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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeong-Rim LEE, Yonsei University
ClinicalTrials.gov Identifier:
NCT01483859
First received: November 24, 2011
Last updated: July 14, 2015
Last verified: July 2015
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:


Further study details as provided by 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. ] [ Designated as safety issue: No ]
    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)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jeong-Rim LEE, Assistant Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01483859     History of Changes
Other Study ID Numbers: 1-2011-0053
Study First Received: November 24, 2011
Last Updated: July 14, 2015
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on July 30, 2015