Efficacy and Safety of Endoscopic Injection of Fibrin Sealant Versus Endoscopic Ligature for Bleeding Esophageal Varices

NCT ID: NCT00161915

Last Updated: 2006-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31
• Study Completion Date: 2004-01-31

Brief Summary

The purpose of this study was to assess whether endoscopic sclerotherapy with Fibrin Sealant was superior to ligature, with or without Polidocanol, in achieving hemostasis in bleeding esophageal varices and preventing rebleeding. Therapeutic success was defined as survival of the first seven days without clinically significant bleeding.

Conditions

Esophageal and/or Gastric Varices

Keywords

Liver cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Fibrin Sealant

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Included in the study were patients with proven bleeding from esophageal varices due to liver cirrhosis:

• with a minimum age of 18 years,
• with bleeding symptoms (hematemesis, melena, hematochezia, hypotension, tachycardia) that had lasted not longer than 48 hours prior to hospital admission,
• who were expected to be hospitalized for at least seven days,
• who agreed to participate in the study.

Randomization did not take place if another therapy was medically indicated for any reason.

Exclusion Criteria

Patients were excluded from the study:

• in whom introduction of an endoscope was not possible for technical reasons,
• who had received an alternative endoscopic treatment to eradicate varices during the last three months (sclerotherapy, ligation),
• who had proven additional fundus bleeding from varices or bleeding from a hypertensive gastropathy,
• who had end stage tumor disease or end stage liver cirrhosis (Child Pugh class C with organ complications, such as hepatonephric syndrome, infected ascites etc.),
• who were pregnant or breast feeding,
• who had a known pulmonary disease combined with restricted lung function or right ventricular failure,
• who had congenital or acquired coagulopathies of non-hepatic origin,
• who were currently participating or had participated in another study during the past 30 days or had already been included in this study once,
• who were treated with drugs to decrease portal vein pressure (somatostatin, somatostatin analogs, terlipressin, glycylpressin, except β-blockers and nitrates),
• who had shown an allergic reaction to thrombin or aprotinin,
• who had a heparin-induced thrombocytopenia Type I or Type II.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Principal Investigators

Thomas Zimmer, MD

Role: PRINCIPAL_INVESTIGATOR

St. Elisabeth Hospital, Wittlich, Germany

Locations

Helios Klinikum Aue

Aue, , Germany

Krankenhaus Lichtenberg

Berlin, , Germany

Universitätsklinikum Benjamin Franklin

Berlin, , Germany

Krankenhaus Neukölln, Krankenhausbetrieb von Berlin

Berlin, , Germany

Krankenhaus Reinickendorf

Berlin, , Germany

Krankenhaus Zehlendorf

Berlin, , Germany

Klinikum Chemnitz GmbH

Chemnitz, , Germany

Städtisches Klinikum Görlitz

Görlitz, , Germany

Städtisches Klinikum St. Georg

Leipzig, , Germany

Klinikum Ernst von Bergmann

Potsdam, , Germany

St. Josef Krankenhaus

Potsdam, , Germany

St. Elisabeth Krankenhaus

Wittlich, , Germany

Countries

Germany

Other Identifiers

530001

Identifier Type: -

Identifier Source: org_study_id