A Clinical Trial of the Vessel Sealing System (LigaSure) in Azygoportal Disconnection and Splenectomy in Patients With Portal Hypertension
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this trial was to verify the efficiency of a new surgical device (the LigaSure
      vessels sealing system) in esophagogastric decongestion and splenectomy in patients with
      portal hypertension.
    

Detailed description: 
      Bleeding from esophageal and gastric cardia varices is the major life threatening
      complication in patients with portal hypertension. Patients with portal hypertension have a
      mortality rate of 30%-50% at the first episode of esophagogastric variceal rupture. The
      associated 1-year mortality rate is reported to be 75%. The ideal treatment for gastric
      varices should effectively control bleeding and improve the liver function to optimum levels.
      Although endoscopic treatments have showed great promise for esophageal varices, there is
      still controversy regarding the treatment of gastric varices. Hepatic encephalopathy remain a
      dominant problems after transjugular intrahepatic portosystemic shunt placement (TIPS) and
      surgical shunts. A meta-analysis has shown that the incidence of hepatic encephalopathy and
      mortality was increased significantly either in nonselective or selective shunt operations.

      Esophagogastric decongestion and splenectomy with or without esophageal transaction were the
      fundamental operation performed in our department for patients with portal hypertension.
      Patients under the azygoportal devascularization methods revealed reduction of the
      encephalopathy as well as diminished rebleeding rates. The crucial point of the procedure is
      prevention of the brisk bleeding from the dilated vessels like enlarged azygoportal
      collaterals. Conventional hand-tied ligatures can become dislodged and represent a foreign
      body, and more important, it is tedious and time-consuming. The LigaSure vessel sealing
      system (Valleylab, Boulder, Colorado) is a bipolar electrosurgical device, sealing vessels up
      to 7 mm in diameter, by denaturing collagen and elastin within vessel wall and surrounding
      connective tissue. This device was tested, with excellent results, in different fields of
      surgery (gastrointestinal, hepatopancreatobiliary, urologic, gynecologic, laparoscopic, etc),
      as demonstrated by several recently published studies. Shamiyeh et al confirmed the
      reliability of LigaSure for the closure of the veins in laparoscopic azygoportal
      disconnection procedure on the portal hypertension porcine model in 2005, there was no intra-
      or post-operative bleeding and no conversion to open surgery, and when more than 2 mm far
      from the thermal energy source, no collateral damage of the solid tissue such as stomach
      could be detected.
    

Intervention name(s): Vessel sealing system LigaSure
Intervention type(s): Device
Intervention description(s): Patients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ligasure vessel sealing system; Azygoportal Disconnection; Splenectomy; Portal hypertension