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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Endoscopic Band ligation combined with medical therapy (orally, daily administered propranolol and mononitrate) |
|
| 2 | Active Comparator | Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic band ligation | Procedure | Endoscopic Band ligation of esophageal varices, performed every 2-4 weeks until resolution of varices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of Variceal Bleeding | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival of Patients | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnulf Ferlitsch, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internal Medicine IV, Krankenhaus der Elisabethinen Linz | Linz | Upper Austria | 4020 | Austria | ||
| Medical University of Graz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33089892 | Derived | 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. |
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| TIPS-Implantation | Procedure | Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent, placed once, under fluoroscopic control, |
|
| Graz |
| 8036 |
| Austria |
| Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna | Vienna | 1090 | Austria |
| Wilhelminenspital der Stadt Wien | Vienna | 1160 | Austria |
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D005355 | Fibrosis |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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