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Trial record 34 of 33704 for:    value

Predictive Value of Intraoperative Indocyanine Green Clearance Test After Partially Blood Flow Blocking in Postoperative Liver Reserve

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ClinicalTrials.gov Identifier: NCT03654183
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Lu Wang, MD, PhD, Fudan University

Brief Summary:
Predictive value of intraoperative indocyanine green clearance measurement during selective hepatic vascular trial clamping on remnant liver function after anatomic liver resection.

Condition or disease Intervention/treatment
Predictive Value of ICG Clearance Measurement During Selective Hepatic Vascular Trial Clamping on Remnant Liver Function After Anatomic Liver Resection Diagnostic Test: Indocynine green clearance test

Detailed Description:
In this study, we will prospectively and consecutively enroll patients undergoing hemi-hepatectomy or lateral segmentectomy. ICG clearance measurements will be performed both preoperatively and intraoperatively under partial blood blocking of resecting segments. This study will use PHLF, C-D grade, MELD grade and postoperative hospital stay to evaluate and compare the potential of these measurements to predict postoperative liver function. Accordingly, we are supposed to demonstrate the sensitivity and specificity of intraoperative ICG clearance measurement in detecting postoperative liver failure. Furthermore, cut-off values would be defined to identify high, medium or low risk patients.

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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Value of Intraoperative Indocyanine Green Clearance Test After Partially Blood Flow Blocking in Postoperative Liver Reserve: a Prospective Study
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Indocynine green clearance test
    Indocyanine green clearance was determined by non-invasive pulse spectrophotometry (NIHON KOHDEN™; Pulse Dye Densito-Graph Analyzer, Japan).


Primary Outcome Measures :
  1. PHLF [ Time Frame: 5 days after surgery ]
    Severe posthepatectomy liver failure (PHLF) was defined as Serum total bilirubin more than 120umol/L, prothrombin activity more than 50% or PHLF grade B/C. PHLF grade was defined by the International Study Group of Liver Surgery (ISGLS). Grade A PHLF requires no change of the patient's clinical management. The clinical management of patients with grade B PHLF deviates from the regular course but does not require invasive therapy. The need for invasive treatment defines grade C PHLF.

  2. MELD score [ Time Frame: 5 days after surgery ]
    The equation for the model for end-stage liver disease (MELD) score = 3.8×loge(bilirubin [mg/dL])+11.2×loge(INR)+9.6×loge(creatinine [mg/dL])+6.4×(etiology: 0 if cholestatic or alcoholic, 1 otherwise)

  3. Clavien-Dindo grade [ Time Frame: 5 days after surgery ]
    Grade I surgical complication was defined as any deviation from the normal postoperative course without the need for pharmacological treatment of surgical, endoscopic, and radiological interventions; grade II surgical complication was defined as requiring pharmacological treatment with drugs other than such allowed for grade I complications, blood transfusions and total parenteral nutrition are also included; grade III surgical complication was defined as requiring surgical, endoscopic or radiological intervention; grade IV surgical complication was defined as life-threatening complication requiring IC/ICU management; and grade V surgical complication was defined as death of a patient.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
(a) patients scheduled to undergo major anatomic liver resection according to clinical assessment, (b) patients'expectation of life longer than 3 months, and (c) age between 18 to 80 years old.
Criteria

Inclusion Criteria:

  • (a) patients scheduled to undergo major anatomic liver resection according to clinical assessment, (b) patients'expectation of life longer than 3 months, and (c) age between 18 to 80 years old.

Exclusion Criteria:

  • (a) patients could not tolerate liver surgery according to preoperative tests, (b) with no need for major liver resection according to intraoperative assessment, (c) had any contraindications to liver surgery, or (d) ICG metabolic disorder.

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): NCT03654183


Contacts
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Contact: Lu Wang, MD 086-18121299357 w.lr@hotmail.com

Locations
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China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China
Contact: Lu Wang, MD    086-18121299357    w.lr@hotmail.com   
Sponsors and Collaborators
Fudan University
Investigators
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Study Director: Lu Wang, MD Fudan University

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Responsible Party: Lu Wang, MD, PhD, Head of Liver Surgery Department, Fudan University
ClinicalTrials.gov Identifier: NCT03654183     History of Changes
Other Study ID Numbers: LSD-2017-1-ICG
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No