EUS-Guided Coil and Glue vs Glue Injection for Bleeding Gastric Varices in Cirrhosis

NCT07855913 | Recruiting

• 1 other identifier: MED-END-GV-2026-001
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 2

Brief 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 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.

Conditions

Gastric Varices Bleeding; Cirrhosis

Keywords

coil and glue; Endoscopic ultrasound; endoscopic glue injection; Guided coil and glue injection; cirrhosis; gastric variceal bleed

Outcome Measures

Primary Outcomes (1)

• All cause rebleeding rate

  Upto 12 months from index intervention

Secondary Outcomes (9)

• Technical Success

  During the index procedure

• Early Rebleeding

  Up to 6 weeks after the index intervention

• Late Rebleeding

  From 6 weeks to 12 months after the index intervention

• Number of Treatment Sessions Required for Variceal Obliteration

  Up to 12 months after randomization

• Cyanoacrylate Glue Volume Utilized

  Up to complete variceal obliteration

Study Arms (2)

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.

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.

Procedure: Endoscopic Cyanoacrylate Glue Injection

Interventions

EUS-guided Coil and Cyanoacrylate Glue Injection PROCEDURE

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.

EUS-guided Coil and Glue Injection

Endoscopic Cyanoacrylate Glue Injection PROCEDURE

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.

Endoscopic Glue Injection

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Platelet count \< 50,000 /mL and International Normalized Rate (INR) \> 2.0
• Contraindication to endoscopy
• Not willing to provide consent

Sponsors & Collaborators

• Medanta, The Medicity, India: lead
• Orlando Health, Inc.: collaborator

Study Sites (2)

Orlando Health Orlando Regional Medical Center

Orlando, Florida, 32806, United States

NOT YET RECRUITING

Medanta The Medicity

Gurgaon, Haryana, 122001, India

RECRUITING

Related Publications (10)

• 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.

  PMID: 39293480 BACKGROUND

• Florencio 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.

  PMID: 39389435 BACKGROUND

• Jamwal 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.

  PMID: 36594180 BACKGROUND

• Thiruvengadam 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.

  PMID: 33389241 BACKGROUND

• Cheng 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.

  PMID: 20621678 BACKGROUND

• Soehendra 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.

  PMID: 3512261 BACKGROUND

• Vine 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.

  PMID: 30967903 BACKGROUND

• Mohan 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.

  PMID: 32028533 BACKGROUND

• Weilert 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.

  PMID: 25440927 BACKGROUND

• Garcia-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.

  PMID: 27786365 BACKGROUND

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rajesh Puri, MD

CONTACT

+919999411125; purirajesh1969@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman, Institute of Digestive and Hepatobiliary Sciences

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: October 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IN (1)