NCT01242280

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

4.4 years

First QC Date

August 4, 2010

Last Update Submit

February 4, 2015

Conditions

Esophageal VaricesBleedingCirrhosis

Keywords

Acute variceal bleedingMassive bleedingLiver CirrhosisEsophageal tamponadeEsophageal stent

Outcome Measures

Primary Outcomes (1)

  • Combined: bleeding + absence of severe adverse events + survival

    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.

    15 days

Secondary Outcomes (7)

  • Bleeding

    6 months

  • Survival

    6 months

  • Transfusional requirements

    15 days

  • Adverse events

    15 days

  • Analgesia and sedation requirements

    15 days

  • +2 more secondary outcomes

Study Arms (2)

Self-expandable esophageal stent

ACTIVE COMPARATOR

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

Sengstaken-Blakemore tube

ACTIVE COMPARATOR

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

Interventions

StentDEVICE

Self-expandable esophageal stent (SX-Danis, Czesc Republic).

Self-expandable esophageal stent
TamponadeDEVICE

Sengstaken-Blakemore tube

Sengstaken-Blakemore tube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

Location

Related Publications (1)

  • Escorsell A, Pavel O, Cardenas A, Morillas R, Llop E, Villanueva C, Garcia-Pagan JC, Bosch J; Variceal Bleeding Study Group. Esophageal balloon tamponade versus esophageal stent in controlling acute refractory variceal bleeding: A multicenter randomized, controlled trial. Hepatology. 2016 Jun;63(6):1957-67. doi: 10.1002/hep.28360. Epub 2016 Jan 14.

    PMID: 26600191DERIVED

MeSH Terms

Conditions

Esophageal and Gastric VaricesHemorrhageFibrosisLiver Cirrhosis

Interventions

Stents

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Angels Escorsell, MD

    Liver Unit. Hospital Clínic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant. Liver Unit

Study Record Dates

First Submitted

August 4, 2010

First Posted

November 17, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

ES(1)