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A Clinical Trial of the Vessel Sealing System (LigaSure) in Azygoportal Disconnection and Splenectomy in Patients With Portal Hypertension

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Vessel sealing system LigaSure
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Ligasure vessel sealing system, Azygoportal Disconnection, Splenectomy, Portal hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of General Surgery, Shanghai Chang Zheng Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vessel sealing system LigaSure (VS group)

Conventional hand-tied method (CH group)

Arm Description

Patients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure.

Patients in CH group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the conventional hand-tied method.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postoperative drainage volume, complications (spleen fever, bleeding and portal vein thrombosis), length of incision, postoperative pain and time to discharge.

Full Information

First Posted
August 25, 2009
Last Updated
August 26, 2009
Sponsor
Shanghai Changzheng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00965744
Brief Title
A Clinical Trial of the Vessel Sealing System (LigaSure) in Azygoportal Disconnection and Splenectomy in Patients With Portal Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Changzheng Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Ligasure vessel sealing system, Azygoportal Disconnection, Splenectomy, Portal hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vessel sealing system LigaSure (VS group)
Arm Type
Experimental
Arm Description
Patients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure.
Arm Title
Conventional hand-tied method (CH group)
Arm Type
No Intervention
Arm Description
Patients in CH group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the conventional hand-tied method.
Intervention Type
Device
Intervention Name(s)
Vessel sealing system LigaSure
Intervention Description
Patients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure.
Primary Outcome Measure Information:
Title
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.
Time Frame
Within the operation
Secondary Outcome Measure Information:
Title
Postoperative drainage volume, complications (spleen fever, bleeding and portal vein thrombosis), length of incision, postoperative pain and time to discharge.
Time Frame
within the first 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Wang, MD
Organizational Affiliation
Shanghai Chang Zheng Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jia Dong Gao, MD
Organizational Affiliation
Department of General Surgery, Shanghai Chang Zheng Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Jun Wang, MD
Organizational Affiliation
Department of General Surgery, Shanghai Chang Zheng Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hou Shan Yao, MD
Organizational Affiliation
Department of General Surgery, Shanghai Chang Zheng Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhi Qian Hu, MD
Organizational Affiliation
Department of General Surgery, Shanghai Chang Zheng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General Surgery, Shanghai Chang Zheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial of the Vessel Sealing System (LigaSure) in Azygoportal Disconnection and Splenectomy in Patients With Portal Hypertension

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