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The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

Primary Purpose

Liver Dysfunction, Hepatectomy, Bilirubinaemia

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Dysfunction focused on measuring Dexamethasone, Liver Dysfunction, Hepatectomy, Bilirubinaemia, Jaundice

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 180 Fenglin Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dexamethasone

control

Arm 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.

Patients are not treated with glucocorticoids.

Outcomes

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

Secondary Outcome Measures

The dynamic change of serum total bilirubin
length of hospital stay
inhospital expenses
post-operative complications, including postoperative liver failure, infection and GI bleeding
The dynamic change of serum glutamine aminotransferase

Full Information

First Posted
November 25, 2016
Last Updated
June 9, 2021
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02991339
Brief Title
The Effects of Dexamethasone Administration on Jaundice Following Liver Resection
Official Title
The Effects of Dexamethasone Administration on Jaundice Following Liver Resection: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Dysfunction, Hepatectomy, Bilirubinaemia, Jaundice
Keywords
Dexamethasone, Liver Dysfunction, Hepatectomy, Bilirubinaemia, Jaundice

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm 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.
Arm Title
control
Arm Type
No Intervention
Arm Description
Patients are not treated with glucocorticoids.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dexamethasone Sodium Phosphate Injection
Intervention Description
Dexamethasone 10 mg iv for 2 days; then 5 mg iv for 1 day
Primary Outcome Measure Information:
Title
period in days from the day serum total bilirubin (TB) >=2.5 ULN to the day TB decreased to 1.5 ULN
Time Frame
up to 30 days after hepatectomy
Secondary Outcome Measure Information:
Title
The dynamic change of serum total bilirubin
Time Frame
up to 30 days after hepatectomy
Title
length of hospital stay
Time Frame
up to 30 days after surgery
Title
inhospital expenses
Time Frame
up to 30 days after surgery
Title
post-operative complications, including postoperative liver failure, infection and GI bleeding
Time Frame
up to 30 days after surgery
Title
The dynamic change of serum glutamine aminotransferase
Time Frame
up to 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Chuan Sun, MD
Organizational Affiliation
Liver Cancer Insitute and Zhongshan Hospital, Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
180 Fenglin Road
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21236455
Citation
Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, Buchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.
Results Reference
background
PubMed Identifier
20940288
Citation
Mathurin P, O'Grady J, Carithers RL, Phillips M, Louvet A, Mendenhall CL, Ramond MJ, Naveau S, Maddrey WC, Morgan TR. Corticosteroids improve short-term survival in patients with severe alcoholic hepatitis: meta-analysis of individual patient data. Gut. 2011 Feb;60(2):255-60. doi: 10.1136/gut.2010.224097. Epub 2010 Oct 12.
Results Reference
result
PubMed Identifier
26176387
Citation
Thursz MR, Forrest EH, Ryder S; STOPAH investigators. Prednisolone or Pentoxifylline for Alcoholic Hepatitis. N Engl J Med. 2015 Jul 16;373(3):282-3. doi: 10.1056/NEJMc1506342. No abstract available.
Results Reference
result
PubMed Identifier
24224656
Citation
Chen JF, Wang KW, Zhang SQ, Lei ZY, Xie JQ, Zhu JY, Weng WZ, Gao ZL, Lin BL. Dexamethasone in outcome of patients with hepatitis B virus-related acute-on-chronic liver failure. J Gastroenterol Hepatol. 2014 Apr;29(4):800-6. doi: 10.1111/jgh.12454.
Results Reference
result
PubMed Identifier
11231856
Citation
Yamashita Y, Shimada M, Hamatsu T, Rikimaru T, Tanaka S, Shirabe K, Sugimachi K. Effects of preoperative steroid administration on surgical stress in hepatic resection: prospective randomized trial. Arch Surg. 2001 Mar;136(3):328-33. doi: 10.1001/archsurg.136.3.328.
Results Reference
result

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The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

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