Clinical trial NCT00965744: A Clinical Trial of the Vessel Sealing System (LigaSure) in Azygoportal Disconnection and Splenectomy in Patients With Portal Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Cirrhosis
Keywords: Ligasure vessel sealing system
Azygoportal Disconnection
Splenectomy
Portal hypertension
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2009-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients with liver cirrhosis accompanied by portal hypertension and secondary hypersplenism due to hepatitis, alcoholic cirrhosis or schistosomiasis, who undergoing elective azygoportal disconnection and splenectomy

Exclusion Criteria:

* Liver function as Child-Pugh C
* Hemoglobin \< 9 g/dL
* Ascites
* Abnormal coagulation

Primary outcomes:
measure: Operating time, from the skin incision to the final skin closure. Intraoperative blood loss, calculated by a graduated suction device and by amounts of blood involved into the sponges by the end of the operation.
timeFrame: Within the operation
Secondary outcomes:
measure: Postoperative drainage volume, complications (spleen fever, bleeding and portal vein thrombosis), length of incision, postoperative pain and time to discharge.
timeFrame: within the first 30 days after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of General Surgery, Shanghai Chang Zheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chang Zheng Hospital
name: Qiang Wang, MD
role: STUDY_CHAIR
affiliation: Department of General Surgery, Shanghai Chang Zheng Hospital
name: Jia Dong Gao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of General Surgery, Shanghai Chang Zheng Hospital
name: Wei Jun Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of General Surgery, Shanghai Chang Zheng Hospital
name: Hou Shan Yao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of General Surgery, Shanghai Chang Zheng Hospital
name: Zhi Qian Hu, MD
role: PRINCIPAL_INVESTIGATOR
References: