Gastrointestinal HemorrhagePhase 4ENDOvsTIPSNCT00570973
Band Ligation Versus Transjugular Intrahepatic Portosystemic Stent Shunt (TIPS) in Cirrhotics With Recurrent Variceal Bleeding Non Responding to Medical Therapy
A Phase 4 study testing endoscopic band ligation and TIPS-Implantation in people with Gastrointestinal Hemorrhage and Variceal Bleeding, run by Medical University of Vienna at 4 sites in Austria.
Trial summary
Patients with liver cirrhoses and recent history of variceal bleeding, with HVPG documented non response to medical therapy with non selective beta blockers +/- mononitrates or variceal rebleeding during adequate medical therapy will be randomized to undergo either multi-session endoscopic multi-band ligation and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage, Variceal Bleeding, Cirrhosis
- What is being tested?
- endoscopic band ligation and TIPS-Implantation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesAustria
- Study dates
- Nov 2004to May 2011
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- liver cirrhosis
- bleeding from esophageal varices within the last 6 months
- sufficient medical therapy (at least 80 mg propranolol per day)
- signed written informed consent
Who cannot join
- bleeding of gastric varices
- portal vein thrombosis
- insufficient medical therapy (less than 80 mg propranolol per day)
- exclusion criteria for TIPS/band ligation (anatomy, impaired coagulation parameters, severe encephalopathy, severe liver failure (bilirubin > 10 mg/dl)) congestive heart failure, pulmonary hypertension, polycystic liver disease, presence or suspicion of active systemic, biliary or ascitic fluid infection, known cavernous portal vein occlusion
- Budd Chiari syndrome
Trial locations and contacts
4 sites in 1 country.
Austria4 sites
Medical University of Graz
Graz, 8036
Internal Medicine IV, Krankenhaus der Elisabethinen Linz
Linz, Upper Austria, 4020
Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
Vienna, 1090
Wilhelminenspital der Stadt Wien
Vienna, 1160
About this study
Official title: A Randomized, Controlled, Multicentric Trial Comparing Endoscopic Band Ligation Versus Ransjugular Intrahepatic Portosystemic Stent Shunt in Cirrhotic Patients With Recurrent Variceal Bleeding Non Responding to Medical Therapy
Patients with liver cirrhoses and recent history of variceal bleeding, with HVPG documented non response to medical therapy with non selective beta blockers +/- mononitrates or variceal rebleeding during adequate medical therapy will be randomized to undergo either multi-session endoscopic multi-band ligation and continuation of medication or TIPS placement. Best treatment for this group of cirrhotic patients is not known so far.
Read the detailed description
Reduction of portal pressure are with oral intake of non selective beta blockers, often combined with mononitrates are the method of choice in secondary prophylaxis of esophageal variceal bleeding. However, studies have shown that this therapy is effective only in 20-50% of the patients, documented by a significant drop of the portal pressure with hepatic venous pressure (HVPG) measurements. The best method for secondary prevention in this high risk patient cohort is not known so far. In this randomized controlled study we hypothesise, that a group of 20 vs 20 patients is large enough to discriminate efficacy of prevention of rebleeding in patients receiving TIPS implantation or endoscopic band ligation in patients non responding to medical therapy as secondary prophylaxis of esophageal variceal bleeding.
- Being tested
- endoscopic band ligation, TIPS-Implantation
- Keywords
- Variceal Bleeding, Cirrhosis, Encephalopathy, Endoscopic band ligation, TIPS
- Medical subject headings
- Gastrointestinal Hemorrhage, Fibrosis, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic band ligationProcedure or surgery
Endoscopic Band ligation of esophageal varices, performed every 2-4 weeks until resolution of varices
TIPS-ImplantationProcedure or surgery
Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent, placed once, under fluoroscopic control,
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Endoscopic Band ligation combined with medical therapy (orally, daily administered propranolol and mononitrate) Receives: Procedure: endoscopic band ligation |
| 2 | Active comparator | Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent Receives: Procedure: TIPS-Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Variceal Bleeding
Measured: 2 years
Secondary outcomes (1)
Survival of Patients
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 posted11 Dec 2007 (estimated)
- Study startNov 2004
- Primary completionMay 2011
- Study completionMay 2011
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 Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Arnulf Ferlitsch, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570973
- Sponsor's protocol ID
- ENDOvsTIPS
- Acronym
- ENDOvsTIPS
- Status last verified
- May 2011
- First submitted
- 10 Dec 2007
- Last updated
- 23 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Simonetti RG, Perricone G, Robbins HL, Battula NR, Weickert MO, Sutton R, Khan S. Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD000553. doi: 10.1002/14651858.CD000553.pub3.
PubMed 33089892
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicentric Trial Comparing Endoscopic Band Ligation Versus Ransjugular Intrahepatic Portosystemic Stent Shunt in Cirrhotic Patients With Recurrent Variceal Bleeding Non Responding to Medical Therapy
- ClinicalTrials.gov ID
- NCT00570973
- Acronym / sponsor ID
- ENDOvsTIPS / ENDOvsTIPS
- Keywords
- Variceal Bleeding, Cirrhosis, Encephalopathy, Endoscopic band ligation, TIPS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Dec 2007 (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.
Patients with liver cirrhoses and recent history of variceal bleeding, with HVPG documented non response to medical therapy with non selective beta blockers +/- mononitrates or variceal rebleeding during adequate medical therapy will be randomized to undergo either multi-session endoscopic multi-band ligation and continuation of medication or TIPS placement. Best treatment for this group of cirrhotic patients is not known so far.
Detailed description
Reduction of portal pressure are with oral intake of non selective beta blockers, often combined with mononitrates are the method of choice in secondary prophylaxis of esophageal variceal bleeding. However, studies have shown that this therapy is effective only in 20-50% of the patients, documented by a significant drop of the portal pressure with hepatic venous pressure (HVPG) measurements. The best method for secondary prevention in this high risk patient cohort is not known so far. In this randomized controlled study we hypothesise, that a group of 20 vs 20 patients is large enough to discriminate efficacy of prevention of rebleeding in patients receiving TIPS implantation or endoscopic band ligation in patients non responding to medical therapy as secondary prophylaxis of esophageal variceal bleeding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: endoscopic band ligationEndoscopic Band ligation combined with medical therapy (orally, daily administered propranolol and mononitrate) |
| 2 | Active comparator | Procedure: TIPS-ImplantationTransjugular intrahepatic portosystemic stent shunt with PTFE-covered stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- liver cirrhosis
- bleeding from esophageal varices within the last 6 months
- sufficient medical therapy (at least 80 mg propranolol per day)
- signed written informed consent
Key exclusion criteria (5 listed)
- bleeding of gastric varices
- portal vein thrombosis
- insufficient medical therapy (less than 80 mg propranolol per day)
- exclusion criteria for TIPS/band ligation (anatomy, impaired coagulation parameters, severe encephalopathy, severe liver failure (bilirubin > 10 mg/dl)) congestive heart failure, pulmonary hypertension, polycystic liver disease, presence or suspicion of active systemic, biliary or ascitic fluid infection, known cavernous portal vein occlusion
- Budd Chiari syndrome
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 |
|---|---|---|
| endoscopic band ligationEndoscopic Band ligation of esophageal varices, performed every 2-4 weeks until resolution of varices | Procedure or surgery | 1 |
| TIPS-ImplantationTransjugular intrahepatic portosystemic stent shunt with PTFE-covered stent, placed once, under fluoroscopic control, | Procedure or surgery | 2 |
Primary outcome
Recurrence of Variceal Bleeding
Time frame: 2 years
1 secondary outcome
Survival of Patients
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 23 May 2011.
- Derived from this study: PubMed 33089892Simonetti RG, Perricone G, Robbins HL, Battula NR, Weickert MO, Sutton R, Khan S. Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD000553. doi: 10.1002/14651858.CD000553.pub3.
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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.
Arnulf Ferlitsch, MD principal investigator
Medical University of Vienna
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing endoscopic band ligation and TIPS-Implantation in people with Gastrointestinal Hemorrhage and Variceal Bleeding, run by Medical University of Vienna at 4 sites in Austria.
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 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: finished, as of the sponsor's last update on 23 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Recurrence of Variceal Bleeding (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 NCT00570973, 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 23 May 2011.