Comparing urgent and non-urgent endoscopy for treating variceal bleeding
Timing of Endoscopic Intervention in Patients With Cirrhosis With Acute Variceal Upper Gastrointestinal Hemorrhage (TEACH Trial): a Randomized Clinical Trial
This study is testing if getting urgent endoscopy treatment within 6 hours is better than waiting 6 to 24 hours for people with severe bleeding from varices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jinling Hospital, China Academic / other |
| Locations | 4 sites (Nanjing, Jiangsu and 3 other locations) |
| Trial ID | NCT04786743 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine whether urgent endoscopic intervention within 6 hours of gastroenterological consultation is more effective than non-urgent intervention between 6 to 24 hours in reducing rebleeding rates in patients with acute variceal hemorrhage. It is a multi-centered, prospective, randomized, and controlled trial involving 400 patients who will be randomly assigned to one of the two intervention groups. The primary endpoint is the incidence of rebleeding within 42 days after initial treatment. The study follows strict ethical guidelines and has received necessary approvals from relevant ethics committees.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with cirrhosis who exhibit clinical symptoms of acute variceal hemorrhage and are hemodynamically stable.
Not a fit: Patients who are pregnant, lactating, under 18 years old, or have taken anticoagulant or antiplatelet drugs within the last two weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients experiencing acute variceal hemorrhage, potentially reducing the risk of rebleeding.
How similar studies have performed: Other studies have explored endoscopic interventions for variceal bleeding, but this specific comparison of urgent versus non-urgent timing is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (I) patients who have pathological or clinical and imaging evidence indicating a diagnosis of cirrhosis; (II) patients with clinical symptoms associated with AVH (hematemesis, melena or hematochezia) before admission or during hospitalization; (III) patients who are hemodynamically stable before or after initial fluid resuscitation. Exclusion Criteria: (I) pregnancy; (II) lactation; (III) less than 18 years; (IV) patients with a history of taking anticoagulant or antiplatelet drugs within 2 weeks prior to admission.
Where this trial is running
Nanjing, Jiangsu and 3 other locations
- Affiliated Jinling Hospital, Medical School of Nanjing University — Nanjing, Jiangsu, China (Recruiting)
- Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
- First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
- The Affiliated Wuxi People's Hospital of Nanjing Medical University — Wuxi, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Fangyu Wang, M.D. — Jinling Hospital, China
- Study coordinator: Zhuoxin Yang, M.D.
- Email: yzxbeyond@163.com
- Phone: +8618761679906
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.