Self-expandable Esophageal Stent Versus Balloon Tamponade in Refractory Esophageal Variceal Bleeding.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Varices Bleeding Cirrhosis |
Device: Stent Device: Tamponade |
Phase 3 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 46 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
Device: Stent
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.
|
Device: Tamponade
Sengstaken-Blakemore tube
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 Milan criteria.
- Terminal disease.
- No written consent to participate in the study.
Contacts and Locations| Contact: Angels Escorsell, MD | 34932275400 ext 4030 | aescor@clinic.ub.es |
| Spain | |
| Hospital Clinic | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Angels Escorsell, MD 34932275400 ext 4030 aescor@clinic.ub.es | |
| Sub-Investigator: Juan C Garcia-Pagan, MD | |
| Principal Investigator: | Angels Escorsell, MD | Liver Unit. Hospital Clínic |
More Information
No publications provided
| Responsible Party: | Angels Escorsell, Consultant. Liver Unit, Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT01242280 History of Changes |
| Other Study ID Numbers: | PE08001, PI080504 |
| Study First Received: | August 4, 2010 |
| Last Updated: | March 16, 2012 |
| Health Authority: | Spain: Ministerio de Ciencia e Innovación. Subdirección general de evaluación y fomento de la investigación. |
Keywords provided by Hospital Clinic of Barcelona:
|
Acute variceal bleeding Massive bleeding Liver Cirrhosis |
Esophageal tamponade Esophageal stent Acute variceal bleeding refractory to medical and endoscopic therapy |
Additional relevant MeSH terms:
|
Esophageal and Gastric Varices Varicose Veins Esophageal Diseases Hemorrhage Liver Cirrhosis Fibrosis Gastrointestinal Diseases |
Digestive System Diseases Hypertension, Portal Liver Diseases Pathologic Processes Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013