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Self-expandable Esophageal Stent Versus Balloon Tamponade in Refractory Esophageal Variceal Bleeding.

NCT01242280 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-02-05

No results posted yet for this study

Summary

In the last years, important advances have been done in the treatment and prevention of esophageal variceal bleeding. Experts agree that the combination of pharmacological and endoscopic therapy should be the first line therapy in the acute bleeding episode; whereas TIPS (transjugular intrahepatic portosystemic shunt) is considered a rescue therapy. Nevertheless, some patients would require different therapies to act as a "bridge" until definitive therapy can be instituted. Balloon tamponade (using the Sengstaken tube) represents, up to now, the most widely used temporary "bridge" to TIPS. However, balloon tamponade is associated with a high incidence of serious adverse events. Recently, the use of self-expanding metal stents have been introduced in the treatment of acute variceal bleeding showing a very high hemostatic efficacy with no adverse events. The present study is directed to compare the efficacy free of adverse events and mortality of self-expanding metal stents vs balloon tamponade in patients with variceal bleeding refractory to medical and endoscopic therapy.

Conditions

Interventions

DEVICE

Stent

Self-expandable esophageal stent (SX-Danis, Czesc Republic).

DEVICE

Tamponade

Sengstaken-Blakemore tube

Sponsors & Collaborators

  • Germans Trias i Pujol Hospital

    collaborator OTHER

  • Hospital Universitario Ramon y Cajal

    collaborator OTHER

  • Puerta de Hierro University Hospital

    collaborator OTHER

  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER

  • Hospital Universitario Central de Asturias

    collaborator OTHER

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Angels Escorsell, MD · Liver Unit. Hospital Clínic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01242280 on ClinicalTrials.gov