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临床试验/NCT03396796
NCT03396796已完成不适用

Modified Vagus Nerve-preserving Versus Conventional Laparoscopic Splenectomy and Azygoportal Disconnection

Yangzhou University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月9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
60
试验地点
1
主要终点
Delayed gastric emptying

研究概览

简要总结

This study aimed to evaluate whether vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection is effective and safe, and to determine whether a reduction in the incidence of postoperative complications of the digestive system improves postoperative quality of life compared with conventional laparoscopic splenectomy and azygoportal disconnection.

详细描述

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline parameter will be recorded and the patient will be randomized into either interventional (vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection) or control (conventional laparoscopic splenectomy and azygoportal disconnection) 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, 9, and 12 after operation, electron gastroscopy examination for delayed gastric emptying will be done for all patients. Postoperative complications of the digestive system (including diarrhea, epigastric fullness, bloating, nausea, and vomiting), liver and renal function, and body weight will be recorded at the seventh day, months 1, 3, 6, 9, and 12 after operation. Then one year monitoring will be done 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
Prevention
盲法
Double (Investigator, Outcomes Assessor)

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

入选标准

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

排除标准

  • Delayed gastric emptying
  • 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

Delayed gastric emptying

时间窗: 1 year

Proportions of patients who will suffer from delayed gastric emptying in both groups.

次要结局

  • Portal vein system thrombosis(1 year)
  • Overall survival(1 year)
  • Body weight(1 year)
  • Hepatic decompensation(1 year)
  • Postoperative complications of the digestive system(1 year)
  • Hepatocellular carcinoma(1 year)

研究者

发起方
Yangzhou University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guo-Qing Jiang

Clinical Professor

Yangzhou University

研究点 (1)

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