Esophageal Varices

12

Review clinical trials related to Esophageal Varices. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Underdilated VCX-TIPS Versus EVL Plus NSBB for Secondary Prophylaxis of Variceal Bleeding in Cirrhosis

Variceal bleeding is a major complication of portal hypertension in patients with cirrhosis and is associated with substantial risks of rebleeding and death. Current guidelines recommend endoscopic variceal ligation combined with nonselective beta-blockers as standard secondary prophylaxis for esophageal variceal bleeding and type 1 gastroesophageal variceal bleeding. Transjugular intrahepatic portosystemic shunt can markedly reduce portal pressure and prevent recurrent variceal bleeding, but its broader use in secondary prophylaxis is limited by the risk of post-TIPS hepatic encephalopathy and liver function deterioration. The VIATORR Controlled Expansion stent is designed to allow controlled expansion between 8 and 10 mm. However, even 8-mm TIPS may still be associated with a substantial risk of overt hepatic encephalopathy. This trial evaluates an underdilated VCX-TIPS strategy, in which a commercially available 8-10 mm VIATORR Controlled Expansion stent is initially dilated only with a 6-mm balloon, aiming to achieve sufficient portal decompression while reducing the risk of excessive shunting. This is a prospective, multicenter, open-label, parallel-group, randomized superiority trial. Eligible patients with cirrhosis who have recovered from acute esophageal variceal bleeding or type 1 gastroesophageal variceal bleeding and have entered the secondary prophylaxis phase will be randomly assigned in a 1:1 ratio to receive either underdilated VCX-TIPS or endoscopic variceal ligation plus nonselective beta-blockers. The primary outcome is the composite of all-cause death or clinically significant upper gastrointestinal rebleeding within 1 year after randomization.

Participants needed: 240
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: West China HospitalUpdated: May 14, 2026Locations: 3
Eligibility criteria

Age 18 to 75 years, regardless of sex. [+6]

Hemodynamic instability, persistent active bleeding, or need for immediate rescu... [+14]

Status: Not yet recruiting

Ultrasound Prediction of Esophageal Variceal Bleeding Risk

This prospective observational study aims to evaluate the accuracy of using routine abdominal ultrasound to predict the risk of esophageal variceal bleeding in adult patients with liver cirrhosis. Esophageal variceal bleeding is a serious complication of chronic liver disease. While upper gastrointestinal endoscopy is the current standard for diagnosing and grading these varices, it is an invasive procedure. In this study, researchers will use ultrasound to measure the patient's spleen size and portal vein diameter. These non-invasive measurements will then be compared to the results of a standard upper endoscopy performed within 48 to 72 hours. The goal is to determine if these simple ultrasound measurements can reliably predict the presence, grade, and bleeding risk of esophageal varices, which could potentially reduce the need for routine invasive endoscopic screenings in the future.

Participants needed: 165
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Assiut UniversityUpdated: May 6, 2026
Eligibility criteria

Adult patients (age ≥18 years) with chronic liver disease and clinical/laborator... [+3]

Previous history of endoscopic variceal band ligation or sclerotherapy [+6]

Status: Not yet recruiting

Optimizing Endoscopic and Interventional Treatment for Portal Hypertensive Bleeding

This study aims to evaluate the impact of high-risk factors-such as elevated portal venous pressure, concurrent large extra-luminal vessels, portal vein thrombosis, and prominent portosystemic shunts-on the efficacy of endoscopic therapy. By comparing with interventional treatment, the goal is to optimize the clinical management protocol for esophageal and gastric varices, enhance the therapeutic outcomes of portal hypertension-related esophageal and gastric varices, and improve patient prognosis.

Participants needed: 1,066
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Shanghai Zhongshan HospitalUpdated: Mar 31, 2026Duration: 12 Months
Eligibility criteria

Admitted due to gastrointestinal bleeding and clinically diagnosed with portal h... [+3]

Previous history of liver transplantation [+3]

Status: Not yet recruiting

Non-invasive Predictors of Esophageal Varices and Their Correlation to Upper Endoscopic Findings

The goal of this observational study: * To evaluate the diagnostic accuracy of non-invasive markers in predicting the presence and grading of esophageal varices in children with portal hypertension. * To correlate these non-invasive markers with the severity of portal hypertension and the grade of esophageal varices to identify patients at high risk of bleeding. * To propose a defined protocol for screening esophageal varices in those children.

Participants needed: 51
Trial details
Age: Up to 18Biological sex: AllType: ObservationalSponsor: Assiut UniversityUpdated: Mar 23, 2026
Eligibility criteria

Patients aged less than 18 years diagnosed with portal hypertension either due t...

Active variceal bleeding at presentation (hemodynamic instability affects platel... [+4]

Status: Recruiting

2D-shear Wave Spleen Elastography in Clinically Significant Portal Hypertension and High-risk Varices

The primary objective of this study is to evaluate the role of spleen shear wave elastography (SWE-SSM) for ruling in and ruling out clinically significant portal hypertension (CSPH) in patients with compensated advanced chronic liver disease (cACLD) and for ruling in and ruling out high-risk esophageal varices (HRV) in patients with CSPH. Secondary objectives of the study include the investigation of the correlation between SWE-SSM and portal pressure in a subgroup of patients undergoing hepatic venous pressure gradient (HVPG) measurement and between SWE-SSM and transient elastography (TE-SSM). The values of SWE-SSM and SWE-LSM will be assessed during the ultrasound examination to which the patient will be subjected according to their care pathway. If inclusion criteria are met and informed consent is obtained, spleen elastography will be carried out (in addition to the routine SWE-LSM planned in clinical practice). Spleen elastography will not alter the standard ultrasound examination but represents a non-invasive diagnostic addition. There will be no treatment or experimental intervention that will modify the patient's condition or directly influence their clinical course. The aim is to collect data based on clinical observations without altering the treatment or the natural course of the disease.

Participants needed: 450
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSUpdated: Nov 25, 2025Locations: 1Duration: 2 Years
Eligibility criteria

Age greater than 18 years; [+1]

Presence of transjugular intrahepatic porto-systemic shunt (TIPS);· [+4]

Status: Recruiting

TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease

Porto-sinusoidal Vascular Disease (PSVD) is characterized by a portal hypertension (PH) without cirrhosis. This can induce PH complications, like digestive hemorrhage from esophageal or gastric varices, ascites, or even portal thrombosis. Due to the rarity of MVPS, the treatment of complications of portal hypertension is modeled on the methods used in cirrhotic portal hypertension with non-cardio-selective beta blockers, endoscopic ligations or diuretics in first line therapy, as proposed by the Baveno VII recommendations. In complicated or refractory forms of PH in PSVD, the place of TIPS is also discussed, as in the field of cirrhosis. However, the experience of TIPS in PSVD is limited, reported in case reports and small specifically dedicated series. No predictive factors for survival or recurrence and tolerance were well known. A larger study with control group is needed in order to better know the right time and the right indication for the use of TIPS in complicated PH PSVD-related. The study will be retrospective, multicentric involving tertiary university French centers, expert in the management of TIPS. Patients white TIPS-PSVD will be compared with historical patients with TIPS-cirrhose, matched on age, sexe, indication of TIPS. The study will not comprise new intervention, only observational in a real life condition

Participants needed: 360
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Centre Hospitalier Universitaire, AmiensUpdated: Nov 19, 2025Locations: 1
Eligibility criteria

Patient with PSVD according VALDIG criteria [+7]

no PSVD confirmed diagnosis [+8]

Status: Recruiting

Improve the Strategies of Endoscopic and Interventional Treatment of Gastroesophageal Hemorrhage in Portal Hypertension

Endoscopic esophageal variceal ligation combined with gastric variceal embolization using tissue glue is currently the first-choice method for preventing rebleeding in patients with cirrhosis and portal hypertension. However, the rebleeding rate remains relatively high. Factors such as extra-luminal vascular bundles in the esophagus and stomach walls, and portosystemic shunts significantly affect the therapeutic outcomes. Therefore, there is an urgent need to develop an individualized treatment model for esophagogastric varices based on the anatomical and hemodynamic characteristics of the varices, to stratify patient risks and provide tailored treatment options. Before the treatment of esophagogastric varices, the vascular characteristics of esophagogastric varices are assessed based on imaging data such as portal venous CT and ultrasound, as well as clinical information. Risk factors influencing bleeding from esophagogastric varices are explored, and an endoscopic and interventional variceal stratification and treatment model is constructed to provide patients with personalized options for endoscopic or interventional therapy. During the treatment of esophagogastric varices, precise endovascular embolization of the source branch vessels of esophagogastric varices is performed based on hemodynamic models. The safety and efficacy of this treatment strategy are verified through randomized controlled clinical trials. After the treatment of esophagogastric varices, the feasibility of reducing the risk of rebleeding in patients with poor endoscopic outcomes is examined by using drugs that lower portal venous pressure, such as carvedilol or novel oral anticoagulants. Factors influencing recompensation and reversal of portal hypertension are also clarified.

Participants needed: 1,450
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Shanghai Zhongshan HospitalUpdated: May 14, 2025Locations: 10
Eligibility criteria

Confirmed diagnosis of portal hypertension; [+2]

CT image slice thickness does not meet the requirements or there are artifacts; [+3]

Status: Recruiting

Fecal Calprotectin for Prediction of Esophageal Varices in Cirrhotic Patients

The goal of this cross-sectional observational study is to evaluate the accuracy of fecal calprotectin versus non-invasive scores in assessing the presence and grading of esophageal varices in Egyptian patients. Researchers will compare fecal calprotectin levels in cirrhotic patients with and without esophageal varices (EVs) and healthy subjects. researchers will also evaluate the performance of fecal calprotectin, AST to platelet ratio index (APRI) score, fibrosis-4 (FIB-4) score, albumin-bilirubin (ALBI) score, platelet-albumin-bilirubin (PALBI) score, and platelet-spleen diameter ratio (PSR) for predicting esophageal varices. Participants will undergo history-taking, clinical examination, laboratory investigations, fecal calprotectin, abdominal ultrasonography, and upper endoscopy. Endoscopic grading of esophageal varices will be done using Paquet's classification. The APRI, FIB-4, ALBI, PALBI, and PSR scores will be calculated. The performance of fecal calprotectin for predicting EVs will be compared versus other non-invasive scores.

Participants needed: 156
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Tanta UniversityUpdated: Apr 3, 2025Locations: 1
Eligibility criteria

Age ≥18 years [+1]

Patients aged < 18 years. [+7]

Status: Recruiting

Cross-section Band Ligation Versus Stepladder Band Ligation of Esophageal Varices

The goal of this randomized controlled trial is to evaluate the cross-section band ligation technique versus the stepladder band ligation technique in esophageal varices prophylaxis. Researchers will compare cross-section and step ladder band ligation techniques for esophageal varices prophylaxis regarding efficacy, side effects, variceal recurrence, and survival. Participants will undergo history-taking, clinical examination, laboratory investigations, and upper endoscopy. Index upper endoscopy will be performed to evaluate the presence, size, and grade of esophageal varices. Patients will be randomly assigned to endoscopic band ligation (EBL) either by cross-section or stepladder techniques every two to four weeks until eradication. After eradication of varices, endoscopy will be repeated after 3-6 months to check for variceal recurrence. For a period of 6 months, all patients in the treatment groups will be followed up every 3 months with clinic visits, including laboratory testing, evaluation of treatment-related side effects, bleeding rates, and mortality from EBL treatment.

Participants needed: 320
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Tanta UniversityUpdated: Mar 18, 2025Locations: 1
Eligibility criteria

Aged >18 years. [+2]

History of variceal bleeding or previous primary prevention of varices. [+9]

Status: Recruiting

Endoscopic Variceal Ligation vs Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With HCC

The goal of this clinical trial is to evaluate whether endoscopic variceal ligation (EVL) or carvedilol is more effective at preventing the first esophageal variceal bleeding (EVB) in patients with hepatocellular carcinoma (HCC). It will also learn about the safety of EVL and carvedilol in patients with HCC. The main questions it aims to answer are: Whether EVL or carvedilol is more effective at preventing initial EVB in patients with HCC with high-risk EVs. What medical problems do participants have when undergoing EVL or taking carvedilol? Researchers will compare the efficacy and safety of EVL to carvedilol for the prevention of first EVB in patients with HCC. Participants will: Undergo EVL every 3-4 weeks until variceal eradication and then receive regular endoscopic follow-up according to the protocol, or Take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable). Visit the clinic once every 2-3 months for checkups and tests. Keep a diary of their vital signs (SBP, DBP, and HR) as well as symptoms.

Participants needed: 120
Trial details
Phase: Phase 4Age: 20-90Biological sex: AllType: InterventionalSponsor: Taipei Veterans General Hospital, TaiwanUpdated: Feb 13, 2025Locations: 1
Eligibility criteria

Age less than 20 years or greater than 90 years. [+6]

Status: Recruiting

Carvedilol Plus EVL or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders

The goal of this clinical trial is to evaluate whether carvedilol plus endoscopic variceal ligation (EVL) is more effective for the primary prevention of esophageal variceal bleeding than carvedilol alone in carvedilol non-responders. It will also learn about the safety of carvedilol combined with EVL in patients with cirrhosis. The main questions it aims to answer are: Whether carvedilol plus EVL is more effective than carvedilol alone in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol. What medical problems do participants have when taking carvedilol or taking carvedilol combined with undergoing EVL? Researchers will compare the efficacy and safety of carvedilol with or without EVL in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol. Participants will: Take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol, or Take carvedilol alone every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable). Visit the clinic once every 2-3 months for checkups and tests. Keep a diary of their vital signs (SBP, DBP, and HR) as well as symptoms.

Participants needed: 80
Trial details
Phase: Phase 4Age: 18-90Biological sex: AllType: InterventionalSponsor: Taipei Veterans General Hospital, TaiwanUpdated: Feb 11, 2025Locations: 1
Eligibility criteria

Age under 18 or over 90 years. [+6]

Status: Recruiting

Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding

Carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Participants needed: 306
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Sherief Abd-ElsalamUpdated: Aug 5, 2020Locations: 1
Eligibility criteria

• Aged >18 years [+2]

• History of variceal bleeding or previous primary prevention of varices. [+9]