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Primary Prevention of Gastric Varices Bleed

NCT05859009 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-12-14

No results posted yet for this study

Summary

Primary prophylaxis of gastric varices is an important area of research, as gastric varices are a common complication of cirrhosis of the liver. Cirrhosis is a condition in which the liver becomes scarred and loses its ability to function properly, and it is a leading cause of morbidity and mortality worldwide. Gastric varices occur in up to 30% of patients with cirrhosis, and they can rupture, leading to life-threatening bleeding. The clinical, epidemiological, and public health context of primary prophylaxis of gastric varices is therefore the need to prevent the development of this complication in patients at risk for cirrhosis and to reduce the associated morbidity and mortality. The clinical trials on primary prophylaxis of gastric varices are therefore focused on evaluating the safety and efficacy of various interventions, such as beta-blockers and endoscopic techniques, in reducing the risk of gastric varices in patients with cirrhosis. The goal of this trial is to find the most effective and safe strategies for primary prophylaxis of gastric varices, in order to improve the outcomes for patients with cirrhosis.

Conditions

  • Gastric Varices Bleeding
  • Endoscopic Ultrasound

Interventions

PROCEDURE

EUS-Guided Therapy of Glue and Coil

This clinical trial aims to evaluate the effectiveness and safety of endoscopic ultrasound (EUS)-guided therapy of glue and coil in the management of gastrointestinal bleeding due to varices. The procedure involves the insertion of a catheter through an endoscope to deliver glue and/or coils to the bleeding site, under EUS guidance. Patients who meet the inclusion criteria will undergo EUS-guided therapy of glue and coil, followed by follow-up assessments to evaluate the outcomes of the procedure, including bleeding recurrence and adverse events.

DRUG

Non-Selective Beta Blockers (Propanolol)

Participants in this arm will receive a daily oral dose of a non-selective beta blocker (such as propranolol) for the duration of the study. Participants will be monitored for side effects and efficacy of the medication.

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Samir C Grover, MD, MEd · Unity Health Toronto

  • Kareem Khalaf, HBSc, MD · Unity Health Toronto

  • Nikko Gimpaya, HBSc, MEd · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-07-01
Completion
2026-07-01

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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 NCT05859009 on ClinicalTrials.gov