Decompensated CirrhosisNCT01370161
Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for Acute Variceal Bleeding in Patients With Advanced Cirrhosis
A study testing TIPS treatment and Medical treatment in people with Decompensated Cirrhosis and Bleeding Varices, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The purpose of this study is to determine whether early use of transjugular intrahepatic portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to prolong the survival in patients with advanced cirrhosis and acute variceal bleeding. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Decompensated Cirrhosis, Bleeding Varices
- What is being tested?
- TIPS treatment and Medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to 30 Sep 2018
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of cirrhosis (clinical or by liver biopsy)
- Admission due to acute bleeding from oesophageal or gastric (GOV1 or GOV2) varices
- Child-Pugh Class C (Child-Pugh score less than or equal to 13) or Child-Pugh class B
- Signed written informed consent
Who cannot join
- Patients not fulfilling inclusion criteria
- Pregnancy or breast-feeding
- Confirmed hepatocellular carcinoma
- Creatinine greater than 3 mg/dl
- Terminal hepatic failure (Child-Pugh score greater than 13)
- Previous treatment with TIPS or combined pharmacological and endoscopic treatment to prevent rebleeding
Show all 10Show fewer
- Fundal or ectopic gastric variceal bleeding (IGV1 or IGV2)
- Complete portal vein thrombosis or portal cavernoma
- Congestive heart failure New York Heart Association (NYHA) greater than III or medical history of pulmonary hypertension
- Spontaneous recurrent hepatic encephalopathy
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Early Transjugular Intrahepatic Portosystemic Shunt With Polytetrafluoroethylene Covered Stents Versus Standard Medical Therapy for Acute Variceal Bleeding in Patients With Advanced Cirrhosis
The purpose of this study is to determine whether early use of transjugular intrahepatic portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to prolong the survival in patients with advanced cirrhosis and acute variceal bleeding.
- Conditions
- Decompensated Cirrhosis, Bleeding Varices
- Being tested
- TIPS treatment, Medical treatment
- Keywords
- transjugular intrahepatic portosystemic shunt, TIPS, variceal bleeding, liver cirrhosis, hepatitis B
- Medical subject headings
- Liver Cirrhosis, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPS treatmentProcedure or surgery
Also called Transjugular intrahepatic portosystemic shunt (TIPS)
- A 8 mm Fluency stent will be used. The aim will be to reduce the portal pressure gradient (PPG) below to 12 mm Hg or 25-75% of baseline.
- Embolisation, either with coils or bucrylate, 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.
Medical treatmentDrug
Also called Non-selective beta blocker + Endoscopic variceal ligation
Patients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (propranolol) will be started with an initial dose of 40 mg, the dose of propranolol will be increased/decreased step by step to achieve a baseline heart rate of 55 bpm, or 25% reduction of basal heart rate or up to the maximum tolerated dose of propranolol.
The second elective session of endoscopic band ligation will be performed within the first 7-14 days after the initial endoscopic treatment. The following sessions will be performed at 14 +/- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new band ligation will be performed.
| Study group | Role | What they receive |
|---|---|---|
| TIPS treatment | Experimental | Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.TIPS will be performed as soon as possible once the patients are enrolled in the study, always within the first 72 hours after the diagnostic endoscopy (preferably in the first 24 hours).Vasoactive drugs will be continued until the TIPS is performed and antibiotics will be continued for 5-7 days. Receives: Procedure: TIPS treatment |
| Medical treatment | Active comparator | Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.Patients will be treated with non-selective beta-blockers (propranolol)on day 5. In case of contraindications or intolerance to beta-blockers, patients will not receive pharmacological treatment (beta-blockers) and the only treatment to prevent rebleeding will be endoscopic band ligation. Receives: Drug: Medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of survival without liver transplantation
Measured: 2 years
Secondary outcomes (3)
Number of participants failed to control acute variceal bleeding within 5 days, 6 weeks and 1 year
Measured: 1 years
Number of bleeding related death
Measured: 2 years
Number of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, hepatic encephalopathy)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJul 2011
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Decompensated 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohong Han, Air Force Military Medical University, China
- Investigators
- Guohong Han, PhD & MD, Principal investigator, Xijing Hospital of Digestive Diseases, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370161
- Sponsor's protocol ID
- XHDD 002
- Other IDs
- FMMU-XHDD 002
- Status last verified
- Jan 2019
- First submitted
- 7 Jun 2011
- Last updated
- 17 Jan 2019
- Results posted
- No
Publications
Garcia-Pagan JC, Caca K, Bureau C, Laleman W, Appenrodt B, Luca A, Abraldes JG, Nevens F, Vinel JP, Mossner J, Bosch J; Early TIPS (Transjugular Intrahepatic Portosystemic Shunt) Cooperative Study Group. Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med. 2010 Jun 24;362(25):2370-9. doi: 10.1056/NEJMoa0910102.
PubMed 20573925Lv Y, Yang Z, Liu L, Li K, He C, Wang Z, Bai W, Guo W, Yu T, Yuan X, Zhang H, Xie H, Yao L, Wang J, Li T, Wang Q, Chen H, Wang E, Xia D, Luo B, Li X, Yuan J, Han N, Zhu Y, Niu J, Cai H, Xia J, Yin Z, Wu K, Fan D, Han G; AVB-TIPS Study Group. Early TIPS with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial. Lancet Gastroenterol Hepatol. 2019 Aug;4(8):587-598. doi: 10.1016/S2468-1253(19)30090-1. Epub 2019 May 29.
PubMed 31153882
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Transjugular Intrahepatic Portosystemic Shunt With Polytetrafluoroethylene Covered Stents Versus Standard Medical Therapy for Acute Variceal Bleeding in Patients With Advanced Cirrhosis
- ClinicalTrials.gov ID
- NCT01370161
- Acronym / sponsor ID
- XHDD 002
- Conditions
- Decompensated Cirrhosis, Bleeding Varices
- Keywords
- transjugular intrahepatic portosystemic shunt, TIPS, variceal bleeding, liver cirrhosis, hepatitis B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 9 Jun 2011 (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.
The purpose of this study is to determine whether early use of transjugular intrahepatic portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to prolong the survival in patients with advanced cirrhosis and acute variceal bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPS treatment | Experimental | Procedure: TIPS treatmentInitial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.TIPS will be performed as soon as possible once the patients are enrolled in the study, always within the first 72 hours after the diagnostic endoscopy (preferably in the first 24 hours).Vasoactive drugs will be continued until the TIPS is performed and antibiotics will be continued for 5-7 days. |
| Medical treatment | Active comparator | Drug: Medical treatmentInitial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.Patients will be treated with non-selective beta-blockers (propranolol)on day 5. In case of contraindications or intolerance to beta-blockers, patients will not receive pharmacological treatment (beta-blockers) and the only treatment to prevent rebleeding will be endoscopic band ligation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of cirrhosis (clinical or by liver biopsy)
- Admission due to acute bleeding from oesophageal or gastric (GOV1 or GOV2) varices
- Child-Pugh Class C (Child-Pugh score less than or equal to 13) or Child-Pugh class B
- Signed written informed consent
Key exclusion criteria (10 listed)
- Patients not fulfilling inclusion criteria
- Pregnancy or breast-feeding
- Confirmed hepatocellular carcinoma
- Creatinine greater than 3 mg/dl
- Terminal hepatic failure (Child-Pugh score greater than 13)
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 |
|---|---|---|
| TIPS treatmentAlso: Transjugular intrahepatic portosystemic shunt (TIPS)1. A 8 mm Fluency stent will be used. The aim will be to reduce the portal pressure gradient (PPG) below to 12 mm Hg or 25-75% of baseline. 2. Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices. 3. 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 | TIPS treatment |
| Medical treatmentAlso: Non-selective beta blocker + Endoscopic variceal ligationPatients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (propranolol) will be started with an initial dose of 40 mg, the dose of propranolol will be increased/decreased step by step to achieve a baseline heart rate of 55 bpm, or 25% reduction of basal heart rate or up to the maximum tolerated dose of propranolol. The second elective session of endoscopic band ligation will be performed within the first 7-14 days after the initial endoscopic treatment. The following sessions will be performed at 14 +/- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new band ligation will be performed. | Drug | Medical treatment |
Primary outcome
Number of survival without liver transplantation
Time frame: 2 years
3 secondary outcomes
Number of participants failed to control acute variceal bleeding within 5 days, 6 weeks and 1 year
Time frame: 1 years
Number of bleeding related death
Time frame: 2 years
Number of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, hepatic encephalopathy)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Background: PubMed 20573925Garcia-Pagan JC, Caca K, Bureau C, Laleman W, Appenrodt B, Luca A, Abraldes JG, Nevens F, Vinel JP, Mossner J, Bosch J; Early TIPS (Transjugular Intrahepatic Portosystemic Shunt) Cooperative Study Group. Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med. 2010 Jun 24;362(25):2370-9. doi: 10.1056/NEJMoa0910102.
- Derived from this study: PubMed 31153882Lv Y, Yang Z, Liu L, Li K, He C, Wang Z, Bai W, Guo W, Yu T, Yuan X, Zhang H, Xie H, Yao L, Wang J, Li T, Wang Q, Chen H, Wang E, Xia D, Luo B, Li X, Yuan J, Han N, Zhu Y, Niu J, Cai H, Xia J, Yin Z, Wu K, Fan D, Han G; AVB-TIPS Study Group. Early TIPS with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial. Lancet Gastroenterol Hepatol. 2019 Aug;4(8):587-598. doi: 10.1016/S2468-1253(19)30090-1. Epub 2019 May 29.
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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.
Guohong Han, PhD & MD principal investigator
Xijing Hospital of Digestive Diseases, Fourth Military Medical 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 TIPS treatment and Medical treatment in people with Decompensated Cirrhosis and Bleeding Varices, run by Air Force Military Medical University, China 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 17 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of survival without liver transplantation (time frame: 2 years). 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 NCT01370161, which also lists 2 linked publications.
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 17 Jan 2019.