Portal Hypertension Related to CirrhosisNCT06589531
Small Diameter TIPS in Patients with Severe Liver Atrophy and Variceal Bleeding
A study testing During TIPS operation, shunt diameter or diameter of covered stent in people with Portal Hypertension Related to Cirrhosis, run by Huang Mingsheng.
Trial summary
Portal hypertension is the most common complication in patients with end-stage liver cirrhosis. Portal hypertension-related complications, such as variceal bleeding, often lead to a poor prognosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Portal Hypertension Related to Cirrhosis
- What is being tested?
- During TIPS operation, shunt diameter or diameter of covered stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 15 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as cirrhosis
- Previous or present endoscopic diagnosis of esophageal and gastric varices bleeding.
- Child -Pugh score C (≤13) or MELD≤18.
- Enhanced image measurement of liver volume ≤1000cm3.
- Have indications for TIPS treatment.
- Researchers believe that patients have the ability to comply with the research plan.
- Sign the informed consent form
Who cannot join
- Malignant tumor (including hepatocellular carcinoma) or other diseases that will shorten the life span of patients.
- Cavernous portal vein
- Non-cirrhotic portal hypertension (Budd-Chiari syndrome, extrahepatic portal vein obstruction, idiopathic portal hypertension, etc.)
- Spontaneous dominant hepatic encephalopathy 5 congestive heart failure or severe valvular heart failure
- 6. Uncontrollable systemic infection or inflammation 7. Severe pulmonary hypertension 8. Severe renal insufficiency (except hepatogenic renal insufficiency) 9. Rapidly progressing liver failure 10. Contrast agent allergy 11. History of liver transplantation or allogeneic organ transplantation 12. Have a history of TIPS or shunt operation. 13. Pregnancy or lactation 14. Poor compliance 15. Participate in another clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 6 Mm Shunt Transjugular Intrahepatic Portosystemic Shunt in Patients with Severe Liver Atrophy and Variceal Bleeding:A Prospective Single-center Randomized Controlled Study
Portal hypertension is the most common complication in patients with end-stage liver cirrhosis. Portal hypertension-related complications, such as variceal bleeding, often lead to a poor prognosis. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective treatment strategy for managing portal hypertension-related variceal bleeding. However, the appropriate diameter of the covered stent during the TIPS procedure remains a subject of debate. To date, there is a lack of strong evidence regarding the most suitable covered stent diameter.
In theory, a shunt with a larger diameter can result in better stent patency, but it can also lead to reduced liver function and a higher incidence of hepatic encephalopathy (HE) after the TIPS procedure. Therefore, the choice of covered stent diameter needs to consider the factors of shunt efficacy and postoperative liver function. At present, the diameters of TIPS-dedicated stents are typically either 8 or 10 mm. Whether stents with these two diameters can meet all the requirements of TIPS procedures is currently unknown. Different races, cirrhosis etiologies, and liver volumes may require different TIPS diameters. For example, in China, most cases of liver cirrhosis are caused by hepatitis B, resulting in the patient having a smaller liver volume. Therefore, in most Chinese studies, the diameters of TIPS stents are mainly 8 mm. Previous studies have shown that TIPS with an 8-mm covered stent has a shunt effect similar to that of a 10-mm covered stent; however, the incidence of postoperative HE is significantly reduced with an 8-mm stent (27% vs. 43%)14. Nevertheless, an 8-mm covered TIPS still has a high incidence of HE.
The residual liver volume is small for patients with severe atrophic cirrhosis of the liver, and whether this necessitates a covered TIPS with a smaller diameter requires further study. However, there is still no dedicated TIPS stent that is \<8 mm in diameter. In this study, we propose an innovative strategy for the creation of a 6-mm shunt to determine if it can achieve a shunt effect similar to that of an 8-mm covered TIPS and reduce the incidence of HE in patients with severe atrophic liver cirrhosis.
- Conditions
- Portal Hypertension Related to Cirrhosis
- Being tested
- During TIPS operation, shunt diameter or diameter of covered stent
- Keywords
- Portal hypertension, TIPS, shunt diameter, hepatic encephalopathy, stent patency
- Medical subject headings
- Hypertension, Portal, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
During TIPS operation, shunt diameter or diameter of covered stentDevice
Transjugular intrahepatic portosystemic shunt (TIPS) is an effective treatment strategy for managing portal hypertension-related variceal bleeding. However, the appropriate diameter of the covered stent during the TIPS procedure remains a subject of debate. To date, there is a lack of strong evidence regarding the most suitable covered stent diameter.
Due to the lack of a dedicated 6-mm covered stent, we first released a 6-mm diameter stent (SD Express; Boston Scientific Co., or Luminexx; Bard Medical Division) in the liver parenchymal segment of the shunt, and then released an 8-mm TIPS stent (Viatorr; WL Gore \&amp; Associates) to create a final 6-mm shunt.
During TIPS operation, shunt diameter or diameter of covered stentDevice
After successful puncture, in the 8-mm shunt group, a balloon with a diameter of 6 mm was used to expand the shunt, and then an 8-mm covered stent was implanted (Viatorr; WL Gore \& Associates, Inc.).
| Study group | Role | What they receive |
|---|---|---|
| 6-mm shunt TIPS group | Experimental | The diameter of TIPS covered stent is 6mm. Receives: Device: During TIPS operation, shunt diameter or diameter of covered stent |
| 8-mm shunt TIPS | Active comparator | The diameter of TIPS covered stent is 8mm. Receives: Device: During TIPS operation, shunt diameter or diameter of covered stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 1- year rates of rebleeding
Measured: From receiving TIPS to one year after the end of treatment
The 2- year rates of rebleeding
Measured: From receiving TIPS to two year after the end of treatment
Secondary outcomes (4)
The 1- year stent patency rates
During the follow-up, there was no thrombosis in the stent and complications related to portal hypertension caused by stent occlusion.
Measured: From receiving TIPS to 1 year after the end of treatment
The 2- year stent patency rates
During the follow-up, there was no thrombosis in the stent and complications related to portal hypertension caused by stent occlusion.
Measured: From receiving TIPS to 2 year after the end of treatment
The 1-year cumulative incidences of overt HE
HE greater than or equal to 2
Measured: From receiving TIPS to 1 year after the end of treatment
The 2-year cumulative incidences of overt HE
HE greater than or equal to 2
Measured: From receiving TIPS to 2 year after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Hypertension Related to CirrhosisStudies 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
- Huang Mingsheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huang Mingsheng, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589531
- Sponsor's protocol ID
- II2024-234-02
- Status last verified
- Aug 2024
- First submitted
- 7 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Incidence of rebleeding in 1 year and 2 years, incidence of overt hepatic encephalopathy in 1 year and 2 years, stent failure, incidence of hepatic encephalopathy, liver function (C-P score, ABI score), and overall survival.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6 Mm Shunt Transjugular Intrahepatic Portosystemic Shunt in Patients with Severe Liver Atrophy and Variceal Bleeding:A Prospective Single-center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06589531
- Acronym / sponsor ID
- II2024-234-02
- Conditions
- Portal Hypertension Related to Cirrhosis
- Keywords
- Portal hypertension, TIPS, shunt diameter, hepatic encephalopathy, stent patency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Huang MingshengUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
Portal hypertension is the most common complication in patients with end-stage liver cirrhosis. Portal hypertension-related complications, such as variceal bleeding, often lead to a poor prognosis. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective treatment strategy for managing portal hypertension-related variceal bleeding. However, the appropriate diameter of the covered stent during the TIPS procedure remains a subject of debate. To date, there is a lack of strong evidence regarding the most suitable covered stent diameter.
In theory, a shunt with a larger diameter can result in better stent patency, but it can also lead to reduced liver function and a higher incidence of hepatic encephalopathy (HE) after the TIPS procedure. Therefore, the choice of covered stent diameter needs to consider the factors of shunt efficacy and postoperative liver function. At present, the diameters of TIPS-dedicated stents are typically either 8 or 10 mm. Whether stents with these two diameters can meet all the requirements of TIPS procedures is currently unknown. Different races, cirrhosis etiologies, and liver volumes may require different TIPS diameters. For example, in China, most cases of liver cirrhosis are caused by hepatitis B, resulting in the patient having a smaller liver volume. Therefore, in most Chinese studies, the diameters of TIPS stents are mainly 8 mm. Previous studies have shown that TIPS with an 8-mm covered stent has a shunt effect similar to that of a 10-mm covered stent; however, the incidence of postoperative HE is significantly reduced with an 8-mm stent (27% vs. 43%)14. Nevertheless, an 8-mm covered TIPS still has a high incidence of HE.
The residual liver volume is small for patients with severe atrophic cirrhosis of the liver, and whether this necessitates a covered TIPS with a smaller diameter requires further study. However, there is still no dedicated TIPS stent that is \<8 mm in diameter. In this study, we propose an innovative strategy for the creation of a 6-mm shunt to determine if it can achieve a shunt effect similar to that of an 8-mm covered TIPS and reduce the incidence of HE in patients with severe atrophic liver cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6-mm shunt TIPS group | Experimental | Device: During TIPS operation, shunt diameter or diameter of covered stentThe diameter of TIPS covered stent is 6mm. |
| 8-mm shunt TIPS | Active comparator | Device: During TIPS operation, shunt diameter or diameter of covered stentThe diameter of TIPS covered stent is 8mm. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed as cirrhosis
- Previous or present endoscopic diagnosis of esophageal and gastric varices bleeding.
- Child -Pugh score C (≤13) or MELD≤18.
- Enhanced image measurement of liver volume ≤1000cm3.
- Have indications for TIPS treatment.
Key exclusion criteria (5 listed)
- Malignant tumor (including hepatocellular carcinoma) or other diseases that will shorten the life span of patients.
- Cavernous portal vein
- Non-cirrhotic portal hypertension (Budd-Chiari syndrome, extrahepatic portal vein obstruction, idiopathic portal hypertension, etc.)
- Spontaneous dominant hepatic encephalopathy 5 congestive heart failure or severe valvular heart failure
- 6. Uncontrollable systemic infection or inflammation 7. Severe pulmonary hypertension 8. Severe renal insufficiency (except hepatogenic renal insufficiency) 9. Rapidly progressing liver failure 10. Contrast agent allergy 11. History of liver transplantation or allogeneic organ transplantation 12. Have a history of TIPS or shunt operation. 13. Pregnancy or lactation 14. Poor compliance 15. Participate in another clinical 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 |
|---|---|---|
| During TIPS operation, shunt diameter or diameter of covered stentTransjugular intrahepatic portosystemic shunt (TIPS) is an effective treatment strategy for managing portal hypertension-related variceal bleeding. However, the appropriate diameter of the covered stent during the TIPS procedure remains a subject of debate. To date, there is a lack of strong evidence regarding the most suitable covered stent diameter. Due to the lack of a dedicated 6-mm covered stent, we first released a 6-mm diameter stent (SD Express; Boston Scientific Co., or Luminexx; Bard Medical Division) in the liver parenchymal segment of the shunt, and then released an 8-mm TIPS stent (Viatorr; WL Gore \&amp; Associates) to create a final 6-mm shunt. | Device | 6-mm shunt TIPS group |
| During TIPS operation, shunt diameter or diameter of covered stentAfter successful puncture, in the 8-mm shunt group, a balloon with a diameter of 6 mm was used to expand the shunt, and then an 8-mm covered stent was implanted (Viatorr; WL Gore \& Associates, Inc.). | Device | 8-mm shunt TIPS |
Primary outcome
The 1- year rates of rebleeding
Time frame: From receiving TIPS to one year after the end of treatment
The 2- year rates of rebleeding
Time frame: From receiving TIPS to two year after the end of treatment
4 secondary outcomes
The 1- year stent patency rates
Time frame: From receiving TIPS to 1 year after the end of treatment
The 2- year stent patency rates
Time frame: From receiving TIPS to 2 year after the end of treatment
The 1-year cumulative incidences of overt HE
Time frame: From receiving TIPS to 1 year after the end of treatment
The 2-year cumulative incidences of overt HE
Time frame: From receiving TIPS to 2 year after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. Incidence of rebleeding in 1 year and 2 years, incidence of overt hepatic encephalopathy in 1 year and 2 years, stent failure, incidence of hepatic encephalopathy, liver function (C-P score, ABI score), and overall survival.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing During TIPS operation, shunt diameter or diameter of covered stent in people with Portal Hypertension Related to Cirrhosis, run by Huang Mingsheng.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huzheng Yan, doctor (8613610176039 ext. 131610176039, yanhzhdr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 1- year rates of rebleeding (time frame: From receiving TIPS to one year after the end of treatment). 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 19 Sep 2024.