Improving treatment strategies for bleeding from esophageal varices in portal hypertension

Improve the Strategies of Endoscopic and Interventional Treatment of Gastroesophageal Hemorrhage in Portal Hypertension: Novel Strategies for Diagnosis, Treatment and Prognostic Assessment System of Cirrhotic Portal Hypertension

This study is trying to find better ways to treat bleeding from swollen veins in the esophagus for people with portal hypertension by personalizing treatment based on their specific conditions.

Quick facts

• Study type: Observational
• Enrollment: 1450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 10 sites (Guangzhou, Guangdong and 9 other locations)
• Trial ID: NCT06970509 on ClinicalTrials.gov

What this trial studies

This study focuses on enhancing the treatment of esophageal varices in patients with portal hypertension by developing an individualized treatment model. It assesses the vascular characteristics of esophagogastric varices using imaging techniques like portal venous CT and ultrasound, alongside clinical data. The goal is to stratify patient risks and provide tailored treatment options to reduce the high rebleeding rates associated with current methods. By understanding the anatomical and hemodynamic factors affecting treatment outcomes, the study aims to improve patient care.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with portal hypertension who have esophageal and/or gastric varices confirmed by endoscopy.

Not a fit: Patients without esophageal and/or gastric varices or those with severe life-threatening conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the rebleeding rates in patients with portal hypertension and esophageal varices.

How similar studies have performed: While there have been studies on endoscopic treatments for varices, this individualized approach based on anatomical and hemodynamic characteristics is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Confirmed diagnosis of portal hypertension;
2. Underwent imaging and endoscopic examination or treatment within one week after admission;
3. Endoscopy revealed the presence of esophageal and/or gastric varices.

Exclusion Criteria:

1. CT image slice thickness does not meet the requirements or there are artifacts;
2. Endoscopy shows no presence of esophageal and/or gastric varices;
3. Presence of severe life-threatening diseases of the circulatory, hematological, or respiratory systems;
4. Lack of important historical medical information or other relevant data.

Where this trial is running

Guangzhou, Guangdong and 9 other locations

• Southern Medical University Nanfang Hospital — Guangzhou, Guangdong, China (Recruiting)
• The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• People's Liberation Army Northern Theater General Hospital — Shenyang, Liaoning, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Shandong Provincial Hospital — Jinan, Shandong, China (Recruiting)
• Renji Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Shiyao Chen, Ph.D. — Shanghai Zhongshan Hospital
• Study coordinator: Yiting Wang, Ph.D.

Conditions Esophageal Varices; Portal Hypertension; Endoscopic Treatment