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

NCT ID: NCT03654183

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Predictive Value of ICG Clearance Measurement During Selective Hepatic Vascular Trial Clamping on Remnant Liver Function After Anatomic Liver Resection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Indocynine green clearance test

Indocyanine green clearance was determined by non-invasive pulse spectrophotometry (NIHON KOHDEN™; Pulse Dye Densito-Graph Analyzer, Japan).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Lu Wang, MD, PhD

Head of Liver Surgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lu Wang, MD

Role: STUDY_DIRECTOR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lu Wang, MD

Role: CONTACT

Phone: 086-18121299357

Email: [email protected]

Facility Contacts

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Lu Wang, MD

Role: primary

Other Identifiers

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LSD-2017-1-ICG

Identifier Type: -

Identifier Source: org_study_id