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

NCT00161915 | Completed Phase 3

• 1 other identifier: 530001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 12

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

Interventions

Fibrin Sealant DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (12)

Helios Klinikum Aue

Aue, 08280, Germany

Location

Krankenhaus Lichtenberg

Berlin, 10365, Germany

Location

Universitätsklinikum Benjamin Franklin

Berlin, 12200, Germany

Location

Krankenhaus Neukölln, Krankenhausbetrieb von Berlin

Berlin, 12313, Germany

Location

Krankenhaus Reinickendorf

Berlin, 13509, Germany

Location

Krankenhaus Zehlendorf

Berlin, 14165, Germany

Location

Klinikum Chemnitz GmbH

Chemnitz, 09116, Germany

Location

Städtisches Klinikum Görlitz

Görlitz, 02828, Germany

Location

Städtisches Klinikum St. Georg

Leipzig, 04129, Germany

Location

Klinikum Ernst von Bergmann

Potsdam, 14467, Germany

Location

St. Josef Krankenhaus

Potsdam, 14471, Germany

Location

St. Elisabeth Krankenhaus

Wittlich, 54516, Germany

Location

MeSH Terms

Conditions

Esophageal and Gastric Varices; Liver Cirrhosis

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Thomas Zimmer, MD

  St. Elisabeth Hospital, Wittlich, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 13, 2005
• Study Start: December 1, 2000
• Study Completion: January 1, 2004
• Last Updated: October 23, 2006

Record last verified: 2006-10

Locations

DE (12)