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临床试验/NCT06552208
NCT06552208已完成不适用

Elaboration of a Prognostic Score Based on Patients With Malignant Biliary Obstruction

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 372 人开始时间: 2021年7月15日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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