The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

Phase 2

Completed

• Conditions: Jaundice; Liver Dysfunction; Bilirubinaemia; Hepatectomy
• Interventions: Drug: Dexamethasone

• Registration Number: NCT02991339
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-11-25
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-13
• Primary Completion: 2017-12
• Study Completion: 2018-07
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China