The Effects of Dexamethasone Administration on Jaundice Following Liver Resection
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.
|Condition or Disease||Intervention/Treatment||Phase|
|Phase 2/Phase 3|
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.
Arms and Interventions
Dexamethasone 10 mg iv on day 1 and day 2, then 5 mg iv on day 3. For the patients the serum total bilirubin did not decrease to 1.5 ULN, then 5 mg iv on day 4.
Dexamethasone 10 mg iv for 2 days; then 5 mg iv for 1 day
|No Intervention: control|
Patients are not treated with glucocorticoids.
Primary Outcome Measures
- 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 Outcome Measures
- 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]
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
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
Contacts and Locations
|1||180 Fenglin Road||Shanghai||Shanghai||China||200032|
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
- Principal Investigator: Hui-Chuan Sun, MD, Liver Cancer Insitute and Zhongshan Hospital, Fudan University
Study Documents (Full-Text)None provided.
- Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, Büchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.