Liver CirrhosisPhase 4NCT00965744
A Clinical Trial of the Vessel Sealing System (LigaSure) in Azygoportal Disconnection and Splenectomy in Patients With Portal Hypertension
A Phase 4 study testing Vessel sealing system LigaSure in people with Liver Cirrhosis, run by Shanghai Changzheng Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Vessel sealing system LigaSure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2006to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Liver function as Child-Pugh C
- Hemoglobin < 9 g/dL
- Ascites
- Abnormal coagulation
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery, Shanghai Chang Zheng Hospital
Shanghai, Shanghai Municipality, 200003
About this study
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.
Read the 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.
- Conditions
- Liver Cirrhosis
- Being tested
- Vessel sealing system LigaSure
- Keywords
- Ligasure vessel sealing system, Azygoportal Disconnection, Splenectomy, Portal hypertension
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vessel sealing system LigaSureDevice
Patients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure.
| Study group | Role | What they receive |
|---|---|---|
| Vessel sealing system LigaSure (VS group) | Experimental | Patients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure. Receives: Device: Vessel sealing system LigaSure |
| Conventional hand-tied method (CH group) | No intervention | Patients in CH group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the conventional hand-tied method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the operation
Secondary outcomes (1)
Postoperative drainage volume, complications (spleen fever, bleeding and portal vein thrombosis), length of incision, postoperative pain and time to discharge.
Measured: within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startJan 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Qiang Wang, MD, Study chair, Shanghai Chang Zheng HospitalJia Dong Gao, MD, Principal investigator, Department of General Surgery, Shanghai Chang Zheng HospitalWei Jun Wang, MD, Principal investigator, Department of General Surgery, Shanghai Chang Zheng HospitalHou Shan Yao, MD, Principal investigator, Department of General Surgery, Shanghai Chang Zheng HospitalZhi Qian Hu, MD, Principal investigator, Department of General Surgery, Shanghai Chang Zheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965744
- Sponsor's protocol ID
- SCZH-0908-016
- Status last verified
- Aug 2009
- First submitted
- 25 Aug 2009
- Last updated
- 27 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of the Vessel Sealing System (LigaSure) in Azygoportal Disconnection and Splenectomy in Patients With Portal Hypertension
- ClinicalTrials.gov ID
- NCT00965744
- Acronym / sponsor ID
- SCZH-0908-016
- Conditions
- Liver Cirrhosis
- Keywords
- Ligasure vessel sealing system, Azygoportal Disconnection, Splenectomy, Portal hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 26 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vessel sealing system LigaSure (VS group) | Experimental | Device: Vessel sealing system LigaSurePatients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure. |
| Conventional hand-tied method (CH group) | No intervention | –Patients in CH group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the conventional hand-tied method. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- Liver function as Child-Pugh C
- Hemoglobin < 9 g/dL
- Ascites
- Abnormal coagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vessel sealing system LigaSurePatients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure. | Device | Vessel sealing system LigaSure (VS group) |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiang Wang, MD study chair
Shanghai Chang Zheng Hospital
Jia Dong Gao, MD principal investigator
Department of General Surgery, Shanghai Chang Zheng Hospital
Wei Jun Wang, MD principal investigator
Department of General Surgery, Shanghai Chang Zheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vessel sealing system LigaSure in people with Liver Cirrhosis, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Within the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2009.