- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01483859
Prediction of Intraoperative Blood Loss and Postoperative Recovery by Liver Stiffness Measurement (Fibroscan®) in Right Hepatectomy
July 14, 2015 updated by: Jeong-Rim LEE, Yonsei University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Severance Hospital
-
Seoul, Korea, Republic of
- Severance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients undergoing right hepatectomy between August 2007 and July 2011
Exclusion Criteria:
- patients undergoing right hepatectomy without preoperative liver stiffness measurement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: right hepatectomy with preoperative LSM
patients undergoing right hepatectomy with preoperative LSM between August 2007 and July 2011
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Participants will be followed for perioperative period, approximate 6 weeks through chart review.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
November 24, 2011
First Submitted That Met QC Criteria
November 29, 2011
First Posted (Estimate)
December 1, 2011
Study Record Updates
Last Update Posted (Estimate)
July 16, 2015
Last Update Submitted That Met QC Criteria
July 14, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-2011-0053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Malignancy
-
Meir Medical CenterUnknownFATTY LIVER | NO MALIGNANCY | NO DECOMPENSATED ILLNESSIsrael
-
Assiut UniversityNot yet recruitingValidity of Blood Pool SUV Ratio in Identification of Malignancy in Case of Diseased Liver
-
University of Michigan Rogel Cancer CenterDepartment of Health and Human Services; National Institute for Biomedical...Recruiting
-
UDA Centro Nacional Hepato-Bilio-PancreáticoUniversity Hospital, Limoges; Universidad de la Republica; INSERM UMR-S850, Limoges... and other collaboratorsTerminatedStudy of PD/PK/PG Relationships of Tacrolimus and Cyclosporin in Liver Transplant Patients (3PIGREF)End Stage Liver Disease | Diabetes | Toxicity | Rejection | Infection | MalignancyUruguay
-
Memorial Sloan Kettering Cancer CenterCivaTech OncologyActive, not recruitingAbdominal Malignancy | Pelvic MalignancyUnited States
-
Cancer Institute and Hospital, Chinese Academy...Recruiting
-
CephalonCompleted
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RecruitingMalignancyUnited States
-
University Hospital Birmingham NHS Foundation TrustNot yet recruitingMalignancyUnited Kingdom
-
University of SaskatchewanCompleted
Clinical Trials on preoperative liver stiffness measurement
-
Hepatopancreatobiliary Surgery Institute of Gansu...LanZhou University; The Central Hospital of Lishui City; Tianjin Second People... and other collaboratorsRecruitingVariceal Hemorrhage | Compensated Advanced Chronic Liver DiseaseChina
-
Arbor Research Collaborative for HealthNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingPortal Hypertension | Cholestasis | Liver Fibrosis | Biliary Atresia | Alagille Syndrome | Alpha1 Anti-Trypsin DeficiencyUnited States, Canada
-
University Hospital FreiburgRecruitingCommon Variable Immunodeficiency | Non-Cirrhotic Portal HypertensionGermany
-
Hepatopancreatobiliary Surgery Institute of Gansu...LanZhou University; Zhujiang Hospital; The Central Hospital of Lishui City; Xingtai... and other collaboratorsCompletedCompensated Advanced Chronic Liver Disease | Varices Needing TreatmentChina
-
VA Connecticut Healthcare SystemCompleted
-
Jonel TrebickaCompletedPortal Hypertension | Liver Cirrhoses
-
University Hospital, MontpellierCompleted
-
Zealand University HospitalAarhus University Hospital; University of Copenhagen; Frederiksberg University... and other collaboratorsRecruitingAlcoholism | Alcohol-Related Disorders | Fibrosis, Liver | Alcohol Use Disorder | Alcoholic Liver Disease | Alcohol AbuseDenmark
-
University of LiverpoolLiverpool Women's NHS Foundation TrustRecruitingPreterm BirthUnited Kingdom
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Pregnolia AGRecruitingPremature Birth | Preterm Birth | Diagnosis | Threatened Preterm Labor | Cervical Incompetence in Pregnancy as Antepartum Condition | Premature Labor | Cervical Incompetence, With DeliveryNetherlands