Prediction of Intraoperative Blood Loss and Postoperative Recovery by Liver Stiffness Measurement (Fibroscan®) in Right Hepatectomy
This study has been completed.
Sponsor:
Yonsei University
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
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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 (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01483859
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
| 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) |
Additional relevant MeSH terms:
|
Liver Extracts Hematinics |
ClinicalTrials.gov processed this record on September 27, 2016