Portal HypertensionNCT06122792
Preemptive TIPS for Gastric Variceal Bleeding in Patients With Cirrhosis
A study testing preemptive TIPS and standard second prophylaxis in people with Portal Hypertension and Gastric Varices Bleeding, run by West China Hospital.
Trial summary
The prevalence of gastric varices is approximately 20%. It is important to note that gastric varices tend to bleed more severely, have a higher morbidity and mortality rate, and have a 35% to 90% risk of rebleeding after the cessation of acute hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Portal Hypertension, Gastric Varices Bleeding, Portosystemic Shunt
- What is being tested?
- preemptive TIPS and standard second prophylaxis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis (diagnosed by imaging, laboratory tests, clinical symptoms, or liver biopsy);
- Admission due to acute bleeding from gastric varices (IGV1 or GOV2).
Who cannot join
- Prior treatment with TIPS or surgical shunt;
- Presence of contraindications to endoscopic treatment, carvedilol, or TIPS;
- Presence of hepatocellular carcinoma exceeding Milan criteria;
- Presence of other systemic malignant tumors with expected survival time not exceeding 6 months;
- Presence of uncontrollable infection or sepsis;
- Presence of cardiac, pulmonary, or renal failure;
- Pregnant or lactating women;
- Refusal to sign the informed consent form.
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: Preemptive Transjugular Intrahepatic Portosystemic Shunt for Gastric Variceal Bleeding in Patients With Cirrhosis: A Multicenter Randomized Trial
The prevalence of gastric varices is approximately 20%. It is important to note that gastric varices tend to bleed more severely, have a higher morbidity and mortality rate, and have a 35% to 90% risk of rebleeding after the cessation of acute hemorrhage. Because of the relatively low prevalence of gastric varices, the existing clinical studies have many deficiencies, and there is much controversy in the academic community, the optimal treatment and prevention strategies for gastric varices have not yet been fully defined.
In the last few years, important advances have been made in the treatment and prevention of gastric variceal bleeding in patients with cirrhosis. Experts agree that the combination of pharmacological and endoscopic injection of tissue adhesives should be the first line of therapy in the acute bleeding episode from isolated gastric varices (IGV1) or type 2 gastroesophageal varices (GOV2) varices; whereas transjugular intrahepatic portosystemic shunt (TIPS) is considered a rescue therapy. TIPS has been shown to effectively prevent variceal rebleeding but with a potential increase in the incidence of hepatic encephalopathy and/or liver failure. In this sense, a recent randomized controlled trial (RCT) in fundal variceal bleeding showed that an early TIPS, performed during the first 5 days after patient admission resulted in a significant decrease in failure to control bleeding and early and late rebleeding. However, the study was conducted for 4 years and only included 25 patients. Due to insufficient sample size, it was unable to reflect whether priority TIPS can bring survival benefits to patients with gastric variceal bleeding. Therefore, there is an urgent need for multi-center clinical studies with large samples to provide high-quality evidence in the field of prioritizing TIPS for the treatment of acute gastric variceal bleeding.
The present study aims to compare the preemptive TIPS (performed during the first 72 hours after endoscopy) with standard second prophylaxis (endoscopic injection of tissue adhesives plus carvedilol) for patients with acute bleeding from gastric varices (IGV1 or GOV2). The primary outcome will be a 6-week mortality from inclusion.
- Being tested
- preemptive TIPS, standard second prophylaxis
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preemptive TIPSProcedure or surgery
Also called early TIPS
The TIPS procedure should be performed within 72 hours after the initial endoscopic examination or treatment. An 8 mm Viatorr stent will be used for TIPS establishment. The aim will be to reduce the portal pressure gradient below 12 mm Hg. Embolization, either with coils or glue, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices. After TIPS, anticoagulation will not be used as a rule but is allowed if the attending physician thinks that it is warranted.
standard second prophylaxisProcedure or surgery
Also called endoscopy plus drug treatment
Patients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (carvedilol) will be started with an initial dose of 6.25 mg, the dose of propranolol will be increased to 12.5 mg.
The second elective session of endoscopic injection of tissue adhesives will be performed within the first 28 days after the initial endoscopic treatment. The following sessions will be performed at 28 +/- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new endoscopic injection of tissue adhesives will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | Active comparator | Standard treatment to achieve initial hemostasis: vasoactive drugs (somatostatin or terlipressin) + endoscopic hemostasis according to the center protocol.
Standard combined endoscopic and pharmacological therapy as secondary prophylaxis (carvedilol + repeated endoscopic injection of tissue adhesives until the eradication of the gastric varices). Receives: Procedure: standard second prophylaxis |
| Preemptive TIPS | Experimental | Standard treatment to achieve initial hemostasis: vasoactive drugs (somatostatin or terlipressin) + endoscopic hemostasis according to the center protocol.
Performance of TIPS in the first 72 hours following initial endoscopic hemostasis. Receives: Procedure: preemptive TIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-week mortality
The rate of mortality during the first 6 weeks after inclusion in the study.
Measured: 6 weeks
Secondary outcomes (4)
5-day treatment failure
Incidence of cases requiring adjustment of treatment strategy within 5 days of initial standardised treatment: vomiting of blood or drainage of ≥100 ml of fresh blood from a gastric tube after 2 hours of treatment, hypovolemic shock, drop in haemoglobin of 30 g/L or more within 24 hours without transfusion.
Measured: 5 days
1-year mortality
The rate of mortality during the first 1 year after inclusion in the study.
Measured: 1 year
decompensation events
Rates with rebleeding, new overt ascites (moderate-heavy) or increased degree of ascites, overt hepatic encephalopathy (West-Heaven grades 2-4), or jaundice (total bilirubin >51 mmol/L) from 5 days after initial standardised treatment up to 1 year.
Measured: 1 year
adverse events
Events of various complications such as infections, new tumours, organ failure, peptic ulcers, etc., occurring after randomisation up to the follow-up period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing YouAn Hospital, Renmin Hospital of Wuhan University, Second Affiliated Hospital of Nanchang University, Guangzhou First People's Hospital
- Responsible party
- Principal investigator, luo xuefeng, West China Hospital
- Investigators
- Xuefeng Luo, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122792
- Sponsor's protocol ID
- pTIPS-GV
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Escorsell A, Garcia-Pagan JC, Alvarado-Tapia E, Aracil C, Masnou H, Villanueva C, Bosch J. Pre-emptive TIPS for the treatment of bleeding from gastric fundal varices: Results of a randomised controlled trial. JHEP Rep. 2023 Mar 1;5(6):100717. doi: 10.1016/j.jhepr.2023.100717. eCollection 2023 Jun.
PubMed 37284139
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Transjugular Intrahepatic Portosystemic Shunt for Gastric Variceal Bleeding in Patients With Cirrhosis: A Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT06122792
- Acronym / sponsor ID
- pTIPS-GV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Beijing YouAn Hospital, Renmin Hospital of Wuhan University, Second Affiliated Hospital of Nanchang University, Guangzhou First People's Hospital
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Nov 2023 (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.
The prevalence of gastric varices is approximately 20%. It is important to note that gastric varices tend to bleed more severely, have a higher morbidity and mortality rate, and have a 35% to 90% risk of rebleeding after the cessation of acute hemorrhage. Because of the relatively low prevalence of gastric varices, the existing clinical studies have many deficiencies, and there is much controversy in the academic community, the optimal treatment and prevention strategies for gastric varices have not yet been fully defined.
In the last few years, important advances have been made in the treatment and prevention of gastric variceal bleeding in patients with cirrhosis. Experts agree that the combination of pharmacological and endoscopic injection of tissue adhesives should be the first line of therapy in the acute bleeding episode from isolated gastric varices (IGV1) or type 2 gastroesophageal varices (GOV2) varices; whereas transjugular intrahepatic portosystemic shunt (TIPS) is considered a rescue therapy. TIPS has been shown to effectively prevent variceal rebleeding but with a potential increase in the incidence of hepatic encephalopathy and/or liver failure. In this sense, a recent randomized controlled trial (RCT) in fundal variceal bleeding showed that an early TIPS, performed during the first 5 days after patient admission resulted in a significant decrease in failure to control bleeding and early and late rebleeding. However, the study was conducted for 4 years and only included 25 patients. Due to insufficient sample size, it was unable to reflect whether priority TIPS can bring survival benefits to patients with gastric variceal bleeding. Therefore, there is an urgent need for multi-center clinical studies with large samples to provide high-quality evidence in the field of prioritizing TIPS for the treatment of acute gastric variceal bleeding.
The present study aims to compare the preemptive TIPS (performed during the first 72 hours after endoscopy) with standard second prophylaxis (endoscopic injection of tissue adhesives plus carvedilol) for patients with acute bleeding from gastric varices (IGV1 or GOV2). The primary outcome will be a 6-week mortality from inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Active comparator | Procedure: standard second prophylaxisStandard treatment to achieve initial hemostasis: vasoactive drugs (somatostatin or terlipressin) + endoscopic hemostasis according to the center protocol. Standard combined endoscopic and pharmacological therapy as secondary prophylaxis (carvedilol + repeated endoscopic injection of tissue adhesives until the eradication of the gastric varices). |
| Preemptive TIPS | Experimental | Procedure: preemptive TIPSStandard treatment to achieve initial hemostasis: vasoactive drugs (somatostatin or terlipressin) + endoscopic hemostasis according to the center protocol. Performance of TIPS in the first 72 hours following initial endoscopic hemostasis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cirrhosis (diagnosed by imaging, laboratory tests, clinical symptoms, or liver biopsy);
- Admission due to acute bleeding from gastric varices (IGV1 or GOV2).
Key exclusion criteria (8 listed)
- Prior treatment with TIPS or surgical shunt;
- Presence of contraindications to endoscopic treatment, carvedilol, or TIPS;
- Presence of hepatocellular carcinoma exceeding Milan criteria;
- Presence of other systemic malignant tumors with expected survival time not exceeding 6 months;
- Presence of uncontrollable infection or sepsis;
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 |
|---|---|---|
| preemptive TIPSAlso: early TIPSThe TIPS procedure should be performed within 72 hours after the initial endoscopic examination or treatment. An 8 mm Viatorr stent will be used for TIPS establishment. The aim will be to reduce the portal pressure gradient below 12 mm Hg. Embolization, either with coils or glue, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices. After TIPS, anticoagulation will not be used as a rule but is allowed if the attending physician thinks that it is warranted. | Procedure or surgery | Preemptive TIPS |
| standard second prophylaxisAlso: endoscopy plus drug treatmentPatients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (carvedilol) will be started with an initial dose of 6.25 mg, the dose of propranolol will be increased to 12.5 mg. The second elective session of endoscopic injection of tissue adhesives will be performed within the first 28 days after the initial endoscopic treatment. The following sessions will be performed at 28 +/- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new endoscopic injection of tissue adhesives will be performed. | Procedure or surgery | Standard Therapy |
Primary outcome
6-week mortality
Time frame: 6 weeks
The rate of mortality during the first 6 weeks after inclusion in the study.
4 secondary outcomes
5-day treatment failure
Time frame: 5 days
1-year mortality
Time frame: 1 year
decompensation events
Time frame: 1 year
adverse events
Time frame: 1 year
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 8 Nov 2023.
- Background: PubMed 37284139Escorsell A, Garcia-Pagan JC, Alvarado-Tapia E, Aracil C, Masnou H, Villanueva C, Bosch J. Pre-emptive TIPS for the treatment of bleeding from gastric fundal varices: Results of a randomised controlled trial. JHEP Rep. 2023 Mar 1;5(6):100717. doi: 10.1016/j.jhepr.2023.100717. eCollection 2023 Jun.
- Individual participant dataSharing planned: Undecided
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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.
Xuefeng Luo principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
A study testing preemptive TIPS and standard second prophylaxis in people with Portal Hypertension and Gastric Varices Bleeding, run by West China Hospital.
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 2 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: opening soon, as of the sponsor's last update on 8 Nov 2023. 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 Xiaoze Wang (+8615208207573, wang_xiaoze@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-week mortality (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06122792, which also lists 1 linked publication.
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 8 Nov 2023.