Bilirubinaemia, Hepatectomy, Jaundice, Liver Dysfunction
Conditions
Keywords
Dexamethasone, Liver Dysfunction, Hepatectomy, Bilirubinaemia, Jaundice
Brief summary
The investigators were aiming to evaluate whether dexamethasone administration accelerates the recovery from hepatectomy-related jaundice and decreases the rates of post-hepatectomy liver failure and its safety in the subjects who developed elevated serum total bilirubin.
Detailed description
Post-operative jaundice is one of the most common complications after hepatectomy for various liver tumors. Glucocorticoids, including dexamethasone, prednisolone, and methylprednisolone, were widely used to treat jaundice in the patients with severe hepatitis, liver dysfunction or liver failure. It was reported that glucocorticoids decrease the rates of liver dysfunction or mortality in those patients. However, whether post-operative glucocorticoids administration alleviated jaundice or deceased the rates of post-hepatectomy liver failure (PLF) yet to be determined. In this study, the investigators were aiming to evaluate whether dexamethasone administration accelerates the recovery from hepatectomy-related jaundice and decreases the rates of PLF and its safety in the subjects who developed elevated serum TB.
Interventions
DRUGDexamethasone
Dexamethasone 10 mg iv for 2 days; then 5 mg iv for 1 day
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients underwent open hepatectomy for liver tumors * Preoperative liver function was Child-Pugh A, and the liver shear wave elastography (SWE) \< 30 kPa * Postoperative serum total bilirubin \> 2.5 ULN in 7 days after hepatectomy
Exclusion criteria
* Patients with hilar cholangiocarcinoma or other disease with obstructive jaundice * Complicating disease with severe dysfunction in respiratory or circulation system or kidney. * Patients with contraindication of glucocorticoids, including severe infection, active GI bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| period in days from the day serum total bilirubin (TB) >=2.5 ULN to the day TB decreased to 1.5 ULN | up to 30 days after hepatectomy |
Secondary
| Measure | Time frame |
|---|---|
| The dynamic change of serum total bilirubin | up to 30 days after hepatectomy |
| length of hospital stay | up to 30 days after surgery |
| inhospital expenses | up to 30 days after surgery |
| post-operative complications, including postoperative liver failure, infection and GI bleeding | up to 30 days after surgery |
| The dynamic change of serum glutamine aminotransferase | up to 30 days after surgery |
Countries
China
Outcome results
None listed