跳至主要内容
临床试验/NCT02178319
NCT02178319Unknown不适用

Randomized Clinical Trial Comparing Laparoscopic and Open Esophagogastric Devascularization and Splenectomy for Portal Hypertension

Second Affiliated Hospital of Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

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

Active Comparator

the patients under go the open esophagogastric devascularization and splenectomy

干预措施: open surgical procedure (Procedure)

laparoscopic group

Experimental

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)

研究者

发起方
Second Affiliated Hospital of Xi'an Jiaotong University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验