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

Primary Purpose

Gastrointestinal Hemorrhage, Variceal Bleeding, Cirrhosis

Status

Completed

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

endoscopic band ligation

TIPS-Implantation

About this trial

This is an interventional prevention trial for Gastrointestinal Hemorrhage focused on measuring Variceal Bleeding, Cirrhosis, Encephalopathy, Endoscopic band ligation, TIPS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Internal Medicine IV, Krankenhaus der Elisabethinen Linz
Medical University of Graz
Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
Wilhelminenspital der Stadt Wien

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

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

Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent

Outcomes

Primary Outcome Measures

Recurrence of Variceal Bleeding

Secondary Outcome Measures

Survival of Patients

Full Information

NCT ID

NCT00570973

First Posted

December 10, 2007

Last Updated

May 20, 2011

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00570973

Brief Title

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

Acronym

ENDOvsTIPS

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

November 2004 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Hemorrhage, Variceal Bleeding, Cirrhosis, Encephalopathy

Keywords

Variceal Bleeding, Cirrhosis, Encephalopathy, Endoscopic band ligation, TIPS

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent

Intervention Type

Procedure

Intervention Name(s)

endoscopic band ligation

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

TIPS-Implantation

Intervention Description

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

Primary Outcome Measure Information:

Title

Recurrence of Variceal Bleeding

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Survival of Patients

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnulf Ferlitsch, MD

Organizational Affiliation

Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Internal Medicine IV, Krankenhaus der Elisabethinen Linz

City

Linz

State/Province

Upper Austria

ZIP/Postal Code

4020

Country

Austria

Facility Name

Medical University of Graz

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

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

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Wilhelminenspital der Stadt Wien

City

Vienna

ZIP/Postal Code

1160

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

33089892

Citation

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.

Results Reference

derived

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

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