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

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

• Registration Number: NCT03654183
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-29
• Last Update Submitted: 2018-08-29
• Study First Posted: 2018-08-31
• Last Update Posted: 2018-08-31
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clavien-Dindo grade	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.
MELD score	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)
PHLF	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.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China