Preoperative risk assessment for post-hepatectomy liver failure (PHLF) by FLR, ICG and indocycanine green and development of a model predicting PHLF using all three modalities.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To investigate the effectiveness of combination of FLR, ALBI score, APRI score, ICG and Fibroscan in predicting incidence of PHLF, Severity of PHLF and peri-operative mortality in Posthepatectomy liver failure
研究概览
简要总结
This study aims to improve how doctors predict the risk of post-hepatectomy liver failure (PHLF), a serious complication that can occur after liver surgery. While liver surgery has become much safer over the years, some patients still experience complications, including liver failure, which can be life-threatening. Currently, doctors use various methods to assess liver function before surgery, but no single approach is entirely reliable.
This study focuses on combining three key preoperative tests—Future Liver Remnant (FLR) measurement, Fibroscan (a non-invasive liver stiffness test), and the Indocyanine Green (ICG) clearance test, ALBI (Albumin-bilirubin) score and APRI (Aspartate transaminase- Platelet Index) score —to develop a better way to predict PHLF and improve patient outcomes.
The study will involve 100 patients (50 as prospective and 50 as retrospective) undergoing liver surgery at the hospital. Before surgery, each patient will undergo FLR calculation using imaging techniques, a Fibroscan to assess liver stiffness, and an ICG test, which measures how well the liver processes a special dye and ALBI and APRI score calculation.
These results will then be analyzed and compared with actual surgical outcomes to determine how effectively these tests can predict PHLF. The goal is to see whether combining these methods provides a more accurate prediction than using just one or two, ultimately helping surgeons make better decisions before surgery. Since this is an observational study, no experimental treatments will be introduced. Patients will undergo their planned liver surgery with the usual preoperative assessments, and the study will simply analyze the data collected to improve future patient care. Researchers expect to find that using all three tests together will provide a clearer and more accurate picture of liver function, allowing doctors to identify high-risk patients more reliably.
This could lead to better decision-making, potentially reducing complications and improving survival rates. Patients participating in the study will provide informed consent, and all personal information will be kept strictly confidential. Any serious complications that arise will be reported immediately and handled according to hospital safety guidelines. The ultimate aim is to develop a reliable risk prediction model using these three preoperative tests, which could become a valuable tool for surgeons in planning safer liver surgeries and improving patient outcomes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •1.All patients over 18 years of age, planned for major hepatectomies 2.Patient planned for minor hepatectomies, but ICG and Fibroscan deemed necessary after multi-disciplinary discussion in view of cirrhosis.
排除标准
- •Minor Hepatectomies (except the above) 2.Patient who refused to give valid consent for the study 3.Patients who are unfit for surgery due to medical comorbidities 4.Patients with Obstructive Jaundice (ICG clearance impaired).
结局指标
主要结局
To investigate the effectiveness of combination of FLR, ALBI score, APRI score, ICG and Fibroscan in predicting incidence of PHLF, Severity of PHLF and peri-operative mortality in Posthepatectomy liver failure
时间窗: till hospital stay after surgery and day 30, day 60 post surgery
次要结局
- Risk of Hepatic decompensation later(beyond 3 months after surgery)
- disease Recurrences, Overall survival, and Disease free survival after hepatectomy
- To develop a predictive model for PHLF using the modalities.(day 30, day 60 and then every 6 monthly)
研究者
Dr Mahesh Goel
Tata Memorial Hospital
