The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

Fudan University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Jaundice; Bilirubinaemia; Hepatectomy; Liver Dysfunction

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02991339

ZS-SHC-DAJ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

Dexamethasone

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone

control

No Intervention group

Description:

Patients are not treated with glucocorticoids.