Using a detachable clip and tissue glue to treat bleeding gastric varices
Detachable Clip-assisted Endoscopic Cyanoacrylate Injection in the Treatment of Gastric Varices Under X-ray Perspective
This study is testing a new way to stop bleeding from swollen veins in the stomach using a special clip and glue for people with liver cirrhosis who are at high risk for this problem.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanjing University of Traditional Chinese Medicine Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06670157 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a modified sandwich injection technique using tissue glue, assisted by a detachable clip, for treating gastric varices bleeding. It is a single-arm exploratory study that focuses on patients diagnosed with liver cirrhosis and at high risk for gastric variceal bleeding. Participants will undergo endoscopic procedures to assess the effectiveness of this innovative approach in managing their condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with diagnosed gastric varices and a history of variceal bleeding.
Not a fit: Patients under 18 years old, those with regional portal hypertension, or those with severe concurrent health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of bleeding from gastric varices in patients with liver cirrhosis.
How similar studies have performed: While this approach is innovative, similar studies using endoscopic techniques for managing variceal bleeding have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The subject voluntarily signs the informed consent for this experiment; According to clinical manifestation, laboratory examination, imaging examination, or liver biopsy in the diagnosis of liver cirrhosis patients; The endoscopy diagnosed gastric varices (gastroesophageal varices, gastroesophageal varices type 2 or type 1 isolated gastric varices type 1); High risk of gastric varices or has a history of gastric varices bleeding. The initial fluid resuscitation patients before or after the recovery hemodynamic stability; The age of 18 years old or more. Exclusion Criteria: * \< 18 years old; Regional portal hypertension; Always have a liver transplant, via the jugular intrahepatic portal vein system bypass or splenectomy combined varices cut-out art history; A concurrent hepatorenal syndrome and/or multiple organ failure; Significant impact on survival of malignant tumor; Pregnancy or lactation; A known allergy to iodine.
Where this trial is running
Nanjing, Jiangsu
- Eastern Theater General Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: ji xuan, doctor — Eastern Theater General Hospital
- Study coordinator: ji xuan, doctor
- Email: changgyuu@163.com
- Phone: 13140718720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.