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Laparoscopic Versus Open Devascularization for Portal Hypertension, a Randomized Controlled Trial

Liver Cirrhosis Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02178319
Study type Interventional
Source Second Affiliated Hospital of Xi'an Jiaotong University
Contact Yang Liu, Doctor
Phone +86-29-87679246
Email individualliu@163.com
Status Recruiting
Phase N/A
Start date June 2014
Completion date September 2021
View Details
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