Elaboration of a Prognostic Score Based on Patients With Malignant Biliary Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- Short-term survival after biliary drainage
研究概览
简要总结
Inclusion of patients with biliary drainage for inoperable malignant biliary obstruction and analysis of clinico-biological parameters
详细描述
All patients who had biliary drainage between April 1, 2014 and August 31, 2018 for inoperable malignant biliary obstruction will be included.
Clinical and biological baseline data will be recorded retrospectively. From the electronic medical records (M-Eva software), the following clinical data will be retrieved on the day of procedure: age, gender, body mass index (BMI), percentage of weight loss in the last three months, American Society of Anesthesiologists score (ASA) , Charlson score, Eastern Cooperative Oncology Group Performans Status (ECOG PS), comorbidities, cancer type, liver metastases, obstruction level, pre-procedural sepsis, type of procedure and type of stent.
Serum biological parameters will be recorded: hemoglobin, platelets, leukocytes, urea, creatinine, albumin, total bilirubin and prothrombin time, within 48 hours prior to the procedure.
The continuous variables of biological tests will be analyzed by ROC curves. The survival curves will be estimated using the Kaplan-Meier method and compared using the log-rank test. A prognostic index will be established from the variables independently associated with poor prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant Biliary obstruction : cholestasis (elevated bilirubin > 40 µmol/L or alkaline phosphatase > 1.5 time than the normal value) and dilation of biliary tract
排除标准
- •Benign obstruction
- •Post stent surgery
- •First stent placed outside Brest University Hospital
结局指标
主要结局
Short-term survival after biliary drainage
时间窗: 4 years and fifth months
30-day survival after biliary drainage
次要结局
- Prognostic score(4 years and fifth months)
