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Primary Prevention of Gastric Varices Bleed

NCT ID: NCT05859009

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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Primary gastric varices (GV) are a condition that affects 17% of patients with liver cirrhosis who have not previously received treatment, either endoscopic or pharmacologic. Although the incidence of GV is lower than oesophageal varices (EV) and the bleeding rate is also less frequent, GV bleeding is more severe and is associated with higher re-bleeding and death rates when compared to EV. The management of acute GV bleeding is well established, but the primary prophylaxis (PP) for certain types of GV remains unclear. The management of GOV-1 (gastroesophageal varices type 1) is recommended as for EV, but for isolated gastric varices type 1 (IGV-1) and gastroesophageal varices type 2 (GOV-2), PP is not clearly defined. Existing guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) do not provide strong recommendations for primary prophylaxis of IGV-1/GOV-2. While EASL suggests the use of nonselective beta-blockers (NSBB) for IGV-1/ GOV-2 based on one Randomized Controlled Trial (RCT) from 2011 on 89 patients, comparing NSBB vs. endoscopic glue injection for primary prophylaxis in GOV-2/IGV-1. The Baveno consensus VII recommends NSBB in PP but emphasizes the need for further studies. However, no study compares NSBB vs. EUS-GV management in primary prophylaxis. Establishing primary prophylaxis for IGV-1/GOV-2 is even more important as the 2-year incidence of variceal bleeding from IGV1 and GOV-2 type of varices is more frequent and profuse (78% and 54%, respectively) than the lesser curve (GOV-1) varices (28%).

Clinical research has shown that the use of non-selective beta-blockers, such as propranolol and nadolol, can be effective in reducing the risk of developing gastric varices in patients with cirrhosis. These medications work by reducing blood flow to the dilated veins in the stomach, thereby reducing the pressure in these vessels. In addition to the use of beta-blockers, there have been other interventions studied for primary prophylaxis of gastric varices. These include the use of endoscopic techniques such as band ligation and injection sclerotherapy, and the use of the cyanoacrylate glue.

Conditions

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Gastric Varices Bleeding Endoscopic Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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EUS-Guided Therapy of glue and coil + Non-selective Beta Blockers (Propanolol)

Participants in this arm will receive a daily oral dose of a non-selective beta blocker (Propanolol) and undergo EUS-guided therapy of glue and coil as described in Arms 1 and 2. Participants will be monitored for side effects, complications, and efficacy of both the medication and the procedure.

Group Type ACTIVE_COMPARATOR

EUS-Guided Therapy of Glue and Coil

Intervention Type PROCEDURE

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.

Non-Selective Beta Blockers (Propanolol)

Intervention Type DRUG

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.

EUS-Guided Therapy of Glue and Coil

Participants in this arm will undergo endoscopic ultrasound (EUS) to identify and target gastric varices. Under EUS guidance, a combination of glue and coil will be used to occlude the gastric varices. Participants will be monitored for complications and efficacy of the procedure

Group Type ACTIVE_COMPARATOR

EUS-Guided Therapy of Glue and Coil

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Non-Selective Beta Blockers (Propanolol)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Other Intervention Names

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Propanolol

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years or older
* Referred to St. Michael's Hospital (SMH) for esophagogastroduodenoscopy (EGD) screening for varices
* Patients with GOV-2 or IGV-1 varices with the size ≥ 10 mm

Exclusion Criteria

* Age \>75 and \< 18 years
* Pregnancy
* Contraindications to beta-blockers and cyanoacrylate injection
* Prior treatment for prevention of bleeding from patients on beta-blockers
* Hepatic encephalopathy grade III/IV
* Hepatorenal syndrome, hepatocellular carcinoma, presence of deep jaundice (serum bilirubin \>170 mmol/L)
* Cardiorespiratory failure
* Co-existing large oesophageal varices which require endoscopic intervention
* Child-Pugh C (score of 10-15 indicating decompensated disease)
* Presence of serious complications of liver cirrhosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samir C Grover, MD, MEd

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Kareem Khalaf, HBSc, MD

Role: STUDY_DIRECTOR

Unity Health Toronto

Nikko Gimpaya, HBSc, MEd

Role: STUDY_DIRECTOR

Unity Health Toronto

Other Identifiers

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23-066

Identifier Type: -

Identifier Source: org_study_id