Band Ligation Versus Transjugular Intrahepatic Portosystemic Stent Shunt (TIPS) in Cirrhotics With Recurrent Variceal Bleeding Non Responding to Medical Therapy (ENDOvsTIPS)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Hemorrhage Variceal Bleeding Cirrhosis Encephalopathy |
Procedure: endoscopic band ligation Procedure: TIPS-Implantation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
- Recurrence of Variceal Bleeding [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Survival of Patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2004 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Endoscopic Band ligation combined with medical therapy (orally, daily administered propranolol and mononitrate)
|
Procedure: endoscopic band ligation
Endoscopic Band ligation of esophageal varices, performed every 2-4 weeks until resolution of varices
|
|
Active Comparator: 2
Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent
|
Procedure: TIPS-Implantation
Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent, placed once, under fluoroscopic control,
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Austria | |
| Internal Medicine IV, Krankenhaus der Elisabethinen Linz | |
| Linz, Upper Austria, Austria, 4020 | |
| Medical University of Graz | |
| Graz, Austria, 8036 | |
| Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna | |
| Vienna, Austria, 1090 | |
| Wilhelminenspital der Stadt Wien | |
| Vienna, Austria, 1160 | |
| Principal Investigator: | Arnulf Ferlitsch, MD | Medical University of Vienna |
More Information
No publications provided
| Responsible Party: | Arnulf Ferlitsch, MD, Gastroenterology and Hepatology, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00570973 History of Changes |
| Other Study ID Numbers: | ENDOvsTIPS |
| Study First Received: | December 10, 2007 |
| Last Updated: | May 20, 2011 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Medical University of Vienna:
|
Variceal Bleeding Cirrhosis Encephalopathy Endoscopic band ligation TIPS |
Additional relevant MeSH terms:
|
Gastrointestinal Hemorrhage Hemorrhage Liver Cirrhosis Fibrosis Brain Damage, Chronic Delirium Encephalitis Hepatic Encephalopathy Neurotoxicity Syndromes Gastrointestinal Diseases Digestive System Diseases Pathologic Processes Liver Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Confusion Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Liver Failure Hepatic Insufficiency Brain Diseases, Metabolic Metabolic Diseases Poisoning |
ClinicalTrials.gov processed this record on May 16, 2013