Using a cap on the endoscope to find and treat upper GI bleeding
Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?
This trial tests whether adding a small clear cap to the tip of the endoscope helps doctors find and stop bleeding in adults with suspected acute upper gastrointestinal bleeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens, Picardie) |
| Trial ID | NCT07268365 on ClinicalTrials.gov |
What this trial studies
Adults presenting with melena or hematemesis and a high Glasgow-Blatchford score at Amiens University Hospital will undergo upper endoscopy using a cap attached to the scope to improve visualization of hidden mucosal areas. The cap is intended to expose blind spots behind folds and stabilize the scope to facilitate endoscopic hemostasis of gastric or duodenal ulcers (Forrest Ia–IIb). Outcomes will include identification rate of the bleeding source, hemostasis success, procedure time, and need for repeat interventions, with follow-up at the same center. This approach builds on cap-assisted techniques used in colonoscopy and limited case reports in upper GI bleeding but has not been tested systematically in larger cohorts.
Who should consider this trial
Good fit: Adults over 18 with suspected upper GI bleeding (melena or hematemesis), a Glasgow-Blatchford score >8, presenting to and able to follow up at Amiens University Hospital, and with a gastric or duodenal ulcer requiring endoscopic hemostasis (Forrest Ia–IIb).
Not a fit: Patients with portal hypertension, known liver failure, variceal bleeding, lesions beyond the second portion of the duodenum, bleeding from esophagitis, or angiodysplasias are excluded and unlikely to benefit from this cap-assisted approach.
Why it matters
Potential benefit: If successful, cap-assisted endoscopy could lead to faster identification and control of bleeding, fewer repeat procedures, and lower complication rates and costs.
How similar studies have performed: Cap-assisted endoscopy has improved detection in colonoscopy and a small four-case series suggested benefit in upper GI bleeding, but no larger trials have assessed systematic use in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient \> 18 years old * Upper GI bleeding suspected in presence of melena or hematemesis * Glasgow Blatchford score \> 8 * Upper gastroscopy at Amiens University Hospital * Follow-up at Amiens university hospital * Presence of gastric or duodenal ulcer requiring endoscopic hemostasis (FORREST Ia, Ib, IIa, IIb) * No opposition to the study * No guardianship or curators Exclusion Criteria: * Patient with clinical suspicion of portal hypertension * Known liver failure * Patient with digestive hemorrhage related to a lesion located beyond the 2nd duodenum * Patient with digestive hemorrhage related to a varicose lesion (esophageal or gastric varices) * Patient with bleeding associated with esophagitis * Patient with bleeding associated with angiodysplasias
Where this trial is running
Amiens, Picardie
- Centre Hospitalier Universitaire d'Amiens — Amiens, Picardie, France (Recruiting)
Study contacts
- Study coordinator: Clara YZET, MD
- Email: yzet.clara@chu-amiens.fr
- Phone: 33+3 22 08 88 50
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.