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
|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|
|Study Type :||Observational|
|Estimated Enrollment :||170 participants|
|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|
- Diagnostic Test: Indocynine green clearance test
Indocyanine green clearance was determined by non-invasive pulse spectrophotometry (NIHON KOHDEN™; Pulse Dye Densito-Graph Analyzer, Japan).
- 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.
- 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)
- 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.
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
|Contact: Lu Wang, MDemail@example.com|
|Fudan University Shanghai Cancer Center||Recruiting|
|Contact: Lu Wang, MD 086-18121299357 firstname.lastname@example.org|
|Study Director:||Lu Wang, MD||Fudan University|