The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02991339

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Dysfunction Hepatectomy Bilirubinaemia Jaundice	Drug: Dexamethasone	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone 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 Dexamethasone 10 mg iv for 2 days; then 5 mg iv for 1 day Other Names: Dexamethasone Sodium Phosphate Injection
No Intervention: control Patients are not treated with glucocorticoids.

Arm

Intervention/Treatment

Experimental: Dexamethasone

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

Dexamethasone 10 mg iv for 2 days; then 5 mg iv for 1 day

Other Names:

Dexamethasone Sodium Phosphate Injection

No Intervention: control

Patients are not treated with glucocorticoids.

Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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