NCT00570973

Brief 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 continuation of medication or TIPS placement. Best treatment for this group of cirrhotic patients is not known so far.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 23, 2011

Status Verified

May 1, 2011

Enrollment Period

6.5 years

First QC Date

December 10, 2007

Last Update Submit

May 20, 2011

Conditions

Gastrointestinal HemorrhageVariceal BleedingCirrhosisEncephalopathy

Keywords

Variceal BleedingCirrhosisEncephalopathyEndoscopic band ligationTIPS

Outcome Measures

Primary Outcomes (1)

  • Recurrence of Variceal Bleeding

    2 years

Secondary Outcomes (1)

  • Survival of Patients

    2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Endoscopic Band ligation combined with medical therapy (orally, daily administered propranolol and mononitrate)

Procedure: endoscopic band ligation

2

ACTIVE COMPARATOR

Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent

Procedure: TIPS-Implantation

Interventions

endoscopic band ligationPROCEDURE

Endoscopic Band ligation of esophageal varices, performed every 2-4 weeks until resolution of varices

1
TIPS-ImplantationPROCEDURE

Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent, placed once, under fluoroscopic control,

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • bleeding of gastric varices
  • portal vein thrombosis
  • insufficient medical therapy (less than 80 mg propranolol per day)
  • Budd Chiari syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Internal Medicine IV, Krankenhaus der Elisabethinen Linz

Linz, Upper Austria, 4020, Austria

Location

Medical University of Graz

Graz, 8036, Austria

Location

Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna

Vienna, 1090, Austria

Location

Wilhelminenspital der Stadt Wien

Vienna, 1160, Austria

Location

Related Publications (1)

  • 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.

    PMID: 33089892DERIVED

MeSH Terms

Conditions

Gastrointestinal HemorrhageFibrosisBrain Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Arnulf Ferlitsch, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 11, 2007

Study Start

November 1, 2004

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 23, 2011

Record last verified: 2011-05

Locations

AU(4)