Band Ligation Versus Transjugular Intrahepatic Portosystemic Stent Shunt (TIPS) in Cirrhotics With Recurrent Variceal Bleeding Non Responding to Medical Therapy (ENDOvsTIPS)

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00570973
First received: December 10, 2007
Last updated: May 20, 2011
Last verified: May 2011
  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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Recurrence of Variceal Bleeding [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570973

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
Sponsors and Collaborators
Medical University of Vienna
Investigators
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 Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Liver Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014