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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jeong-Rim LEE, Yonsei University
ClinicalTrials.gov Identifier:
NCT01483859
First received: November 24, 2011
Last updated: November 29, 2011
Last verified: November 2011
  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


Estimated Enrollment: 45
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01483859

Contacts
Contact: Jeong-Rim LEE, MD, PhD 82-2-2227-3840 MANYA@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jeong-Rim LEE, MD, PhD    82-2-2227-3840    MANYA@yuhs.ac   
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: November 29, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 01, 2014