The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatectomy; Jaundice; Liver Dysfunction; Bilirubinaemia
• Intervention / Treatment: Drug: Dexamethasone

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: November 25, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Dexamethasone; Hepatectomy; Liver Dysfunction; Bilirubinaemia; Jaundice
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Skin Manifestations; Liver Diseases; Jaundice; Hyperbilirubinemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Dexamethasone 21-phosphate
• Other Study ID Numbers: ZS-SHC-DAJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No