Gastric Varices, Gastric Varices Bleeding, Portal Hypertension
Conditions
Keywords
Endoscopic ultrasound, EUS-guided therapy, Portal hypertension, Cyanoacrylate glue, Absorbable gelatin sponge, Gelfoam, Coil embolization, Variceal obliteration, Secondary prophylaxis
Brief summary
This study compares two endoscopic ultrasound-guided treatments for gastric varices, which are enlarged veins in the stomach that can bleed. Both treatments use small coils placed into the varix. One group will receive coils with cyanoacrylate medical glue, and the other group will receive coils with absorbable gelatin sponge. The purpose of the study is to determine whether absorbable gelatin sponge with coils is not worse than cyanoacrylate glue with coils for closing off gastric varices, and to compare safety outcomes. Participants will be randomly assigned to one of the two treatment groups. Participants and outcome assessors will not know which treatment was used, but the doctor performing the procedure will know. After the procedure, participants will be followed for up to 12 months. Follow-up may include clinical assessments, questionnaires about health and quality of life, CT imaging shortly after the procedure, and repeat endoscopic ultrasound assessments to evaluate whether the gastric varix has been successfully treated.
Detailed description
Gastric varices are enlarged veins in the stomach that occur in patients with portal hypertension and can cause serious bleeding. Endoscopic ultrasound-guided therapy allows direct visualization of the target varix, placement of embolization coils, delivery of an embolic material, and Doppler assessment of blood flow after treatment. Cyanoacrylate glue combined with coils is an established treatment approach for gastric varices. However, glue injection can be technically challenging and may be associated with complications such as embolization or equipment-related issues. Absorbable gelatin sponge, delivered as a slurry with coils, is an alternative approach that is used in clinical care and may avoid some of the practical limitations of glue. Comparative randomized data between these approaches are limited. This is a randomized, patient- and assessor-blinded, non-inferiority trial comparing endoscopic ultrasound-guided coil embolization with cyanoacrylate glue versus endoscopic ultrasound-guided coil embolization with absorbable gelatin sponge for the treatment of gastric varices. Eligible participants will be randomized in a 1:1 ratio after confirmation of eligibility and informed consent. Randomization will occur intra-procedurally before treatment. Participants assigned to the cyanoacrylate group will undergo endoscopic ultrasound-guided coil deployment followed by injection of cyanoacrylate glue mixed with Lipiodol. Participants assigned to the absorbable gelatin sponge group will undergo endoscopic ultrasound-guided coil deployment followed by injection of absorbable gelatin sponge slurry. In both groups, Doppler assessment will be used to evaluate blood flow in the target varix after treatment. Repeat coil and/or embolic material injection may be performed at the discretion of the treating endoscopist. Participants will be monitored after the procedure for complications, including bleeding and embolization. Follow-up includes CT imaging approximately 48 hours after the procedure, clinical and questionnaire-based follow-up at 1, 3, 6, and 12 months, and repeat endoscopic assessment with endoscopic ultrasound at approximately 3 months and 12 months. The primary endpoint is complete obliteration of the target gastric varix, assessed by absence of Doppler flow on follow-up endoscopic ultrasound at 3 months. Secondary and tertiary outcomes include immediate technical success, clinical success, rebleeding, adverse events, hospital admission, ICU admission, transfusion requirements, reintervention, length of stay, procedural technical difficulty, costs, and health-related quality of life.
Interventions
PROCEDUREEUS-Guided Coil Embolization With Cyanoacrylate Glue and Lipiodol
Endoscopic ultrasound-guided treatment of a gastric varix using coil deployment followed by injection of cyanoacrylate glue mixed with Lipiodol under direct visualization. The injection is flushed with sterile water. Repeat coil and/or glue injection may be performed at the discretion of the treating endoscopist. Doppler assessment is performed to assess eradication of flow in the treated gastric varix.
PROCEDUREEUS-Guided Coil Embolization With Absorbable Gelatin Sponge
Endoscopic ultrasound-guided treatment of a gastric varix using coil deployment followed by injection of absorbable gelatin sponge slurry under direct visualization. The slurry is flushed with sterile water. Repeat coil and/or absorbable gelatin sponge injection may be performed at the discretion of the treating endoscopist. Doppler assessment is performed to assess eradication of flow in the treated gastric varix.
Sponsors
Unity Health Toronto
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors will be masked to treatment allocation. The endoscopist performing the procedure will not be masked because of the nature of the interventions. Procedural details will not be disclosed to participants or independent outcome assessors, and blinded assessors will not have access to the procedural note or treatment allocation at the time of outcome assessment.
Intervention model description
Participants will be randomized in a 1:1 ratio to one of two parallel treatment arms: EUS-guided coil with cyanoacrylate glue and Lipiodol, or EUS-guided coil with absorbable gelatin sponge. Randomization will occur intra-procedurally after eligibility is confirmed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older. * Gastric varices deemed suitable for EUS-guided endoscopic treatment. * History of suspected gastric variceal bleeding or active gastric variceal bleeding, with treatment intended for secondary prophylaxis. * Ability to provide informed consent directly or through a substitute decision maker. * Willingness and ability to undergo clinical follow-up, EUS assessment, and CT imaging.
Exclusion criteria
* Inability or unwillingness to provide informed consent directly or through a substitute decision maker. * No gastric varix present, or gastric varix too small or not amenable to combination therapy. * Contraindication to therapeutic EUS or endoscopy. * Contraindication to any study material used in the assigned treatment arm. * Contraindication to contrast-enhanced CT, if not clinically manageable. * Inability to complete planned follow-up. * Pregnancy. * Any clinical situation in which the treating endoscopist determines that randomization would be unsafe or inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Obliteration of the Target Gastric Varix on EUS | 3 months post-intervention | Proportion of participants with complete obliteration of the target gastric varix, defined as cessation or absence of Doppler flow within the target varix on follow-up endoscopic ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Technical Success | During index procedure | Successful EUS-guided deployment of coil and assigned embolic material into the gastric varix with cessation of Doppler flow at the end of the procedure. |
| Short-Term Clinical Success | Up to 3 months post-intervention | Cessation of bleeding if present at baseline and/or absence of recurrent gastric variceal bleeding after the intervention. |
| Procedure-Related Adverse Events | From index procedure through 12 months | Rate and severity of procedure-related adverse events, categorized according to the ASGE Lexicon for endoscopic adverse events. |
| Long-Term Technical Success | 12 months post-intervention | Complete obliteration of the treated gastric varix on repeat EUS, defined as absence of Doppler flow in the treated target varix. |
| Long-Term Clinical Success | Up to 12 months post-intervention | Absence of recurrent gastric variceal bleeding and assessment of clinical durability after the intervention. |
Countries
Canada
Contacts
CONTACTKareem Khalaf, MD
CONTACTKatina Zheng, MD
PRINCIPAL_INVESTIGATORSunil Gupta, MD, PhD
Division of Gastroenterology, St. Michael's Hospital, Unity Health Toronto, University of Toronto, Toronto, Ontario, Canada
Outcome results
None listed