The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02991339
Collaborator
(none)
76
Enrollment
1
Location
2
Arms
25
Actual Duration (Months)
3
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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

    1. 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

    1. The dynamic change of serum total bilirubin [up to 30 days after hepatectomy]

    2. length of hospital stay [up to 30 days after surgery]

    3. inhospital expenses [up to 30 days after surgery]

    4. post-operative complications, including postoperative liver failure, infection and GI bleeding [up to 30 days after surgery]

    5. 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:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1180 Fenglin RoadShanghaiShanghaiChina200032

    Sponsors and Collaborators

    • Shanghai Zhongshan Hospital

    Investigators

    • Principal Investigator: Hui-Chuan Sun, MD, Liver Cancer Insitute and Zhongshan Hospital, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hui-Chuan Sun, Deputy Director of the Department of Liver Surgery, Shanghai Zhongshan Hospital
    ClinicalTrials.gov Identifier:
    NCT02991339
    Other Study ID Numbers:
    • ZS-SHC-DAJ
    First Posted:
    Dec 13, 2016
    Last Update Posted:
    Jun 10, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Hui-Chuan Sun, Deputy Director of the Department of Liver Surgery, Shanghai Zhongshan Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 10, 2021