EUS-Guided Coil and Glue vs Glue Injection for Bleeding Gastric Varices in Cirrhosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorMedanta, The Medicity, India
About this trial
Gastric variceal bleeding is a life-threatening complication of portal hypertension in patients with cirrhosis and is associated with significant morbidity and mortality. Endoscopic cyanoacrylate glue injection is the current standard treatment; however, recurrent bleeding and procedure-related complications remain important concerns. Endoscopic ultrasound (EUS)-guided coil and cyanoacrylate glue injection has emerged as a promising alternative that may improve variceal obliteration and reduce rebleeding rates.
This prospective, randomized, open-label, parallel-group trial will compare EUS-guided coil and cyanoacrylate glue injection with conventional endoscopic cyanoacrylate glue injection in patients with cirrhosis presenting with bleeding gastric varices. A total of 158 participants will be randomized in a 1:1 ratio to either treatment arm. The primary outcome is all-cause rebleeding at 12 months. Secondary outcomes include technical success, early and late rebleeding, number of treatment sessions required for variceal obliteration, glue volume used, procedure-related adverse events, hepatic decompensation, duration of hospital stay, cost of treatment, and mortality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years
Confirmed diagnosis of liver cirrhosis with portal hypertension
Patients presenting with suspected bleed from cardio-fundal varices, specifically classified as gastroesophageal varices type-2 (GOV-2) or isolated gastric varices type-1 (IGV-1)
Disqualifiers
Patients experiencing bleeding from esophageal varices (EV) or gastroesophageal varices type-1 (GOV-1) or IGV2
Patients with non-cirrhotic portal hypertension
Active spurt of blood noted from gastric varices seen on endoscopy
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
EUS-guided Coil and Cyanoacrylate Glue Injection
Procedure/SurgeryEndoscopic ultrasound (EUS)-guided treatment of gastric varices in which embolization coil(s) are deployed into the target varix through a 19-gauge EUS needle, followed by injection of cyanoacrylate glue and a 5% dextrose flush. The procedure is performed under Doppler guidance to achieve complete obliteration of blood flow within the treated varix. Additional EUS-guided treatment may be performed during follow-up until complete variceal obliteration is achieved.
Endoscopic Cyanoacrylate Glue Injection
Procedure/SurgeryConventional endoscopic injection of cyanoacrylate glue into gastric varices using a standard sclerotherapy needle. Following endoscopic localization of the target varix, cyanoacrylate glue is injected to achieve variceal obliteration. Technical success is confirmed by hardening of the treated varix on gentle endoscopic probing. Additional endoscopic glue injection may be performed during follow-up until complete variceal obliteration is achieved.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: EUS-guided Coil and Glue InjectionExperimental treatment 1 intervention
Group B: Endoscopic Glue InjectionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
All cause rebleeding rate
Time frame
Upto 12 months from index interventionSecondary outcomes
1
Technical Success
Time frame
During the index procedure2
Early Rebleeding
Time frame
Up to 6 weeks after the index intervention3
Late Rebleeding
Time frame
From 6 weeks to 12 months after the index intervention4
Number of Treatment Sessions Required for Variceal Obliteration
Time frame
Up to 12 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medanta, The Medicity, India
Lead sponsor
Orlando Health, Inc.
Collaborator
Source ClinicalTrials.gov