (2) aged 18 years or more (3) Performance Status (PS) of the Eastern Cooper ative Oncology Group (ECOG) is 0-1 (4) the functions of major organs (bone marrow, liv er, lungs, kidneys, etc.). A) White blood cell count: 2,000 / mm3 or more B) Amount of hemoglobin: 7.0 g / dL or more C) Platelet count: 30,000 / mm3 or more D) Total bilirubin: less than 5.0 mg / dL E) Creatinine: less than 2.0 mg / dl (5) Patients who have sufficient judgment to understand the content of the research and have given their written consent to participate in this study. (6) a drainage's volume of 5 ml / BW 1 kg / day or more on the first day after surgery
Exclusion criteria
Exclusion criteria: Primary Screening (1) Patients who have been taking tolvaptan (brand name: SAMSCA) preoperatively. (2) Patients with a history of serious drug hypersensitivity or hypersensitivity to any component of tolvaptan or similar compounds. (3) Patients with no thirst or difficulty in fluid intake, anuria, or hepatic encephalopathy who have difficulty in adequate hydration. (4) Pregnant women or women who may be pregnant (5) Patients with severe (NYHA classification III or higher) ischemic heart disease or severe valvular heart disease. (6) Patients with severe hepatic cirrhosis (hepatic impairment degree C). (7) Patients with renal dysfunction (Cre>2.0) and hyperkalemia (K>5.5). (8) Patients with dyspnea requiring oxygen administration due to severe respiratory impairment (Hugh-Jones classification IV or higher), interstitial pneumonia or pulmonary fibrosis. (9) Patients with serious preoperative complications such as infection or gastrointestinal bleeding. (10) Patients who require complicated resection of other organs other than the gallbladder, gastrointestinal anastomosis, biliary reconstruction, lymph node dissection, or revascularization. (11) Patients with psychosis or psychiatric symptoms that make participation in the study difficult. (12) Other patients who are deemed inappropriate to participate in the study by the principal investigator or subinvestigators. Secondary Screening (13)Patients who do not feel thirst or have difficulty with fluid intake, anuric patients, or patients with hepatic encephalopathy who have difficulty with adequate hydration. (14) Patients who required complicated resection of other organs other than the gallbladder, gastrointestinal anastomosis, biliary reconstruction, lymph node dissection, or revascularization. (15) Patients with serious postoperative complications such as infection or gastrointestinal bleeding. (16) Other patients who are deemed inappropriate for the study by the principal investigator or a subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum perioperative weight change | — |
Secondary
| Measure | Time frame |
|---|---|
| volume of drainage abdominal girth Urine volume Postoperative complication rate (heart failure, resp iratory failure rate) The days required for the weight that increased aft er the operation decreasing to a value in preopera tion postoperative pleural effusion Total dose of albumin, total dose of FFP Type and amount of diuretic drug Postoperative hospital stay | — |
Contacts
Public ContactTsuyoshi Kobayashi
Hiroshima University Hospital
Outcome results
None listed