Prediction of Intraoperative Blood Loss and Postoperative Recovery by Liver Stiffness Measurement (Fibroscan®) in Right Hepatectomy

Liver Malignancy Clinical Trial

Official title:

Prediction of Intraoperative Blood Loss and Postoperative Recovery by Liver Stiffness Measurement (Fibroscan®) in Right Hepatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483859
• Other study ID #: 1-2011-0053
• Status: Completed
• Phase: N/A
• First received: November 24, 2011
• Last updated: July 14, 2015
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France) is a newly introduced noninvasive tool that generates an elastic wave using a vibrator applied to the thoracic wall at the level of the right lobe of the liver and measures the prolongation velocity of the wave, which is directly associated with liver stiffness (LS). Although recent advances in surgical techniques and perioperative management have made with established perioperative management have now made it possible to perform hepatectomies as a safe procedure with minimum mortality, the possibility of massive blood loss and resultant transfusion during hepatectomy still exist. The objective of this research was to identify the role of liver stiffness measurement for the prediction of intraoperative blood loss and postoperative recovery after elective right hepatectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients undergoing right hepatectomy between August 2007 and July 2011

Exclusion Criteria:

• patients undergoing right hepatectomy without preoperative liver stiffness measurement

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Liver Malignancy

Intervention

Other:
• preoperative liver stiffness measurement
Liver stiffness measurement (LSM) using Fibroscan is a newly introduced noninvasive tool that generates an elastic wave using a vibrator applied to the thoracic wall at the level of the right lobe of the liver and measures the prolongation velocity of the wave, which is directly associated with liver stiffness (LS).

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation between the value of liver stiffness measurement and intraoperative blood loss during right hepatectomy	The investigators will investigate the value of liver stiffness measurement and intraoperative blood loss during right hepatectomy through chart review. The investigators will analyze the correlation between the value of liver stiffness measurement and intraoperative blood loss during right hepatectomy	Participants will be followed for perioperative period, approximate 6 weeks through chart review.	No