Cyanoacrylate Glue Versus Absorbable Gelatin Sponge for Gastric Varices
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
EUS-Guided Coil Embolization With Cyanoacrylate Glue and Lipiodol
Procedure/SurgeryEndoscopic 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.
EUS-Guided Coil Embolization With Absorbable Gelatin Sponge
Procedure/SurgeryEndoscopic 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.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Cyanoacrylate Glue + Lipiodol + CoilActive comparator 1 intervention
Group B: Absorbable Gelatin Sponge + CoilExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete Obliteration of the Target Gastric Varix on EUS
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.
Time frame
3 months post-interventionSecondary outcomes
1
Immediate Technical Success
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.
Time frame
During index procedure2
Short-Term Clinical Success
Cessation of bleeding if present at baseline and/or absence of recurrent gastric variceal bleeding after the intervention.
Time frame
Up to 3 months post-intervention3
Procedure-Related Adverse Events
Rate and severity of procedure-related adverse events, categorized according to the ASGE Lexicon for endoscopic adverse events.
Time frame
From index procedure through 12 months4
Long-Term Technical Success
Complete obliteration of the treated gastric varix on repeat EUS, defined as absence of Doppler flow in the treated target varix.
Time frame
12 months post-interventionOther outcomes
1
Transfusion Requirements
Number of blood product transfusions required after the intervention.
Time frame
From index procedure through 12 months2
Rebleeding
Occurrence of recurrent gastric variceal bleeding after the index intervention.
Time frame
From index procedure through 12 months3
Hospital Length of Stay
Length of hospital stay associated with the index presentation and intervention.
Time frame
From index admission up to 30 days4
ICU Admission
Occurrence of ICU admission after the intervention.
Time frame
From index procedure through 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Unity Health Toronto
Lead sponsor
University of Toronto
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: