Primary Prevention of Gastric Varices Bleed

NCT05859009 | Withdrawn DMC

• 1 other identifier: 23-066
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (6)

• Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1

  \- incidence of bleeding during the follow-up

  3 months

• Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1

  -regression of gastric varices

  3 months

• Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1

  \- incidence of bleeding during the follow-up

  6 months

• Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1

  -regression of gastric varices

  6 months

• Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1

  \- incidence of bleeding during the follow-up

  9 months

• Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1

  -regression of gastric varices

  9 months

Secondary Outcomes (3)

• Estimation if any of the study arms is better for regression in size of varix

  3 months

• Estimation if any of the study arms is better for regression in size of varix

  6 months

• Estimation if any of the study arms is better for regression in size of varix

  9 months

Other Outcomes (3)

• Safety of the procedure

  - Follow-up visit after 3 months

• Safety of the procedure

  - Follow-up visit after 6 months

• Safety of the procedure

  - Follow-up visit after 9 months

Study Arms (3)

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

ACTIVE COMPARATOR

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.

Procedure: EUS-Guided Therapy of Glue and Coil; Drug: Non-Selective Beta Blockers (Propanolol)

EUS-Guided Therapy of Glue and Coil

ACTIVE COMPARATOR

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

Procedure: EUS-Guided Therapy of Glue and Coil

Non-Selective Beta Blockers (Propanolol)

ACTIVE COMPARATOR

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.

Drug: Non-Selective Beta Blockers (Propanolol)

Interventions

EUS-Guided Therapy of Glue and Coil 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.

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

Non-Selective Beta Blockers (Propanolol) 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.

Also known as: Propanolol

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

MeSH Terms

Interventions

p80-coilin; Propranolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Samir C Grover, MD, MEd

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Kareem Khalaf, HBSc, MD

  Unity Health Toronto

  STUDY DIRECTOR

• Nikko Gimpaya, HBSc, MEd

  Unity Health Toronto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 15, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share