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

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: Unknown
• Conditions: Predictive Value of ICG Clearance Measurement During Selective Hepatic Vascular Trial Clamping on Remnant Liver Function After Anatomic Liver Resection
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 170

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Lu Wang, MD; Phone Number: 086-18121299357; Email: w.lr@hotmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHLF	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	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	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

• Sponsor: Fudan University
• Investigators: Study Director: Lu Wang, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): August 31, 2019
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID 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