Randomized Clinical Trial Comparing Laparoscopic and Open Esophagogastric Devascularization and Splenectomy for Portal Hypertension
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- recurrence
研究概览
简要总结
Many patients with portal hypertension require surgical treatment each year,and Hassab's operation, or esophagogastric devascularization and splenectomy, is an elective procedure. In recent years,laparoscopic esophagogastric devascularization and splenectomy has been used to treat portal hypertension. However, the potential benefits remain to be demonstrated in the context of a randomized trial. In this study, 120 patients will randomize equally receiving laparoscopic or open esophagogastric devascularization and splenectomy. Inclusion criteria included: platelet count < 50×109/ml, esophageal and gastric varices revealed, agreeing the informed consent. PerioperativeOutcomes are: technical success, blood loose and infusion during the operation, recurrent varicose veins on gastroscopy examination, patterns of reflux on duplex ultrasound examination, complications, platelet and liver function variation, length of hospital stay. Follow-up will last 5 years, and gastroscopy and ultrasonic will perform at 3 months, 1 year, 3 years, and 5 years. Further more, this study was proved by the ethical committee of second hospital of Xi'an jiaotong university.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The cause of portal hypertension was cirrhosis
- •Platelet count < 50×109/ml
- •Esophageal and gastric varices revealed
- •Agreeing the informed consent.
排除标准
- •Thrombosis present in portal vein preoperatively
- •Accompany with liver cancer
- •Operation procedure is laparoscopy converse to open
- •Patients disagree with the study.
研究组 & 干预措施
open group
the patients under go the open esophagogastric devascularization and splenectomy
干预措施: open surgical procedure (Procedure)
laparoscopic group
the patients under go the laparoscopic esophagogastric devascularization and splenectomy
干预措施: laparoscopic surgical procedure (Procedure)
结局指标
主要结局
recurrence
时间窗: 5 years
gastroesophageal varices recurrence rate
次要结局
- operation time(1 day)
