The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Dexamethasone Administration on Jaundice Following Liver Resection: a Randomized Controlled Trial

Conditions
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Liver Dysfunction, Hepatectomy, Bilirubinaemia, Jaundice

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>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. | Drug: Dexamethasone<br>* Dexamethasone 10 mg iv for 2 days; then 5 mg iv for 1 day<br>* Other names: Dexamethasone Sodium Phosphate Injection;|
| No Intervention: control<br>Patients are not treated with glucocorticoids. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexamethasone, Liver Dysfunction, Hepatectomy, Bilirubinaemia, Jaundice