NCT02178319

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Portal Hypertension
• Liver Cirrhosis

Interventions

Type	Name	Description
PROCEDURE	open surgical procedure	open esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients
PROCEDURE	laparoscopic surgical procedure	laparoscopic esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients

Timeline

• Start date: 2014-06-01
• Primary completion: 2021-06-01
• Completion: 2021-09-01
• First posted: 2014-06-30
• Last updated: 2014-06-30

Locations

1 site across 1 country: China