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The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

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ClinicalTrials.gov Identifier: NCT02991339
Recruitment Status : Unknown
Verified December 2016 by Hui-Chuan Sun, Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Hui-Chuan Sun, Shanghai Zhongshan Hospital

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 Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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 :
  1. The dynamic change of serum total bilirubin [ Time Frame: up to 30 days after hepatectomy ]
  2. length of hospital stay [ Time Frame: up to 30 days after surgery ]
  3. inhospital expenses [ Time Frame: up to 30 days after surgery ]
  4. post-operative complications, including postoperative liver failure, infection and GI bleeding [ Time Frame: up to 30 days after surgery ]
  5. The dynamic change of serum glutamine aminotransferase [ Time Frame: up to 30 days after surgery ]


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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

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


Contacts
Contact: Cheng Huang, MD +8613816882332 huang.cheng@zs-hospital.sh.cn
Contact: Xiao-Dong Zhu, MD +8613817257515 zhu.xiaodong@zs-hospital.sh.cn

Locations
China, Shanghai
180 Fenglin Road Recruiting
Shanghai, Shanghai, China, 200032
Contact: Mei-Ling Li, BS       livercongress@zs-hospital.sh.cn   
Principal Investigator: Hui-Chuan Sun, MD         
Sub-Investigator: Cheng Huang, MD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Principal Investigator: Hui-Chuan Sun, MD Liver Cancer Insitute and Zhongshan Hospital, Fudan University

Publications of Results:
Other Publications:
Responsible Party: Hui-Chuan Sun, Deputy Director of the Department of Liver Surgery, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02991339     History of Changes
Other Study ID Numbers: ZS-SHC-DAJ
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
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:
Jaundice
Liver Diseases
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Digestive System Diseases
Dexamethasone acetate
Dexamethasone
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