Clinical trial NCT00161915: Efficacy and Safety of Endoscopic Injection of Fibrin Sealant Versus Endoscopic Ligature for Bleeding Esophageal Varices
Official title: Prospective Randomized Study on the Efficacy of Endoscopic Injection Therapy With Fibrin Sealant Versus Endoscopic Ligature for Acute Hemostasis and the Prophylaxis of Recurrent Bleeding From Esophageal Varices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Esophageal and/or Gastric Varices
Keywords: Liver cirrhosis
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aue
country: Germany
facility: Helios Klinikum Aue
city: Berlin
country: Germany
facility: Krankenhaus Lichtenberg
city: Berlin
country: Germany
facility: Universitätsklinikum Benjamin Franklin
city: Berlin
country: Germany
facility: Krankenhaus Neukölln, Krankenhausbetrieb von Berlin
city: Berlin
country: Germany
facility: Krankenhaus Reinickendorf
city: Berlin
country: Germany
facility: Krankenhaus Zehlendorf
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz GmbH
city: Görlitz
country: Germany
facility: Städtisches Klinikum Görlitz
city: Leipzig
country: Germany
facility: Städtisches Klinikum St. Georg
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann
city: Potsdam
country: Germany
facility: St. Josef Krankenhaus
city: Wittlich
country: Germany
facility: St. Elisabeth Krankenhaus
Study officials:
affiliation: St. Elisabeth Hospital, Wittlich, Germany
name: Thomas Zimmer, MD
role: PRINCIPAL_INVESTIGATOR
References: