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Endoscopic Variceal Ligation in Children

NCT03943784 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-05-09

No results posted yet for this study

Summary

This is an ambispective single-center cohort study of pediatric patients with portal hypertension and esophageal varices. The study was designed to evaluate the efficacy and safety of primary prophylaxis with endoscopic variceal ligation to prevent upper gastrointestinal bleeding compared to non-selected beta-blockers prophylaxis.

Conditions

  • Esophageal Varices in Cirrhosis of the Liver
  • Upper Gastrointestinal Bleeding
  • Endoscopy
  • Child

Interventions

PROCEDURE

Endoscopic Variceal Ligation

Endoscopic varices ligation was performed with a six-shooter multiband ligator (Cook Medical, Limerick, Ireland) if medium to large varices or reddish spots, regardless of the grade of the varix, were observed. Each varix was ligated 1-2 cm above the gastro-esophageal junction, with 1 or 2 rubber bands and using no more than 5 rubber bands per session.

DRUG

Non-Selective Beta-Blocking Agent

Patients of the Propranolol group that presented medium to large esophageal varices without contraindication to Non-Selective Beta-Blockers, received propranolol, 1 mg/Kg/day every 8 hours, titrated to reduce the basal heart rate in 25% and not exceeding 5 mg/Kg/day. Patients were evaluated monthly until this reduction in heart rate was achieved, and every three to six months thereafter.

Sponsors & Collaborators

  • Hospital Vall d'Hebron

    lead OTHER

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2019-04-30
Completion
2019-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03943784 on ClinicalTrials.gov