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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01483859

First Posted: December 1, 2011

Last Update Posted: July 16, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Jeong-Rim LEE, Yonsei University

Purpose

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.

Condition	Intervention
Liver Malignancy	Other: preoperative liver stiffness measurement


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label)
Official Title:	Prediction of Intraoperative Blood Loss and Postoperative Recovery by Liver Stiffness Measurement (Fibroscan®) in Right Hepatectomy

Resource links provided by NLM:

MedlinePlus related topics: Bleeding

U.S. FDA Resources

Further study details as provided by Jeong-Rim LEE, Yonsei University:

Primary Outcome Measures:

The correlation between the value of liver stiffness measurement and intraoperative blood loss during right hepatectomy [ Time Frame: Participants will be followed for perioperative period, approximate 6 weeks through chart review. ]
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


Enrollment:	45
Study Start Date:	September 2011
Study Completion Date:	December 2012
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
right hepatectomy with preoperative LSM patients undergoing right hepatectomy with preoperative LSM between August 2007 and July 2011	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). Other Name: Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France)

Arms

Assigned Interventions

right hepatectomy with preoperative LSM

patients undergoing right hepatectomy with preoperative LSM between August 2007 and July 2011

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).

Other Name: Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients undergoing right hepatectomy between August 2007 and July 2011

Exclusion Criteria:

patients undergoing right hepatectomy without preoperative liver stiffness measurement

Contacts and Locations

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): NCT01483859

Locations


Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Severance Hospital
Seoul, Korea, Republic of

Sponsors and Collaborators

Yonsei University

More Information


Responsible Party:	Jeong-Rim LEE, Assistant Professor, Yonsei University
ClinicalTrials.gov Identifier:	NCT01483859 History of Changes
Other Study ID Numbers:	1-2011-0053
First Submitted:	November 24, 2011
First Posted:	December 1, 2011
Last Update Posted:	July 16, 2015
Last Verified:	July 2015

Additional relevant MeSH terms:


Liver Extracts Hematinics

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