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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hospital Clinic of Barcelona
Sponsor:
Collaborators:
Germans Trias i Pujol Hospital
Hospital Universitario Ramon y Cajal
Puerta de Hierro University Hospital
Hospital General Universitario Gregorio Marañon
Hospital Universitario Central de Asturias
Information provided by (Responsible Party):
Angels Escorsell, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01242280
First received: August 4, 2010
Last updated: March 14, 2014
Last verified: March 2014
  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: Esophageal Stent is More Effective Than Tamponade Controlling Refractory Esophageal Variceal Bleeding: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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: June 2014
Primary Completion Date: December 2013 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242280

Contacts
Contact: Angels Escorsell, MD 34932275400 ext 4030 aescor@clinic.ub.es

Locations
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         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Germans Trias i Pujol Hospital
Hospital Universitario Ramon y Cajal
Puerta de Hierro University Hospital
Hospital General Universitario Gregorio Marañon
Hospital Universitario Central de Asturias
Investigators
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
Study First Received: August 4, 2010
Last Updated: March 14, 2014
Health Authority: Spain: Ministry of Health

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:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014