Portal Vein, Cavernous Transformation OfNCT02504034
Interventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein
A study testing Transhepatic portosystemic shunt, 6-French sheath and 22-gauge chiba needle in people with Portal Vein, Cavernous Transformation Of and Hypertension, Portal, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate the values of portosystemic shunt and other interventional radiology approaches for treatment of symptomatic portal hypertension in patients with 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, Hypertension, Portal
- What is being tested?
- Transhepatic portosystemic shunt, 6-French sheath and 22-gauge chiba needle
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Dec 2020
- 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 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with portal hypertention who have enough image information to confirm cavernous transformation 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 portosystemic shunt and other interventional radiology approaches for treatment of symptomatic portal hypertension in patients with cavernous transformation of portal vein.
- Being tested
- Transhepatic portosystemic shunt, 6-French sheath, 22-gauge chiba needle, 260-cm-long stiff shaft wire, Balloon catheter
- Keywords
- Portal Vein, Cavernous Transformation Of, Hypertension, Portal, Radiology, Interventional, Portalsystemic shunt
- 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.
Transhepatic portosystemic shuntProcedure or surgery
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 6-French sheath inserted over the wire. Then middle hepatic vein (MHV) was punctured with a 20-gauge reformed needle through the transhepatic 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-long stiff shaft wire was introduced through the transjugular sheath and manipulated into main portal vein (MPV) and then into SMV. The parenchymal tract was dilated with balloon catheter, then one or more bare metal stents and one or more covered stents were inserted to line the parenchymal tract.
6-French sheathDevice
22-gauge chiba needleDevice
260-cm-long stiff shaft wireDevice
Balloon catheterDevice
Bare metal stentDevice
Covered stentDevice
| Study group | Role | What they receive |
|---|---|---|
| Transhepatic portosystemic shunt | Experimental | Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment Receives: Procedure: Transhepatic portosystemic shunt; Device: 6-French sheath; Device: 22-gauge chiba needle; Device: 260-cm-long stiff shaft wire; Device: Balloon catheter; Device: Bare metal stent; Device: Covered stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Gastrointestinal Bleeding
No gastrointestinal bleeding proved by patients' symptoms (If the patients had the history of gastrointestinal bleeding before)
Measured: 1 month
Ascites Volume (mL)
No ascites proved by CT scanning or ultrasound (If the patients had the history of ascites before)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT02504034
- Sponsor's protocol ID
- DORNO3HSYSU
- Status last verified
- Jul 2015
- First submitted
- 15 Jul 2015
- Last updated
- 21 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein
- ClinicalTrials.gov ID
- NCT02504034
- Acronym / sponsor ID
- DORNO3HSYSU
- Keywords
- Portal Vein, Cavernous Transformation Of, Hypertension, Portal, Radiology, Interventional, Portalsystemic shunt
- Study type
- Interventional
- 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
- 21 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 portosystemic shunt and other interventional radiology approaches for treatment of symptomatic portal hypertension in patients with cavernous transformation of portal vein.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transhepatic portosystemic shunt | Experimental | Procedure: Transhepatic portosystemic shunt, Device: 6-French sheath, Device: 22-gauge chiba needle, Device: 260-cm-long stiff shaft wire, Device: Balloon catheter, Device: Bare metal stent, Device: Covered stentPatients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with portal hypertention who have enough image information to confirm cavernous transformation 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 |
|---|---|---|
| Transhepatic portosystemic shuntPortal 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 6-French sheath inserted over the wire. Then middle hepatic vein (MHV) was punctured with a 20-gauge reformed needle through the transhepatic 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-long stiff shaft wire was introduced through the transjugular sheath and manipulated into main portal vein (MPV) and then into SMV. The parenchymal tract was dilated with balloon catheter, then one or more bare metal stents and one or more covered stents were inserted to line the parenchymal tract. | Procedure or surgery | Transhepatic portosystemic shunt |
| 6-French sheath | Device | Transhepatic portosystemic shunt |
| 22-gauge chiba needle | Device | Transhepatic portosystemic shunt |
| 260-cm-long stiff shaft wire | Device | Transhepatic portosystemic shunt |
| Balloon catheter | Device | Transhepatic portosystemic shunt |
| Bare metal stent | Device | Transhepatic portosystemic shunt |
| Covered stent | Device | Transhepatic portosystemic shunt |
Primary outcome
Incidence Rate of Gastrointestinal Bleeding
Time frame: 1 month
No gastrointestinal bleeding proved by patients' symptoms (If the patients had the history of gastrointestinal bleeding before)
Ascites Volume (mL)
Time frame: 1 month
No ascites proved by CT scanning or ultrasound (If the patients had the history of ascites before)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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 Transhepatic portosystemic shunt, 6-French sheath and 22-gauge chiba needle in people with Portal Vein, Cavernous Transformation Of and Hypertension, Portal, 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 21 Jul 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?
Incidence Rate of Gastrointestinal Bleeding (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 21 Jul 2015.