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Primary Prevention of Gastric Varices Bleed

Primary Purpose

Gastric Varices Bleeding, Endoscopic Ultrasound

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EUS-Guided Therapy of Glue and Coil
Non-Selective Beta Blockers (Propanolol)
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Varices Bleeding

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

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

    EUS-Guided Therapy of Glue and Coil

    Non-Selective Beta Blockers (Propanolol)

    Arm Description

    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.

    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

    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.

    Outcomes

    Primary Outcome Measures

    Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1
    - incidence of bleeding during the follow-up
    Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1
    -regression of gastric varices
    Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1
    - incidence of bleeding during the follow-up
    Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1
    -regression of gastric varices
    Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1
    - incidence of bleeding during the follow-up
    Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1
    -regression of gastric varices

    Secondary Outcome Measures

    Estimation if any of the study arms is better for regression in size of varix
    Assessing Size of Varix (mm)
    Estimation if any of the study arms is better for regression in size of varix
    Assessing Size of Varix (mm)
    Estimation if any of the study arms is better for regression in size of varix
    Assessing Size of Varix (mm)

    Full Information

    First Posted
    March 27, 2023
    Last Updated
    May 25, 2023
    Sponsor
    Unity Health Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05859009
    Brief Title
    Primary Prevention of Gastric Varices Bleed
    Official Title
    EUS-guided Therapy vs Non-selective Beta Blocker for the Primary Prophylaxis of Gastric Varices Bleed: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2025 (Anticipated)
    Study Completion Date
    July 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Unity Health Toronto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Varices Bleeding, Endoscopic Ultrasound

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EUS-Guided Therapy of glue and coil + Non-selective Beta Blockers (Propanolol)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    EUS-Guided Therapy of Glue and Coil
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Non-Selective Beta Blockers (Propanolol)
    Arm Type
    Active Comparator
    Arm Description
    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
    Procedure
    Intervention Name(s)
    EUS-Guided Therapy of Glue and Coil
    Intervention Description
    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
    Drug
    Intervention Name(s)
    Non-Selective Beta Blockers (Propanolol)
    Other Intervention Name(s)
    Propanolol
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1
    Description
    - incidence of bleeding during the follow-up
    Time Frame
    3 months
    Title
    Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1
    Description
    -regression of gastric varices
    Time Frame
    3 months
    Title
    Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1
    Description
    - incidence of bleeding during the follow-up
    Time Frame
    6 months
    Title
    Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1
    Description
    -regression of gastric varices
    Time Frame
    6 months
    Title
    Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1
    Description
    - incidence of bleeding during the follow-up
    Time Frame
    9 months
    Title
    Assessment of NSBB (Propanolol), EUS-guided combined therapy (coils + glue) of GOV-2 and IGV-1
    Description
    -regression of gastric varices
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    Estimation if any of the study arms is better for regression in size of varix
    Description
    Assessing Size of Varix (mm)
    Time Frame
    3 months
    Title
    Estimation if any of the study arms is better for regression in size of varix
    Description
    Assessing Size of Varix (mm)
    Time Frame
    6 months
    Title
    Estimation if any of the study arms is better for regression in size of varix
    Description
    Assessing Size of Varix (mm)
    Time Frame
    9 months
    Other Pre-specified Outcome Measures:
    Title
    Safety of the procedure
    Description
    -Adverse Event (AE) rate for both methods
    Time Frame
    - Follow-up visit after 3 months
    Title
    Safety of the procedure
    Description
    -AE rate for both methods
    Time Frame
    - Follow-up visit after 6 months
    Title
    Safety of the procedure
    Description
    -AE rate for both methods
    Time Frame
    - Follow-up visit after 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Katarzyna M Pawlak, MD, PhD
    Phone
    41636040000
    Ext
    77537
    Email
    pawlakatarzyna@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Samir C Grover, MD, MEd
    Organizational Affiliation
    Unity Health Toronto
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kareem Khalaf, HBSc, MD
    Organizational Affiliation
    Unity Health Toronto
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Nikko Gimpaya, HBSc, MEd
    Organizational Affiliation
    Unity Health Toronto
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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