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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Current Primary Outcome: recurrence [ Time Frame: 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: operation time [ Time Frame: 1 day ]

Original Secondary Outcome: Same as current

Information By: Second Affiliated Hospital of Xi'an Jiaotong University

Dates:
Date Received: June 19, 2014
Date Started: June 2014
Date Completion: September 2021
Last Updated: June 26, 2014
Last Verified: June 2014