Portal Vein, Cavernous Transformation ofPhase 3NCT02853526
TIPS for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis and CTPV
A Phase 3 study testing TIPS, Propranolol and Endoscopic therapy in people with Portal Vein, Cavernous Transformation of and Portal Vein Thrombosis, run by Zaibo Jiang at 1 site in China.
Trial summary
To date, there is no treatment strategies for these patients according to American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus. Thus, we aim to compare the safety and efficacy of TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or… Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Portal Vein, Cavernous Transformation of, Portal Vein Thrombosis, Liver Cirrhosis
- What is being tested?
- TIPS, Propranolol and Endoscopic therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Dec 2018
- Phase
- Phase 3
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients diagnosis with portal vein thrombosis and cavernous transformation of portal vein and portal hypertension by contrast enhanced CT or MRI.
- History of variceal bleeding.
- Liver cirrhosis.
- Neutrophilous counts≥ 1.5×109/L, Platelet counts ≥ 50 × 109/L, Hemoglobin≥ 85g/L.
- Albumin ≥2.8 g/dL, total bilirubin <51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）<5 times of upper limit.
- PT(Prothrombin time)-INR(international normalized ratio) < 1.7.
Who cannot join
- Thrombosis involve superior mesenteric vein, splenic vein, or the whole portal vein system. Not suitable for TIPS (judged by principal investigator).
- Company with malignant tumors in liver or other organs.
- Patients with known severe dysfunction of heart, lung, brain or kidney.
- Active bleeding.
- Not eligible for anticoagulation therapy,non-selective beta blockers or endoscopic therapy.
- Uncontrolled infection.
- Pregnancy and breastfeeding.
- HIV infection.
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
Official title: Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis (PVT) and Cavernous Transformation of the Portal Vein (CTPV)
To date, there is no treatment strategies for these patients according to American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus. Thus, we aim to compare the safety and efficacy of TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV.
Read the detailed description
The incidence of portal vein thrombosis (PVT) is about 16% in cirrhotic patients. Chronic PVT often cause two main undesirable consequences: symptomatic portal hypertension (such as variceal bleeding or ascites) and cavernous transformation of portal vein (CPTV). The former could lead to death and the latter increases the difficulty of the transjugular intrahepatic portosystemic shunt (TIPS) treatment, which is considered as a main effective treatment for symptomatic portal hypertension. Some patients with CPTV and variceal bleeding only have to receive conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation). With advances in technology, modified TIPS procedure could significantly improve the operation success rate of patients with CPTV. To date, the difference in safety and efficacy between TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV is still unclear.
- Conditions
- Portal Vein, Cavernous Transformation of, Portal Vein Thrombosis, Liver Cirrhosis, Bleeding Esophageal Varices
- Being tested
- TIPS, Propranolol, Endoscopic therapy, Warfarin
- Medical subject headings
- Portal Vein, Cavernous Transformation Of, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPSProcedure or surgery
Also called Transjugular intrahepatic portosystemic shunt
Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach (p-TIPS). Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal for the prevention of shunt dysfunction.
PropranololDrug
Propranolol is a kind of non-selective beta blockers, and is used for reducing the portal pressure.
Endoscopic therapyProcedure or surgery
Endoscopic therapy includes the endoscopic variceal band ligation and sclerotherapy.
WarfarinDrug
Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal.
| Study group | Role | What they receive |
|---|---|---|
| TIPS arm | Experimental | Transjugular intrahepatic portosystemic shunt(TIPS) is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein. It is used to treat portal hypertension.TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach (also called p-TIPS or modified TIPS). Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal for the prevention of shunt dysfunction. Receives: Procedure: TIPS; Drug: Warfarin |
| conservative treatment arm | Active comparator | Conservative treatment including endoscopic therapy，non-selective beta blockers (propranolol)and anticoagulation therapy (warfarin). Receives: Drug: Propranolol; Procedure: Endoscopic therapy; Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variceal rebleeding
Variceal rebleeding rate in 3 years
Measured: 3 years
Secondary outcomes (4)
Overall survival time
Measured: 3 years
Variceal rebleeding-related death rate
Measured: 3 years
Treatment-related complications
Incidence of treatment-related complications
Measured: 3 years
Transjugular intrahepatic portosystemic shunt success rate
Technical success rate of transjugular intrahepatic portosystemic shunt
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zaibo Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zaibo Jiang, Sun Yat-sen University
- Investigators
- Zaibo Jiang, Principal investigator, Department of Intervention and Vascular Surgery, the Third Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853526
- Sponsor's protocol ID
- TIPSVRDORNO3HSYSU
- Status last verified
- Jul 2016
- First submitted
- 24 Jul 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis (PVT) and Cavernous Transformation of the Portal Vein (CTPV)
- ClinicalTrials.gov ID
- NCT02853526
- Acronym / sponsor ID
- TIPSVRDORNO3HSYSU
- Conditions
- Portal Vein, Cavernous Transformation of, Portal Vein Thrombosis, Liver Cirrhosis, Bleeding Esophageal Varices
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zaibo JiangUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 3 Aug 2016 (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 date, there is no treatment strategies for these patients according to American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus. Thus, we aim to compare the safety and efficacy of TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV.
Detailed description
The incidence of portal vein thrombosis (PVT) is about 16% in cirrhotic patients. Chronic PVT often cause two main undesirable consequences: symptomatic portal hypertension (such as variceal bleeding or ascites) and cavernous transformation of portal vein (CPTV). The former could lead to death and the latter increases the difficulty of the transjugular intrahepatic portosystemic shunt (TIPS) treatment, which is considered as a main effective treatment for symptomatic portal hypertension. Some patients with CPTV and variceal bleeding only have to receive conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation). With advances in technology, modified TIPS procedure could significantly improve the operation success rate of patients with CPTV. To date, the difference in safety and efficacy between TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV is still unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPS arm | Experimental | Procedure: TIPS, Drug: WarfarinTransjugular intrahepatic portosystemic shunt(TIPS) is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein. It is used to treat portal hypertension.TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach (also called p-TIPS or modified TIPS). Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal for the prevention of shunt dysfunction. |
| conservative treatment arm | Active comparator | Drug: Propranolol, Procedure: Endoscopic therapy, Drug: WarfarinConservative treatment including endoscopic therapy，non-selective beta blockers (propranolol)and anticoagulation therapy (warfarin). |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- All patients diagnosis with portal vein thrombosis and cavernous transformation of portal vein and portal hypertension by contrast enhanced CT or MRI.
- History of variceal bleeding.
- Liver cirrhosis.
- Neutrophilous counts≥ 1.5×109/L, Platelet counts ≥ 50 × 109/L, Hemoglobin≥ 85g/L.
- Albumin ≥2.8 g/dL, total bilirubin <51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）<5 times of upper limit.
Key exclusion criteria (8 listed)
- Thrombosis involve superior mesenteric vein, splenic vein, or the whole portal vein system. Not suitable for TIPS (judged by principal investigator).
- Company with malignant tumors in liver or other organs.
- Patients with known severe dysfunction of heart, lung, brain or kidney.
- Active bleeding.
- Not eligible for anticoagulation therapy,non-selective beta blockers or endoscopic therapy.
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 |
|---|---|---|
| TIPSAlso: Transjugular intrahepatic portosystemic shuntTransjugular intrahepatic portosystemic shunt(TIPS)- TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach (p-TIPS). Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal for the prevention of shunt dysfunction. | Procedure or surgery | TIPS arm |
| PropranololPropranolol is a kind of non-selective beta blockers, and is used for reducing the portal pressure. | Drug | conservative treatment arm |
| Endoscopic therapyEndoscopic therapy includes the endoscopic variceal band ligation and sclerotherapy. | Procedure or surgery | conservative treatment arm |
| WarfarinOral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal. | Drug | TIPS arm, conservative treatment arm |
Primary outcome
Variceal rebleeding
Time frame: 3 years
Variceal rebleeding rate in 3 years
4 secondary outcomes
Overall survival time
Time frame: 3 years
Variceal rebleeding-related death rate
Time frame: 3 years
Treatment-related complications
Time frame: 3 years
Transjugular intrahepatic portosystemic shunt success rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Portal Vein, Cavernous Transformation of
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Not yet recruiting
Mesenteric Vein Access for OPVT-Related Recurrent Variceal Bleeding: An Ambispective Cohort
Occlusive Portal Vein Thrombosis (OPVT), Cavernous Transformation of Portal Vein
Recruiting
Efficacy and Safety of Variceal Embolization Combined With Partial Splenic Artery Embolization for Variceal Bleeding in Cavernous Transformation of Portal Vein.
Cavernous Transformation of Portal Vein, Gastroesophageal Varices Bleeding
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 principal investigator
Department of Intervention and Vascular Surgery, the Third Affiliated Hospital, 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 Phase 3 study testing TIPS, Propranolol and Endoscopic therapy in people with Portal Vein, Cavernous Transformation of and Portal Vein Thrombosis, run by Zaibo Jiang 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 6 inclusion and 8 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 3 Aug 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tao Pan (8602085252066, pant5@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variceal rebleeding (time frame: 3 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 3 Aug 2016.