The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

NCT02991339 | Completed Phase 2

• 1 other identifier: ZS-SHC-DAJ
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Dysfunction; Hepatectomy; Bilirubinaemia; Jaundice

Keywords

Dexamethasone; Liver Dysfunction; Hepatectomy; Bilirubinaemia; Jaundice

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Dexamethasone

EXPERIMENTAL

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

control

NO INTERVENTION

Patients are not treated with glucocorticoids.

Interventions

Dexamethasone DRUG

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

Also known as: Dexamethasone Sodium Phosphate Injection

Dexamethasone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (5)

• 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.

  PMID: 21236455 BACKGROUND

• 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.

  PMID: 20940288 RESULT

• 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.

  PMID: 26176387 RESULT

• 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.

  PMID: 24224656 RESULT

• 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.

  PMID: 11231856 RESULT

MeSH Terms

Conditions

Liver Diseases; Hyperbilirubinemia; Jaundice

Interventions

Dexamethasone; dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Hui-Chuan Sun, MD

  Liver Cancer Insitute and Zhongshan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Liver Surgery

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: December 13, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2018
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)