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临床试验/NCT04244487
NCT04244487已完成不适用

Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection With Versus Without Intraoperative Endoscopic Variceal Ligation

Northern Jiangsu People's Hospital1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2020年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
Esophageal variceal re-bleeding

研究概览

简要总结

This study aimed to evaluate whether synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation (SVEL) is effective and safe, and to determine whether SVEL can effectively decrease the incidence of postoperative esophageal variceal re-bleeding.

详细描述

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have prior esophageal/gastroesophageal variceal bleeding will be enrolled. The baseline parameter will be recorded and the patient will be randomized into either interventional (synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation (SVEL)) or control (single vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection without intraoperative endoscopic variceal ligation (SVEL)) group. From postoperative day 3, all patients will receive 100 mg oral aspirin enteric-coated tablets (Bayer, Leverkusen, Germany) once daily for 1 year, low-molecular-weight heparin (CS Bio, Hebei, China) subcutaneously (4.100 IU/day) for 5 days, and 25 mg of oral dipyridamole (Henan Furen, Henan, China) thrice daily for 3 months. At months 3, 6, and 12 after operation, endoscopic intervention will be done for all patients. Endoscopic variceal ligation was made if the diameter of the esophageal varices was >5 mm. Postoperative complications of esophageal variceal re-bleeding and death due to re-bleeding will be recorded during the postoperative first year monitoring in the both groups as per the primary or secondary outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
  • Splenomegaly with secondary hypersplenism
  • esophageal/gastroesophageal variceal bleeding
  • No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT
  • Informed consent to participate in the study

排除标准

  • Hepatocellular carcinoma or any other malignancy,
  • Hypercoagulable state other than the liver disease related
  • DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
  • Child - Pugh C
  • Recent peptic ulcer disease
  • History of Hemorrhagic stroke
  • Pregnancy
  • Uncontrolled Hypertension
  • Age>75 yrs
  • Human immunodeficiency virus (HIV) infection

结局指标

主要结局

Esophageal variceal re-bleeding

时间窗: 1 year

Proportions of patients who will suffer from esophageal variceal re-bleeding

次要结局

  • Death due to re-bleeding(1 year)
  • Overall survival(1 year)

研究者

发起方
Northern Jiangsu People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guo-Qing Jiang

Clinical Professor

Northern Jiangsu People's Hospital

研究点 (1)

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