Self-expandable Esophageal Stent Versus Balloon Tamponade in Refractory Esophageal Variceal Bleeding.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||EFFICACY AND SAFETY OF SELF-EXPANDING ESOPHAGEAL STENT VERSUS ESOPHAGEAL BALLOON TAMPONADE (SENGSTAKEN TUBE) AS A RESCUE THERAPY IN VARICEAL BLEEDING REFRACTORY TO MEDICAL AND ENDOSCOPIC TREATMENT. A MULTICENTRIC, RANDOMIZED CONTROLLED TRIAL.|
- Combined: bleeding + absence of severe adverse events + survival [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
The primary endpoint combines absence of bleeding + absence of severe adverse events probably related to the study devices + survival during the first 15 days after inclusion in the study or at hospital discharge.
Patients to compare are those with liver cirrhosis and acute variceal bleeding (AVB) not controlled with combined pharmacological and endoscopic therapy (see definitions). Those patients will be randomized to receive a self-expandable esophageal stent (SX-Ella-Danis) or balloon tamponade with a Sengstaken-Blakemore tube.
- Bleeding [ Time Frame: 6 months ] [ Designated as safety issue: No ]• Absence of bleeding at day 15th, 42nd and at 6 months from inclusion.
- Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]• Survival at day 15th, 42nd and at 6 months from inclusion.
- Transfusional requirements [ Time Frame: 15 days ] [ Designated as safety issue: No ]• Transfusional requirements (packed red cells, platelets and fresh frozen plasma).
- Adverse events [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]• Individual adverse events.
- Analgesia and sedation requirements [ Time Frame: 15 days ] [ Designated as safety issue: No ]• Analgesia and sedation requirements
- Hospital stay [ Time Frame: 6 months ] [ Designated as safety issue: No ]• Hospital stay
- Applicability of definitive hemostatic therapy. [ Time Frame: 15 days ] [ Designated as safety issue: No ]• Applicability of definitive hemostatic therapy.
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Self-expandable esophageal stent
The patient will receive a self-expandable esophageal stent (SX-Ella-Danis) without endoscopical guidance but under slight sedation. An immediate X-ray will be done to assess the correct placement of the stent.
After a maximum of 7 days, the stent will be removed by using the specifically designed devices.
Self-expandable esophageal stent (SX-Danis, Czesc Republic).
Active Comparator: Sengstaken-Blakemore tube
The esophageal tamponade will be done as described elsewhere. The gastric content will be checked hourly and the correct placement of the tube will be checked by an immediate X-ray. The esophageal balloon will be inflated a maximum of 24 hours.
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|Contact: Angels Escorsell, MD||34932275400 ext firstname.lastname@example.org|
|Barcelona, Spain, 08036|
|Contact: Angels Escorsell, MD 34932275400 ext 4030 email@example.com|
|Sub-Investigator: Juan C Garcia-Pagan, MD|
|Principal Investigator:||Angels Escorsell, MD||Liver Unit. Hospital Clínic|