The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

Hepatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991339
• Other study ID #: ZS-SHC-DAJ
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2016
• Est. completion date: July 2018

Study information

• Verified date: June 2021
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bilirubinaemia
• Hepatectomy
• Hyperbilirubinemia
• Jaundice
• Liver Diseases
• Liver Dysfunction

Intervention

Drug:
• Dexamethasone
Dexamethasone 10 mg iv for 2 days; then 5 mg iv for 1 day

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. 2 — View 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, Büchler 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The dynamic change of serum total bilirubin		up to 30 days after hepatectomy
Secondary	length of hospital stay		up to 30 days after surgery
Secondary	inhospital expenses		up to 30 days after surgery
Secondary	post-operative complications, including postoperative liver failure, infection and GI bleeding		up to 30 days after surgery
Secondary	The dynamic change of serum glutamine aminotransferase		up to 30 days after surgery