Clinical Management of Patients With Cirrhotic Portal Hypertension Based on the Noninvasive Portal Pressure Gradient (vPPG) Detecting Software, a Prospective and Controlled Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- The morbidity of cirrhotic decompensated events
研究概览
简要总结
The aim of this study is to investigate the possibilities and effectiveness of managing cirrhotic portal hypertension using the non-invasive portal pressure gradient (PPG) detecting software. In this study, the three-dimensional reconstruction and natural follow-up methods have been respectively applied in the experimental (1st) and active comparator (2nd) group. The virtual PPG is calculated with anatomical and hemodynamic information of portal system collected by ultrasound and CT tests. Cirrhosis patients in the 1st group, with calculated vPPG values, are managed with upper GI endoscopic results. Besides, patients in the 2nd group, are managed according to the most updated Chinese clinical guideline for cirrhotic portal hypertension, namely, patients with either liver stiffness measurement (LSM) >15kPa or PLT count <150*10^9 should be screened and treated with upper GI endoscopy. The morbidity of decompensated cirrhotic events and mortality of patients in two arms will be compared. The cutoff values of vPPG to spare endoscopies with low missed VNT (varices needing treatment) are preliminarily determined with the cohort data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients (Shanghai Tongji Hospital) with cirrhosis, which is confirmed by the imaging tests (upper abdominal ultrasound/CT/MRI) or liver biopsy pathology.
排除标准
- •Portal vein embolism;
- •Splenectomy;
- •Hepatic encephalopathy;
- •Hepatic space occupying lesions (such as hepatic cysts, hemangiomas, etc.) with diameter > 3cm and local compression effect;
- •Contraindications of enhanced CT test, such as iodine allergy, peripheral veins are too thin to inject contrast medium;
- •Contraindications of upper GI endoscopy
结局指标
主要结局
The morbidity of cirrhotic decompensated events
时间窗: 2 years
The occurence rate of cirrhotic decompensated events of enrolled patients
The mortality of cirrhosis
时间窗: 2 years
Patients who die because of cirrhosis
次要结局
- Spared endoscopies(2 years)
- Number of missed VNT(2 years)
研究者
Changqing Yang
Principal Investigator,Head of Gastroenterology and Hepatology, Chief Physician, Professor
Shanghai Tongji Hospital, Tongji University School of Medicine