NCT06970509 Improve the Strategies of Endoscopic and Interventional Treatment of Gastroesophageal Hemorrhage in Portal Hypertension
| NCT ID | NCT06970509 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Esophageal Varices |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,450 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,450 participants in total. It began in 2025-03-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Shiyao Chen, Ph.D.
PRINCIPAL INVESTIGATOR
Shanghai Zhongshan Hospital
Frequently Asked Questions
Who can join the NCT06970509 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Varices. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06970509 currently recruiting?
Yes, NCT06970509 is actively recruiting participants. Contact the research team at wang.yiting@zs-hospital.sh.cn for enrollment information.
Where is the NCT06970509 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Nanchang, China, Shenyang, China and 6 additional locations.
Who is sponsoring the NCT06970509 clinical trial?
NCT06970509 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is Shiyao Chen, Ph.D. at Shanghai Zhongshan Hospital. The trial plans to enroll 1,450 participants.