[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658633":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":49,"studyPopulation":11,"armGroups":50,"interventions":63,"overallOfficials":11,"centralContacts":73,"locations":79,"responsibleParty":118,"collaborators":121,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":11,"eligibilityCriteria":130,"healthyVolunteers":126,"sex":131,"minAge":132,"maxAge":11,"enrollmentInfo":133,"targetDuration":11,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":101,"whyStopped":11,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Medanta, The Medicity, India","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"All cause rebleeding rate",null,"Upto 12 months from index intervention",[14,17,20,23,26,30,33,36,39],{"measure":15,"description":11,"timeFrame":16},"Technical Success","During the index procedure",{"measure":18,"description":11,"timeFrame":19},"Early Rebleeding","Up to 6 weeks after the index intervention",{"measure":21,"description":11,"timeFrame":22},"Late Rebleeding","From 6 weeks to 12 months after the index intervention",{"measure":24,"description":11,"timeFrame":25},"Number of Treatment Sessions Required for Variceal Obliteration","Up to 12 months after randomization",{"measure":27,"description":28,"timeFrame":29},"Cyanoacrylate Glue Volume Utilized","To compare the total volume of cyanoacrylate glue required to achieve complete gastric variceal obliteration in each treatment group.","Up to complete variceal obliteration",{"measure":31,"description":32,"timeFrame":25},"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.",{"measure":34,"description":35,"timeFrame":25},"Hepatic Decompensation","To compare the incidence of hepatic decompensation events including ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, and recurrent variceal bleeding.",{"measure":37,"description":38,"timeFrame":25},"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.",{"measure":40,"description":41,"timeFrame":25},"Mortality","To compare all-cause mortality between the two treatment groups during follow-up.",{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":11,"timePerspective":11,"maskingInfo":47},"RANDOMIZED","PARALLEL","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.","TREATMENT",{"masking":48,"maskingDescription":11,"whoMasked":11},"NONE","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.\n\nEndoscopic 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.\n\nThis 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.\n\nThe 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.\n\nParticipants 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.",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"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.",[56],"Procedure: EUS-guided Coil and Cyanoacrylate Glue Injection",{"label":58,"type":59,"description":60,"interventionNames":61},"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.",[62],"Procedure: Endoscopic Cyanoacrylate Glue Injection",[64,69],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":11},"PROCEDURE","EUS-guided Coil and Cyanoacrylate Glue Injection","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.",[52],{"type":65,"name":70,"description":71,"armGroupLabels":72,"otherNames":11},"Endoscopic Cyanoacrylate Glue Injection","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.",[58],[74],{"name":75,"role":76,"phone":77,"phoneExt":11,"email":78},"Rajesh Puri, MD","CONTACT","+919999411125","purirajesh1969@gmail.com",[80,99],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Orlando Health Orlando Regional Medical Center","NOT_YET_RECRUITING","Orlando","Florida","32806","United States","US",{"type":89,"coordinates":90},"Point",[91,92],-81.37924,28.53834,{"lat":92,"lon":91},[95],{"name":96,"role":76,"phone":97,"phoneExt":11,"email":98},"Dr shyam, MD","321-841-3742","Shyam.Varadarajulu@orlandohealth.com",{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Medanta The Medicity","RECRUITING","Gurgaon","Haryana","122001","India","IN",{"type":89,"coordinates":108},[109,110],77.02635,28.4601,{"lat":110,"lon":109},[113,115,116],{"name":75,"role":76,"phone":114,"phoneExt":11,"email":78},"09999411125",{"name":11,"role":76,"phone":11,"phoneExt":11,"email":78},{"name":75,"role":117,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":117,"investigatorFullName":119,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Rajesh Puri","Vice Chairman, Institute of Digestive and Hepatobiliary Sciences",[122],{"name":123,"class":6},"Orlando Health, Inc.","100658633","eus-guided-coil-and-glue-vs-glue-injection-for-bleeding-gastric-varices-in-cirrhosis-100658633",false,"NCT07855913","EUS-Guided Coil and Glue vs Glue Injection for Bleeding Gastric Varices in Cirrhosis","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","Inclusion Criteria:\n\n* Age \\> 18 years\n* Confirmed diagnosis of liver cirrhosis with portal hypertension\n* 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)\n\nExclusion Criteria:\n\n* Patients experiencing bleeding from esophageal varices (EV) or gastroesophageal varices type-1 (GOV-1) or IGV2\n* Patients with non-cirrhotic portal hypertension\n* Active spurt of blood noted from gastric varices seen on endoscopy\n* Pregnancy\n* Patients with refractory shock\n* Sepsis\u002FACLF\n* Platelet count \\\u003C 50,000 \u002FmL and International Normalized Rate (INR) \\> 2.0\n* Contraindication to endoscopy\n* Not willing to provide consent","ALL","19 Years",{"count":134,"type":135},110,"ESTIMATED","INTERVENTIONAL",[138],"NA","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.\n\nThis 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.",[141,142],"Gastric Varices Bleeding","Cirrhosis",[144,145,146,147,148,149],"coil and glue","Endoscopic ultrasound","endoscopic glue injection","Guided coil and glue injection","cirrhosis","gastric variceal bleed","2026-10-05",{"date":152,"type":153},"2026-10-06","ACTUAL",{"date":155,"type":135},"2026-09",{"date":157,"type":135},"2028-06",{"name":5,"class":6},2]