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

Study Overview
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Brief Summary
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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.

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

Conditions
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Portal Hypertension, Liver Cirrhosis

Intervention / Treatment
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* Procedure: open surgical procedure
* Procedure: laparoscopic surgical procedure


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: open group<br>the patients under go the open esophagogastric devascularization and splenectomy | Procedure: open surgical procedure<br>* open esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients<br>|
| Experimental: laparoscopic group<br>the patients under go the laparoscopic esophagogastric devascularization and splenectomy | Procedure: laparoscopic surgical procedure<br>* laparoscopic esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence | gastroesophageal varices recurrence rate | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time | Duration of surgical procedure | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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portal hypertension, Randomized clinical trial, laparoscopic, open