Comparing OTSC and Angiographic Embolization for Severe Upper Gastrointestinal Bleeding
Official title: Endoscopic Application of Over-the-scope Clips (OTSC) vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding: a Multicenter Randomized Comparison
Run by Chinese University of Hong Kong · NCT04902248 · Data updated 2026-11-12
This study is testing whether a new clip treatment can work as well as a traditional procedure for stopping severe bleeding in the stomach and intestines for patients with certain types of bleeding.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 236 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 5 sites (Beijing, Beijing Municipality and 4 other locations) |
| Status | Recruiting |
| Started | November 27, 2021 |
| Main results expected | September 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT04902248 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults presenting with acute upper gastrointestinal bleeding and documented bleeding lesions who have experienced persistent or recurrent bleeding after initial endoscopic treatment.
✕Probably not a fit
Patients under 18 years, pregnant or lactating women, and those with known allergies to intravenous contrast will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effectiveness of the Over-the-Scope Clip (OTSC) system against angiographic embolization in patients experiencing refractory non-variceal upper gastrointestinal bleeding. The study hypothesizes that the endoscopic application of OTSC may yield outcomes similar to those of angiographic embolization, potentially allowing for a less invasive first-line treatment option. Patients with acute bleeding from peptic ulcers or other non-variceal causes will be included, and the trial will assess the rates of further bleeding and mortality associated with each treatment method. The goal is to establish a clearer management algorithm for these patients.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients with severe upper gastrointestinal bleeding, potentially reducing mortality rates.
How similar studies have gone: While there have been retrospective studies comparing these treatment modalities, this trial represents a novel approach as it aims to provide direct comparative evidence between OTSC and angiographic embolization.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Patients presented with overt signs of acute upper gastrointestinal bleeding (hematemesis, melena and/or hypotension) 2. documented bleeding lesion at endoscopy (ulcer, dieulafoy's lesion and others), further bleeds (persistent or recurrent) after endoscopic hemostasis (thermal or hemoclips) as defined by an International Consensus Group Exclusion Criteria: 1. without a full informed consent from the patient or his next of kin 2. Age \<18 years 3. Pregnant 4. Lactating women 5. patients with known allergy to intravenous contrast
Where it's running
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Beijing friendship Hospital
Beijing, Beijing Municipality, China Recruiting -
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China Recruiting -
Huaxi Hospital of Sichuan University
Chengdu, Sichuan, China Recruiting -
Endoscopy Centre, Prince of Wales Hospital
Hong Kong, N.t., Hong Kong Recruiting -
King Chulalongkorn Memorial Hospital
Bangkok, Bangkok, Thailand Recruiting
Study contacts
- Principal investigator: Yau Wong James Lau, MD — The Chinese University of HongKong
- Study coordinator: Yau Wong James Lau, MD
- Email: laujyw@surgery.cuhk.edu.hk
- Phone: 35052640
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.