NCT00563602

Brief Summary

This is a prospective trial of random distribution, open, parallel group, in which patients with esophagic variceal bleeding will be randomized into two treatment groups, after controlling acute bleeding. All patients received standard medical therapy with b-blockers and endoscopic ligation (LEV) of esophageal varices. The control group will be assigned to receive LEV + Nadolol + MNI. The experimental group will be assigned to receive treatment according to the hemodynamic response. All patients included in the experimental group received LEV and pharmacological treatment nadolol alone or combined with MNI or Prazosin (PZ)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

November 26, 2007

Status Verified

November 1, 2007

First QC Date

November 21, 2007

Last Update Submit

November 22, 2007

Conditions

Portal HypertensionComplications of Cirrhosis

Keywords

Portal hypertensionPrevention of rebleedingComplications of cirrhosisPortal hemodynamicPrazosineNadololisosorbide mononitrate

Outcome Measures

Primary Outcomes (1)

  • Rebleeding

    1-2 Years

Secondary Outcomes (2)

  • Survival

    1-2 Years

  • Adverse effects

    1-2 Years

Study Arms (2)

2

ACTIVE COMPARATOR

Standard Therapy: Endoscopic ligation (LEV) + Nadolol + Isosorbide mononitrate (MNI)(drugs carefully titrated until achieve maximum tolerated dose)

Other: Hemodynamic guided therapy

1

EXPERIMENTAL

Hemodynamic guided therapy: 1\) LEV + Nadolol. HVPG measurement: if response, no changes, if not, switch to 2) LEV + Nadolol + MNI. HVPG measurement: if response, no changes, if not, switch to: 3) LEV + Nadolol + Prazosin. (drugs carefully titrated until achieve maximum tolerated dose)

Other: Hemodynamic guided therapy

Interventions

Hemodynamic guided therapyOTHER

To switch two or more different treatments for the prevention of variceal rebleeding according to the hemodynamic response. All patients in the experimental group will begin by: 1\) LEV + Nadolol. HVPG measurement: if response, no changes, if not, switch to 2) LEV + Nadolol + MNI. HVPG measurement: if response, no changes, if not, switch to: 3) LEV + Nadolol + Prazosin. (drugs carefully titrated until achieve maximum tolerated dose)

12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All the patients admitted in emergencies in which 1) with gastrointestinal bleeding due to esophageal varices assessed by endoscopy, will be included.
  • We define esophagic variceal bleeding as the endoscopic finding of any the following signs: 1) active variceal bleeding 2) clot or platelet cluster or 3 ) esophageal varices associated to red blood in esophagogastric lumen in the absence of other sources of bleeding.
  • Clinical criteria and / or analytical, ultrasound and / or liver biopsy consistent with the diagnosis of liver cirrhosis.
  • Written informed consent to participate in the study.
  • Patients in fertile age should use barrier methods to prevent pregnancy during the entire study. The pregnancy test prior to the study must be negative

You may not qualify if:

  • Age \<18 or\> 80 years.
  • Patients not eligible for active treatment due to any underlying morbid condition (terminals). Here are included those patients with advanced liver disfunction (Child-Pugh \>) or any patient with life expectancy \< 6 mo.
  • Refuse to participate in the study.
  • Bleeding due to causes other than the esophageal varices.
  • Failure in the control of the acute bleeding (index episode).
  • Pretreatment through elective LEV program, sclerotherapy or combined β- blockers plus nitrates, or portosystemic shunt (surgical or percutaneous).
  • Contraindication for β- blockers and MNI (not exclude patients with contraindication for one of these drugs) or endoscopic procedures.
  • Pregnancy.
  • Presence multiple hepatocellular carcinoma or only diameter \> 5 cm.
  • Portal vein thrombosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HospitalSCSP

Barcelona, Barcelona, 08025, Spain

RECRUITING

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Candid Villanueva, MD

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Candid Villanueva, MD

CONTACT

+34620955006cvillanueva@santpau.es

Jordi Virgili

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

August 1, 2007

Study Completion

November 1, 2007

Last Updated

November 26, 2007

Record last verified: 2007-11

Locations

ES(1)