Clinical trial NCT02991339: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Liver Dysfunction
Hepatectomy
Bilirubinaemia
Jaundice
Keywords: Dexamethasone
Liver Dysfunction
Hepatectomy
Bilirubinaemia
Jaundice
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: period in days from the day serum total bilirubin (TB) >=2.5 ULN to the day TB decreased to 1.5 ULN
timeFrame: up to 30 days after hepatectomy
Secondary outcomes:
measure: The dynamic change of serum total bilirubin
timeFrame: up to 30 days after hepatectomy
measure: length of hospital stay
timeFrame: up to 30 days after surgery
measure: inhospital expenses
timeFrame: up to 30 days after surgery
measure: post-operative complications, including postoperative liver failure, infection and GI bleeding
timeFrame: up to 30 days after surgery
measure: The dynamic change of serum glutamine aminotransferase
timeFrame: up to 30 days after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
affiliation: Liver Cancer Insitute and Zhongshan Hospital, Fudan University
name: Hui-Chuan Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.