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

August 29, 2018 updated by: Lu Wang, MD, PhD, Fudan University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 days after surgery
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)
5 days after surgery
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.
5 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lu Wang, MD, Fudan University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LSD-2017-1-ICG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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