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

Not Applicable

• Conditions: Portal Hypertension; Liver Cirrhosis
• Interventions: Procedure: laparoscopic surgical procedure; Procedure: open surgical procedure

• Registration Number: NCT02178319
• Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

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 Description

Not available

Study Timeline

• Status Verified: 2014-06
• Study Start: 2014-06
• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-26
• Last Update Submitted: 2014-06-26
• Study First Posted: 2014-06-30
• Last Update Posted: 2014-06-30
• Primary Completion: 2021-06
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• The cause of portal hypertension was cirrhosis
• Platelet count < 50×109/ml
• Esophageal and gastric varices revealed
• Agreeing the informed consent.

Exclusion Criteria

• Thrombosis present in portal vein preoperatively
• Accompany with liver cancer
• Operation procedure is laparoscopy converse to open
• Patients disagree with the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic group	laparoscopic surgical procedure	the patients under go the laparoscopic esophagogastric devascularization and splenectomy
open group	open surgical procedure	the patients under go the open esophagogastric devascularization and splenectomy

Primary Outcome Measures

Name	Time	Method
recurrence	5 years	gastroesophageal varices recurrence rate

Secondary Outcome Measures

Name	Time	Method
operation time	1 day	Duration of surgical procedure

Trial Locations

Locations (1)

Department of General Surgery , Second Affiliated Hospita l, Xi'an Jiaotong Universi ty School of Medicine; 🇨🇳 Xi'an, China