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Completed

NCT Number: NCT02991339

The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

Other names: Dexamethasone Sodium Phosphate Injection

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

    Time frame: up to 30 days after hepatectomy

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 13, 2016
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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