Portal HypertensionNCT02178319
Laparoscopic Versus Open Devascularization for Portal Hypertension, a Randomized Controlled Trial
A study testing open surgical procedure and laparoscopic surgical procedure in people with Portal Hypertension and Liver Cirrhosis, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Portal Hypertension, Liver Cirrhosis
- What is being tested?
- open surgical procedure and laparoscopic surgical procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Sep 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The cause of portal hypertension was cirrhosis
- Platelet count < 50×109/ml
- Esophageal and gastric varices revealed
- Agreeing the informed consent.
Who cannot join
- Thrombosis present in portal vein preoperatively
- Accompany with liver cancer
- Operation procedure is laparoscopy converse to open
- Patients disagree with the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery , Second Affiliated Hospita l, Xi'an Jiaotong Universi ty School of Medicine
Xi'an, 710004
Yang Liu, Doctor, +86-29-87679246, individualliu@163.com
About this study
Official title: Randomized Clinical Trial Comparing Laparoscopic and Open Esophagogastric Devascularization and Splenectomy for Portal Hypertension
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.
- Conditions
- Portal Hypertension, Liver Cirrhosis
- Being tested
- open surgical procedure, laparoscopic surgical procedure
- Keywords
- portal hypertension, Randomized clinical trial, laparoscopic, open
- Medical subject headings
- Hypertension, Portal, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open surgical procedureProcedure or surgery
open esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients
laparoscopic surgical procedureProcedure or surgery
laparoscopic esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients
| Study group | Role | What they receive |
|---|---|---|
| open group | Active comparator | the patients under go the open esophagogastric devascularization and splenectomy Receives: Procedure: open surgical procedure |
| laparoscopic group | Experimental | the patients under go the laparoscopic esophagogastric devascularization and splenectomy Receives: Procedure: laparoscopic surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
gastroesophageal varices recurrence rate
Measured: 5 years
Secondary outcomes (1)
operation time
Duration of surgical procedure
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178319
- Sponsor's protocol ID
- portal hypertension
- Status last verified
- Jun 2014
- First submitted
- 19 Jun 2014
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Laparoscopic and Open Esophagogastric Devascularization and Splenectomy for Portal Hypertension
- ClinicalTrials.gov ID
- NCT02178319
- Acronym / sponsor ID
- portal hypertension
- Conditions
- Portal Hypertension, Liver Cirrhosis
- Keywords
- portal hypertension, Randomized clinical trial, laparoscopic, open
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 30 Jun 2014 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open group | Active comparator | Procedure: open surgical procedurethe patients under go the open esophagogastric devascularization and splenectomy |
| laparoscopic group | Experimental | Procedure: laparoscopic surgical procedurethe patients under go the laparoscopic esophagogastric devascularization and splenectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The cause of portal hypertension was cirrhosis
- Platelet count < 50×109/ml
- Esophageal and gastric varices revealed
- Agreeing the informed consent.
Key exclusion criteria (4 listed)
- Thrombosis present in portal vein preoperatively
- Accompany with liver cancer
- Operation procedure is laparoscopy converse to open
- Patients disagree with the study.
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 |
|---|---|---|
| open surgical procedureopen esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients | Procedure or surgery | open group |
| laparoscopic surgical procedurelaparoscopic esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients | Procedure or surgery | laparoscopic group |
Primary outcome
recurrence
Time frame: 5 years
gastroesophageal varices recurrence rate
1 secondary outcome
operation time
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open surgical procedure and laparoscopic surgical procedure in people with Portal Hypertension and Liver Cirrhosis, run by Second Affiliated Hospital of Xi'an Jiaotong University 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 4 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: status not confirmed, as of the sponsor's last update on 30 Jun 2014. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Liu, Doctor (+86-29-87679246, individualliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence (time frame: 5 years). 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 30 Jun 2014.