Self-expandable Esophageal Stent Versus Balloon Tamponade in Refractory Esophageal Variceal Bleed… (NCT01242280) | Clinical Trial Compass
CompletedPhase 3
Self-expandable Esophageal Stent Versus Balloon Tamponade in Refractory Esophageal Variceal Bleeding.
Spain28 participantsStarted 2010-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
The study will include all patients with cirrhosis admitted to the hospital because an acute esophageal variceal bleeding defined according to Baveno II criteria (5) and who will achieve the following criteria:
* Failure to control bleeding despite pharmacological (somatostatin 3 or 6 mg/12h iv or terlipressin, 2mg/4h iv) AND endoscopic therapy (esophageal banding ligation preferably or sclerotherapy). Failure to control bleeding was defined, according to Baveno IV criteria (6), as evidence of continuous digestive bleeding and any of the following:
* Hematemesis (or naso-gastric aspirate \> 100 ml of fresh blood) \> 2h after the start of combined pharmacological and endoscopic therapy.
* Decrease in hemoglobin values \> 3g vs previous values (without blood transfusion).
* Massive bleeding. Acute variceal bleeding uncontrolled despite pharmacological therapy started at any moment, with no need of previous endoscopic therapy. Uncontrolled bleeding is defined as an upper digestive bleeding in which no hemodynamic stability (systolic arterial pressure \> 70 mmHg and heart rate \< 100 bpm) could be achieved.
Exclusion Criteria:
* Age \< 18 years.
* Esophageal rupture.
* Esophageal, gastric or upper respiratory tract tumor.
* Esophageal stenosis.
* Recent esophageal surgery.
* Previous esophageal tamponade to treat the index bleed.
* Big hiatal hernia precluding the correct placement of the esophageal devices.
* Known hepatocellular carcinoma surpassing…
What they're measuring
1
Combined: bleeding + absence of severe adverse events + survival