Portal Vein, Cavernous Transformation OfNCT02505113
Cavernous Transformation of Portal Vein： Etiology, Diagnosis, Management and Prognosis
An observational study of Portal Vein, Cavernous Transformation Of, run by Sun Yat-sen University at 1 site in China.
Trial summary
To observe the etiology, diagnosis, management and prognosis of cavernous transformation of portal vein. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Portal Vein, Cavernous Transformation Of
- What is being tested?
- Montelukast
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Dec 2020
- Phase
- Observational
- 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 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with CTPV
Who may be able to join
- All patients with CTPV.
Who cannot join
- Patients with known severe dysfunction of heart, lung, brain, kidney and other vital organs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Radiology
Guangzhou, Guangdong, 510630
Zaibo Jiang, MD., +86 020 85253416, jiangzaibo@aliyun.com
About this study
To observe the etiology, diagnosis, management and prognosis of cavernous transformation of portal vein.
Read the detailed description
To observe the etiology, diagnosis, management and prognosis of cavernous transformation of portal vein.
We perform Montelukast (10mg, q.d., p.o.) fot the treatment of symptomatic cavernous transformation of portal vein and to observe the efficacy such as the decrease of the volume of ascites and hydrothorax.
- Conditions
- Portal Vein, Cavernous Transformation Of
- Being tested
- Montelukast
- Keywords
- Portal Vein, Cavernous Transformation Of, Hypertension, Portal
- Medical subject headings
- Portal Vein, Cavernous Transformation Of, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Montelukast (10mg, q.d., p.o.)
| Study group | Role | What they receive |
|---|---|---|
| CTPV without Montelukast | Patients with CTPV do not receive the treatment of Montelukast. | |
| CTPV treated with Montelukast | Patients with CTPV treated with Montelukast (10mg, q.d., p.o.). Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ascites Volume (mL)
Ascites measured by CT scanning or ultrasound (If the patients had the history of ascites before)
Measured: 6 month
Hydrothorax Volume (mL)
Hydrothorax measured by CT scanning or ultrasound (If the patients had the history of hydrothorax before)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startOct 2010
- Primary completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Vein, Cavernous Transformation OfStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaibo Jiang, Sun Yat-sen University
- Investigators
- Zaibo Jiang, MD, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505113
- Sponsor's protocol ID
- CTPVDORNO3HSYSU
- Status last verified
- Oct 2015
- First submitted
- 16 Jul 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cavernous Transformation of Portal Vein： Etiology, Diagnosis, Management and Prognosis
- ClinicalTrials.gov ID
- NCT02505113
- Acronym / sponsor ID
- CTPVDORNO3HSYSU
- Conditions
- Portal Vein, Cavernous Transformation Of
- Keywords
- Portal Vein, Cavernous Transformation Of, Hypertension, Portal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2020 (estimated)
- First posted
- 22 Jul 2015 (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.
To observe the etiology, diagnosis, management and prognosis of cavernous transformation of portal vein.
Detailed description
To observe the etiology, diagnosis, management and prognosis of cavernous transformation of portal vein.
We perform Montelukast (10mg, q.d., p.o.) fot the treatment of symptomatic cavernous transformation of portal vein and to observe the efficacy such as the decrease of the volume of ascites and hydrothorax.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTPV without Montelukast | – | –Patients with CTPV do not receive the treatment of Montelukast. |
| CTPV treated with Montelukast | – | Drug: MontelukastPatients with CTPV treated with Montelukast (10mg, q.d., p.o.). |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with CTPV
Key inclusion criteria (1 listed)
- All patients with CTPV.
Key exclusion criteria (1 listed)
- Patients with known severe dysfunction of heart, lung, brain, kidney and other vital organs.
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 |
|---|---|---|
| MontelukastMontelukast (10mg, q.d., p.o.) | Drug | CTPV treated with Montelukast |
Primary outcome
Ascites Volume (mL)
Time frame: 6 month
Ascites measured by CT scanning or ultrasound (If the patients had the history of ascites before)
Hydrothorax Volume (mL)
Time frame: 6 month
Hydrothorax measured by CT scanning or ultrasound (If the patients had the history of hydrothorax before)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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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.
Zaibo Jiang, MD study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Vein, Cavernous Transformation Of, run by Sun Yat-sen 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 1 inclusion and 1 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 29 Oct 2015. 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 Zaibo Jiang, MD (+86 020 85253416, jiangzaibo@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ascites Volume (mL) (time frame: 6 month). The study lists 2 primary outcomes in all. 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 29 Oct 2015; AzTrials last refreshed its copy on 8 Nov 2026.