Gastric Varices BleedingNCT07855913
EUS-Guided Coil and Glue vs Glue Injection for Bleeding Gastric Varices in Cirrhosis
A study testing EUS-guided Coil and Cyanoacrylate Glue Injection and Endoscopic Cyanoacrylate Glue Injection in people with Gastric Varices Bleeding and Cirrhosis, run by Medanta, The Medicity, India at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Varices Bleeding, Cirrhosis
- What is being tested?
- EUS-guided Coil and Cyanoacrylate Glue Injection and Endoscopic Cyanoacrylate Glue Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
- Patients with refractory shock
- Sepsis/ACLF
Show all 9Show fewer
- Platelet count < 50,000 /mL and International Normalized Rate (INR) > 2.0
- Contraindication to endoscopy
- Not willing to provide consent
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
Orlando Health Orlando Regional Medical Center
Orlando, Florida, 32806
Dr shyam, MD, 321-841-3742, Shyam.Varadarajulu@orlandohealth.com
India1 site, 1 recruiting
- Recruiting
Medanta The Medicity
Gurgaon, Haryana, 122001
Rajesh Puri, MD, 09999411125, purirajesh1969@gmail.com
purirajesh1969@gmail.com
About this study
Official title: Endoscopic Ultrasound-Guided Coil and Glue Injection Versus Endoscopic Glue Injection in Patients With Cirrhosis and Gastric Variceal Bleed: An Open Label Randomized Controlled 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.
Read the detailed description
Gastric varices (GV) are a major complication of portal hypertension in patients with cirrhosis and account for approximately 10-30% of all variceal bleeding episodes. Although less common than esophageal variceal bleeding, gastric variceal hemorrhage is often more severe and is associated with higher transfusion requirements, increased risk of rebleeding, and significant mortality. Endoscopic injection of cyanoacrylate (CYA) glue is currently the standard endoscopic treatment for bleeding gastric varices and has demonstrated high rates of initial hemostasis. However, recurrent bleeding, incomplete obliteration of varices, glue extrusion, embolic complications, and the need for repeated treatment sessions remain important limitations.
Endoscopic ultrasound (EUS)-guided therapy has emerged as an alternative approach for the management of gastric varices. EUS enables precise visualization of gastric varices and their feeding vessels, facilitating targeted treatment. The combination of EUS-guided coil deployment and cyanoacrylate glue injection may improve variceal obliteration by providing a scaffold for glue retention, reducing glue requirements, and minimizing the risk of embolization. Several observational studies and meta-analyses have suggested that EUS-guided coil and glue therapy may achieve superior variceal obliteration and lower rebleeding rates compared with conventional endoscopic glue injection. However, high-quality randomized controlled trials comparing these approaches remain limited.
This study is a prospective, randomized, open-label, parallel-group clinical trial designed to compare the efficacy and safety of 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 eligible participants will be enrolled and randomized in a 1:1 ratio to one of two treatment groups. Participants assigned to the intervention arm will undergo EUS-guided deployment of embolization coils followed by cyanoacrylate glue injection into the target gastric varix. Participants assigned to the comparator arm will undergo direct endoscopic cyanoacrylate glue injection according to standard practice. Follow-up endoscopic or EUS assessments will be performed as per protocol, and repeat treatment sessions will be undertaken when necessary until complete obliteration of the varices is achieved.
The primary objective of the study is to compare all-cause rebleeding at 12 months between the two treatment strategies. Secondary objectives include assessment of technical success, early and late rebleeding, number of treatment sessions required for complete variceal obliteration, volume of cyanoacrylate glue utilized, procedure-related adverse events, hepatic decompensation, duration of hospital stay, treatment-related costs, and mortality.
Participants will be followed for a period of 12 months after randomization. The findings of this study are expected to provide robust evidence regarding the optimal endoscopic management strategy for bleeding gastric varices and may help guide future clinical practice in patients with portal hypertension and cirrhosis.
- Conditions
- Gastric Varices Bleeding, Cirrhosis
- Being tested
- EUS-guided Coil and Cyanoacrylate Glue Injection, Endoscopic Cyanoacrylate Glue Injection
- Keywords
- coil and glue, Endoscopic ultrasound, endoscopic glue injection, Guided coil and glue injection, cirrhosis, gastric variceal bleed
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided Coil and Cyanoacrylate Glue InjectionProcedure or surgery
Endoscopic 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 InjectionProcedure or surgery
Conventional 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.
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided Coil and Glue Injection | Experimental | Participants randomized to this arm will undergo endoscopic ultrasound (EUS)-guided treatment of bleeding gastric varices using embolization coils followed by cyanoacrylate glue injection. Additional EUS-guided treatment will be performed during follow-up if residual Doppler flow is present until complete variceal obliteration is achieved. Participants will undergo scheduled follow-up for 12 months with clinical assessment, EUS surveillance, and laboratory investigations. Receives: Procedure: EUS-guided Coil and Cyanoacrylate Glue Injection |
| Endoscopic Glue Injection | Active comparator | Participants randomized to this arm will undergo conventional endoscopic cyanoacrylate glue injection for treatment of bleeding gastric varices. Additional endoscopic glue injection will be performed during follow-up if residual varices are present until complete variceal obliteration is achieved. Participants will undergo scheduled follow-up for 12 months with clinical assessment, surveillance endoscopy, and laboratory investigations. Receives: Procedure: Endoscopic Cyanoacrylate Glue Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause rebleeding rate
Measured: Upto 12 months from index intervention
Secondary outcomes (9)
Technical Success
Measured: During the index procedure
Early Rebleeding
Measured: Up to 6 weeks after the index intervention
Late Rebleeding
Measured: From 6 weeks to 12 months after the index intervention
Number of Treatment Sessions Required for Variceal Obliteration
Measured: Up to 12 months after randomization
Cyanoacrylate Glue Volume Utilized
To compare the total volume of cyanoacrylate glue required to achieve complete gastric variceal obliteration in each treatment group.
Measured: Up to complete variceal obliteration
Procedure-related Adverse Events
To compare the incidence of procedure-related adverse events including embolization, bleeding, infection, perforation, abdominal pain, fever, and other treatment-related complications.
Measured: Up to 12 months after randomization
Hepatic Decompensation
To compare the incidence of hepatic decompensation events including ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, and recurrent variceal bleeding.
Measured: Up to 12 months after randomization
Cost analysis
To compare the overall healthcare costs associated with EUS-guided coil and glue injection versus endoscopic cyanoacrylate glue injection, including procedural and hospitalization costs.
Measured: Up to 12 months after randomization
Mortality
To compare all-cause mortality between the two treatment groups during follow-up.
Measured: Up to 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gastric Varices BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, open-label, parallel-group trial. Eligible patients with cirrhosis and bleeding gastric varices will be allocated in a 1:1 ratio to receive either EUS-guided coil plus cyanoacrylate glue injection or direct endoscopic cyanoacrylate glue injection. Participants will remain in the assigned intervention group for the duration of the study, and efficacy and safety outcomes will be assessed prospectively over a 12-month follow-up period.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medanta, The Medicity, India
- Sponsor type
- University, hospital or other
- Collaborators
- Orlando Health, Inc.
- Responsible party
- Principal investigator, Rajesh Puri, Medanta, The Medicity, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855913
- Sponsor's protocol ID
- MED-END-GV-2026-001
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jhajharia A, Yadav S, Singh S, Ashdhir P, Nijhawan S. Endoscopic ultrasonography-guided coil embolization and cyanoacrylate injection versus cyanoacrylate injection alone for gastric varices: a randomized comparative study. Endoscopy. 2025 Feb;57(2):107-115. doi: 10.1055/a-2408-6905. Epub 2024 Sep 18.
PubMed 39293480Florencio de Mesquita C, Antunes VLJ, Milioli NJ, Fernandes MV, Correa TL, Martins OC, Chavan R, Baraldo S. EUS-guided coiling plus glue injection compared with endoscopic glue injection alone in endoscopic treatment for gastric varices: a systematic review and meta-analysis. Gastrointest Endosc. 2025 Feb;101(2):331-340.e8. doi: 10.1016/j.gie.2024.10.005. Epub 2024 Oct 9.
PubMed 39389435Jamwal KD, Padhan RK, Sharma A, Sharma MK. Endoscopic ultrasound-guided coiling and glue is safe and superior to endoscopic glue injection in gastric varices with severe liver disease: a retrospective case control study. Clin Endosc. 2023 Jan;56(1):65-74. doi: 10.5946/ce.2021.119. Epub 2023 Jan 3.
PubMed 36594180Thiruvengadam SS, Sedarat A. The Role of Endoscopic Ultrasound (EUS) in the Management of Gastric Varices. Curr Gastroenterol Rep. 2021 Jan 2;23(1):1. doi: 10.1007/s11894-020-00801-2.
PubMed 33389241Cheng LF, Wang ZQ, Li CZ, Lin W, Yeo AE, Jin B. Low incidence of complications from endoscopic gastric variceal obturation with butyl cyanoacrylate. Clin Gastroenterol Hepatol. 2010 Sep;8(9):760-6. doi: 10.1016/j.cgh.2010.05.019. Epub 2010 May 31.
PubMed 20621678Soehendra N, Nam VC, Grimm H, Kempeneers I. Endoscopic obliteration of large esophagogastric varices with bucrylate. Endoscopy. 1986 Jan;18(1):25-6. doi: 10.1055/s-2007-1013014.
PubMed 3512261Vine LJ, Subhani M, Acevedo JG. Update on management of gastric varices. World J Hepatol. 2019 Mar 27;11(3):250-260. doi: 10.4254/wjh.v11.i3.250.
PubMed 30967903Mohan BP, Chandan S, Khan SR, Kassab LL, Trakroo S, Ponnada S, Asokkumar R, Adler DG. Efficacy and safety of endoscopic ultrasound-guided therapy versus direct endoscopic glue injection therapy for gastric varices: systematic review and meta-analysis. Endoscopy. 2020 Apr;52(4):259-267. doi: 10.1055/a-1098-1817. Epub 2020 Feb 6.
PubMed 32028533Weilert F, Binmoeller KF. Endoscopic management of gastric variceal bleeding. Gastroenterol Clin North Am. 2014 Dec;43(4):807-18. doi: 10.1016/j.gtc.2014.08.010. Epub 2014 Sep 12.
PubMed 25440927Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
PubMed 27786365
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-Guided Coil and Glue Injection Versus Endoscopic Glue Injection in Patients With Cirrhosis and Gastric Variceal Bleed: An Open Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07855913
- Acronym / sponsor ID
- MED-END-GV-2026-001
- Conditions
- Gastric Varices Bleeding, Cirrhosis
- Keywords
- coil and glue, Endoscopic ultrasound, endoscopic glue injection, Guided coil and glue injection, cirrhosis, gastric variceal bleed
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Medanta, The Medicity, IndiaUniversity, hospital or other
- Collaborators
- Orlando Health, Inc.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Gastric varices (GV) are a major complication of portal hypertension in patients with cirrhosis and account for approximately 10-30% of all variceal bleeding episodes. Although less common than esophageal variceal bleeding, gastric variceal hemorrhage is often more severe and is associated with higher transfusion requirements, increased risk of rebleeding, and significant mortality. Endoscopic injection of cyanoacrylate (CYA) glue is currently the standard endoscopic treatment for bleeding gastric varices and has demonstrated high rates of initial hemostasis. However, recurrent bleeding, incomplete obliteration of varices, glue extrusion, embolic complications, and the need for repeated treatment sessions remain important limitations.
Endoscopic ultrasound (EUS)-guided therapy has emerged as an alternative approach for the management of gastric varices. EUS enables precise visualization of gastric varices and their feeding vessels, facilitating targeted treatment. The combination of EUS-guided coil deployment and cyanoacrylate glue injection may improve variceal obliteration by providing a scaffold for glue retention, reducing glue requirements, and minimizing the risk of embolization. Several observational studies and meta-analyses have suggested that EUS-guided coil and glue therapy may achieve superior variceal obliteration and lower rebleeding rates compared with conventional endoscopic glue injection. However, high-quality randomized controlled trials comparing these approaches remain limited.
This study is a prospective, randomized, open-label, parallel-group clinical trial designed to compare the efficacy and safety of 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 eligible participants will be enrolled and randomized in a 1:1 ratio to one of two treatment groups. Participants assigned to the intervention arm will undergo EUS-guided deployment of embolization coils followed by cyanoacrylate glue injection into the target gastric varix. Participants assigned to the comparator arm will undergo direct endoscopic cyanoacrylate glue injection according to standard practice. Follow-up endoscopic or EUS assessments will be performed as per protocol, and repeat treatment sessions will be undertaken when necessary until complete obliteration of the varices is achieved.
The primary objective of the study is to compare all-cause rebleeding at 12 months between the two treatment strategies. Secondary objectives include assessment of technical success, early and late rebleeding, number of treatment sessions required for complete variceal obliteration, volume of cyanoacrylate glue utilized, procedure-related adverse events, hepatic decompensation, duration of hospital stay, treatment-related costs, and mortality.
Participants will be followed for a period of 12 months after randomization. The findings of this study are expected to provide robust evidence regarding the optimal endoscopic management strategy for bleeding gastric varices and may help guide future clinical practice in patients with portal hypertension and cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, open-label, parallel-group trial. Eligible patients with cirrhosis and bleeding gastric varices will be allocated in a 1:1 ratio to receive either EUS-guided coil plus cyanoacrylate glue injection or direct endoscopic cyanoacrylate glue injection. Participants will remain in the assigned intervention group for the duration of the study, and efficacy and safety outcomes will be assessed prospectively over a 12-month follow-up period.
| Arm | Type | Receives |
|---|---|---|
| EUS-guided Coil and Glue Injection | Experimental | Procedure: EUS-guided Coil and Cyanoacrylate Glue InjectionParticipants randomized to this arm will undergo endoscopic ultrasound (EUS)-guided treatment of bleeding gastric varices using embolization coils followed by cyanoacrylate glue injection. Additional EUS-guided treatment will be performed during follow-up if residual Doppler flow is present until complete variceal obliteration is achieved. Participants will undergo scheduled follow-up for 12 months with clinical assessment, EUS surveillance, and laboratory investigations. |
| Endoscopic Glue Injection | Active comparator | Procedure: Endoscopic Cyanoacrylate Glue InjectionParticipants randomized to this arm will undergo conventional endoscopic cyanoacrylate glue injection for treatment of bleeding gastric varices. Additional endoscopic glue injection will be performed during follow-up if residual varices are present until complete variceal obliteration is achieved. Participants will undergo scheduled follow-up for 12 months with clinical assessment, surveillance endoscopy, and laboratory investigations. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
- Patients with refractory shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-guided Coil and Cyanoacrylate Glue InjectionEndoscopic 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. | Procedure or surgery | EUS-guided Coil and Glue Injection |
| Endoscopic Cyanoacrylate Glue InjectionConventional 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. | Procedure or surgery | Endoscopic Glue Injection |
Primary outcome
All cause rebleeding rate
Time frame: Upto 12 months from index intervention
9 secondary outcomes
Technical Success
Time frame: During the index procedure
Early Rebleeding
Time frame: Up to 6 weeks after the index intervention
Late Rebleeding
Time frame: From 6 weeks to 12 months after the index intervention
Number of Treatment Sessions Required for Variceal Obliteration
Time frame: Up to 12 months after randomization
Cyanoacrylate Glue Volume Utilized
Time frame: Up to complete variceal obliteration
Procedure-related Adverse Events
Time frame: Up to 12 months after randomization
Hepatic Decompensation
Time frame: Up to 12 months after randomization
Cost analysis
Time frame: Up to 12 months after randomization
Mortality
Time frame: Up to 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 39293480Jhajharia A, Yadav S, Singh S, Ashdhir P, Nijhawan S. Endoscopic ultrasonography-guided coil embolization and cyanoacrylate injection versus cyanoacrylate injection alone for gastric varices: a randomized comparative study. Endoscopy. 2025 Feb;57(2):107-115. doi: 10.1055/a-2408-6905. Epub 2024 Sep 18.
- Background: PubMed 39389435Florencio de Mesquita C, Antunes VLJ, Milioli NJ, Fernandes MV, Correa TL, Martins OC, Chavan R, Baraldo S. EUS-guided coiling plus glue injection compared with endoscopic glue injection alone in endoscopic treatment for gastric varices: a systematic review and meta-analysis. Gastrointest Endosc. 2025 Feb;101(2):331-340.e8. doi: 10.1016/j.gie.2024.10.005. Epub 2024 Oct 9.
- Background: PubMed 36594180Jamwal KD, Padhan RK, Sharma A, Sharma MK. Endoscopic ultrasound-guided coiling and glue is safe and superior to endoscopic glue injection in gastric varices with severe liver disease: a retrospective case control study. Clin Endosc. 2023 Jan;56(1):65-74. doi: 10.5946/ce.2021.119. Epub 2023 Jan 3.
- Background: PubMed 33389241Thiruvengadam SS, Sedarat A. The Role of Endoscopic Ultrasound (EUS) in the Management of Gastric Varices. Curr Gastroenterol Rep. 2021 Jan 2;23(1):1. doi: 10.1007/s11894-020-00801-2.
- Background: PubMed 20621678Cheng LF, Wang ZQ, Li CZ, Lin W, Yeo AE, Jin B. Low incidence of complications from endoscopic gastric variceal obturation with butyl cyanoacrylate. Clin Gastroenterol Hepatol. 2010 Sep;8(9):760-6. doi: 10.1016/j.cgh.2010.05.019. Epub 2010 May 31.
- Background: PubMed 3512261Soehendra N, Nam VC, Grimm H, Kempeneers I. Endoscopic obliteration of large esophagogastric varices with bucrylate. Endoscopy. 1986 Jan;18(1):25-6. doi: 10.1055/s-2007-1013014.
- Background: PubMed 30967903Vine LJ, Subhani M, Acevedo JG. Update on management of gastric varices. World J Hepatol. 2019 Mar 27;11(3):250-260. doi: 10.4254/wjh.v11.i3.250.
- Background: PubMed 32028533Mohan BP, Chandan S, Khan SR, Kassab LL, Trakroo S, Ponnada S, Asokkumar R, Adler DG. Efficacy and safety of endoscopic ultrasound-guided therapy versus direct endoscopic glue injection therapy for gastric varices: systematic review and meta-analysis. Endoscopy. 2020 Apr;52(4):259-267. doi: 10.1055/a-1098-1817. Epub 2020 Feb 6.
- Background: PubMed 25440927Weilert F, Binmoeller KF. Endoscopic management of gastric variceal bleeding. Gastroenterol Clin North Am. 2014 Dec;43(4):807-18. doi: 10.1016/j.gtc.2014.08.010. Epub 2014 Sep 12.
- Background: PubMed 27786365Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided Coil and Cyanoacrylate Glue Injection and Endoscopic Cyanoacrylate Glue Injection in people with Gastric Varices Bleeding and Cirrhosis, run by Medanta, The Medicity, India at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajesh Puri, MD (+919999411125, purirajesh1969@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause rebleeding rate (time frame: Upto 12 months from index intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07855913, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.