The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

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ClinicalTrials.gov Identifier: NCT02991339

Recruitment Status : Completed

First Posted : December 13, 2016

Last Update Posted : June 10, 2021

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Sponsor:

Information provided by (Responsible Party):

Hui-Chuan Sun, Shanghai Zhongshan Hospital

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

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Study Type :	Interventional (Clinical Trial)
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 :	June 2016
Actual Primary Completion Date :	December 2017
Actual Study Completion Date :	July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate

U.S. FDA Resources

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 Name: 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 [ Time Frame: up to 30 days after hepatectomy ]

Secondary Outcome Measures :

The dynamic change of serum total bilirubin [ Time Frame: up to 30 days after hepatectomy ]
length of hospital stay [ Time Frame: up to 30 days after surgery ]
inhospital expenses [ Time Frame: up to 30 days after surgery ]
post-operative complications, including postoperative liver failure, infection and GI bleeding [ Time Frame: up to 30 days after surgery ]
The dynamic change of serum glutamine aminotransferase [ Time Frame: up to 30 days after surgery ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991339

Locations

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China, Shanghai
180 Fenglin Road
Shanghai, Shanghai, China, 200032

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

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

More Information

Publications of Results:

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.

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.

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.

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.

Other Publications:

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.

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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:	December 13, 2016 Key Record Dates
Last Update Posted:	June 10, 2021
Last Verified:	June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Hui-Chuan Sun, Shanghai Zhongshan Hospital:


Dexamethasone Liver Dysfunction Hepatectomy Bilirubinaemia Jaundice

Additional relevant MeSH terms:

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Liver Diseases Jaundice Hyperbilirubinemia Pathologic Processes Skin Manifestations Digestive System Diseases Dexamethasone Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Antiemetics	Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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