A Model Based on Resected Normal Liver Parenchymal Volume（RNLV）to Predict the Risk of Post-Hepatectomy Liver Failure (PHLF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,600
- 试验地点
- 3
- 主要终点
- Probability of PHLF was predicted with our individual model based on RNLV.
研究概览
简要总结
The post-hepatotectomy liver failure (PHLF) is still the most worrisome complication of hepatic resection. Surgeons have always been making efforts to preoperatively predict PHLF using kinds of techniques, scoring systems, and variables. The investigators of this study tried to create an individual predictive model based on the variable, resected normal parenchymal volume (RNLV), then assessing the performance and value of the model in clinical practice.
详细描述
The investigator launched a large sample-size and retrospective study, enrolling more than a thousand consecutive patients diagnosed with hepatocellular carcinoma (HCC) and intracholangiocarcinoma (ICC) underwent hepatotectomy from the investigator's center. The primary aim of study was to identify whether there was strong correlation between RNLV and PHLF, and the second aim was to further build a combination model based on RNLV and evaluate the value of predicting PHLF in clinical practice. The investigators attached same importance to RNLV, compared to future liver remnant, especially for patients with massive tumors and multiple tumors. The investigators hyperthesized that RNLV could be an indicative variable for surgical safety, and help to form a diversifying method to comprehensively assess the risk of PHLF preoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •selective hepatectomies;
- •histologically confirmed as HCC and ICC
- •complete and accessible data
排除标准
- •any history of Associated Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS)
- •any history of portal vein embolism (PVE)
- •any history of tumor rupture
- •emergency surgery
- •pathologically diagnosed with neither HCC nor ICC
- •concomitant resection of gastrointestinal organs, spleenectomy or other organs
研究组 & 干预措施
PHLF group
One group was defined as post-operative liver failure accroding to the PHLF definition of 50-50 criteria and ISGLS criteria.
干预措施: the different definitions of PHLF according to 50-50 criteria and ISGLS criteria (Diagnostic Test)
No PHLF group
One group was defined as no post-operative liver failure accroding to the PHLF definition of 50-50 criteria nor ISGLS criteria.
结局指标
主要结局
Probability of PHLF was predicted with our individual model based on RNLV.
时间窗: postoperative day 1 to day 30.
In our center, an increase international normalized ratio greater than 1.15 and concomitant hyperbilirubinemia more than 23μmol/L on or after postoperative day 5 would be defined as PHLF, according to the International Study Group of Liver Surgery.
次要结局
未报告次要终点
研究者
Yuan-Yuan Wang
a clinical resident of general surgery department
National Natural Science Foundation of China