Hypertension, PortalNCT02505152
Percutaneous Transhepatic Intrahepatic Portosystemic Shunt for Treatment of Portal Vein Occlusion With Symptomatic Portal Hypertension After Splenectomy
A study testing Percutaneous transhepatic intrahepatic portosystemic shunt in people with Hypertension, Portal and Portal Vein, Cavernous Transformation Of, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate the values of percutaneous transhepatic intrahepatic portosystemic shunt for treatment of portal vein occlusion with symptomatic portal hypertension after splenectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension, Portal, Portal Vein, Cavernous Transformation Of
- What is being tested?
- Percutaneous transhepatic intrahepatic portosystemic shunt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Dec 2016
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with portal hypertension who have the history of splenectomy and have enough image information to confirm occlusion of portal vein
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, 510000
Zaibo Jiang, MD., +86 020 85252066, jiangzaibo@aliyun.com
About this study
To evaluate the values of percutaneous transhepatic intrahepatic portosystemic shunt for treatment of portal vein occlusion with symptomatic portal hypertension after splenectomy.
- Being tested
- Percutaneous transhepatic intrahepatic portosystemic shunt
- Keywords
- Hypertension, Portal, Portal Vein, Cavernous Transformation Of, Portosystemic shunt, Radiology, Interventional
- Medical subject headings
- Hypertension, Portal, Portal Vein, Cavernous Transformation Of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous transhepatic intrahepatic portosystemic shuntProcedure or surgery
Under fluoroscopic guidance, portal vein(PV) was punctured with a 22-gauge Chiba needle. A 0.018-inch guidewire was advanced through the needle into PV lumen. The needle was exchanged and a 7-French sheath inserted over the wire. Then retrohepatic inferior vena cava(RIVC) or hepatic vein(HV) was punctured with a 20-gauge, 30-cm Chiba needle through sheath. Another 0.018-inch guidewire was advanced through the needle into right internal jugular vein and then snared out of body. A 0.035-inch, 260-cm stiff shaft wire was then introduced through the transjugular sheath and manipulated into main portal vein(MPV) and then into superior mesenteric vein(SMV). Afterward the PTIPS procedure was completed in the standard transjugular fashion.
| Study group | Role | What they receive |
|---|---|---|
| Shunt | Experimental | Perform percutaneous transhepatic intrahepatic portosystemic shunt Receives: Procedure: Percutaneous transhepatic intrahepatic portosystemic shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
No gastrointestinal rebleeding in 1 month after interventions
No gastrointestinal rebleeding in 1 month after interventions
Measured: 1 month
Ascites disappear in 1 month after interventions
Ascites disappear in 1 month after interventions
Measured: 1 month
Secondary outcomes (1)
Whether the shunt is patent after interventions in 6 months
Patent shunt in 6 months after interventions proved by US or CT
Measured: 6 months
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 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PortalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT02505152
- Sponsor's protocol ID
- PTIPSDORNO3HSYSU
- Status last verified
- Nov 2015
- First submitted
- 16 Jul 2015
- Last updated
- 11 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Transhepatic Intrahepatic Portosystemic Shunt for Treatment of Portal Vein Occlusion With Symptomatic Portal Hypertension After Splenectomy
- ClinicalTrials.gov ID
- NCT02505152
- Acronym / sponsor ID
- PTIPSDORNO3HSYSU
- Keywords
- Hypertension, Portal, Portal Vein, Cavernous Transformation Of, Portosystemic shunt, Radiology, Interventional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2016 (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 evaluate the values of percutaneous transhepatic intrahepatic portosystemic shunt for treatment of portal vein occlusion with symptomatic portal hypertension after splenectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shunt | Experimental | Procedure: Percutaneous transhepatic intrahepatic portosystemic shuntPerform percutaneous transhepatic intrahepatic portosystemic shunt |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with portal hypertension who have the history of splenectomy and have enough image information to confirm occlusion of portal vein
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 |
|---|---|---|
| Percutaneous transhepatic intrahepatic portosystemic shuntUnder fluoroscopic guidance, portal vein(PV) was punctured with a 22-gauge Chiba needle. A 0.018-inch guidewire was advanced through the needle into PV lumen. The needle was exchanged and a 7-French sheath inserted over the wire. Then retrohepatic inferior vena cava(RIVC) or hepatic vein(HV) was punctured with a 20-gauge, 30-cm Chiba needle through sheath. Another 0.018-inch guidewire was advanced through the needle into right internal jugular vein and then snared out of body. A 0.035-inch, 260-cm stiff shaft wire was then introduced through the transjugular sheath and manipulated into main portal vein(MPV) and then into superior mesenteric vein(SMV). Afterward the PTIPS procedure was completed in the standard transjugular fashion. | Procedure or surgery | Shunt |
Primary outcome
No gastrointestinal rebleeding in 1 month after interventions
Time frame: 1 month
No gastrointestinal rebleeding in 1 month after interventions
Ascites disappear in 1 month after interventions
Time frame: 1 month
Ascites disappear in 1 month after interventions
1 secondary outcome
Whether the shunt is patent after interventions in 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 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?
A study testing Percutaneous transhepatic intrahepatic portosystemic shunt in people with Hypertension, Portal and 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 11 Nov 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 85252066, jiangzaibo@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No gastrointestinal rebleeding in 1 month after interventions (time frame: 1 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 11 Nov 2015.