Self-expandable Esophageal Stent Versus Balloon Tamponade in Refractory Esophageal Variceal Bleeding.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01242280|
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : February 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Varices Bleeding Cirrhosis||Device: Stent Device: Tamponade||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Esophageal Stent is More Effective Than Tamponade Controlling Refractory Esophageal Variceal Bleeding: a Randomized Controlled Trial|
|Study Start Date :||January 2010|
|Primary Completion Date :||June 2014|
|Study Completion Date :||June 2014|
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.
- Combined: bleeding + absence of severe adverse events + survival [ Time Frame: 15 days ]
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 ]• Absence of bleeding at day 15th, 42nd and at 6 months from inclusion.
- Survival [ Time Frame: 6 months ]• Survival at day 15th, 42nd and at 6 months from inclusion.
- Transfusional requirements [ Time Frame: 15 days ]• Transfusional requirements (packed red cells, platelets and fresh frozen plasma).
- Adverse events [ Time Frame: 15 days ]• Individual adverse events.
- Analgesia and sedation requirements [ Time Frame: 15 days ]• Analgesia and sedation requirements
- Hospital stay [ Time Frame: 6 months ]• Hospital stay
- Applicability of definitive hemostatic therapy. [ Time Frame: 15 days ]• Applicability of definitive hemostatic therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242280
|Barcelona, Spain, 08036|
|Principal Investigator:||Angels Escorsell, MD||Liver Unit. Hospital Clínic|