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Recruiting Not applicable

Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?

NCT07268365 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-10-16
Last updated
2025-12-05

Condition(s) studied

Cap-assisted EndoscopyUpper Gastro Intestinal BleedingEndoscopy

Investigational drug(s) / intervention(s)

upper endoscopyCAP

upper endoscopy: All patients with the inclusion criteria will be randomized (randomization 1:1) to undergo either an upper endoscopy with an endoscopic cap or without a cap

CAP: All patients with the inclusion criteria will be randomized (randomization 1:1) to undergo either an upper endoscopy with an endoscopic cap or without a cap

Study summary

High digestive bleeding (HDH) is a medical emergency associated with high morbidity and mortality rates and significant healthcare costs. Upper endoscopy can locate the bleeding and treat it. However, the source of bleeding can be difficult to identify, even for the most experienced endoscopists, due to the location of the bleeding (posterior wall of the bulb, gastric or duodenal folds, papillary region, esophagogastric junction), instability of the tube due to gastric and pyloric contractions and respiratory movements, leading to longer procedure times, hemostasis failure, or even the absence of bleeding visualization. The use of a cap attached to the endoscope facilitates exploration of blind areas of the colonic mucosa located behind folds, thus reducing the rate of missed polyps and cecal intubation time. To date, there is no study evaluating the systematic use of a cap in patients with suspected high digestive bleeding. A series of four cases demonstrated its benefit, allowing for better exposure of the bleeding lesion, better unfolding of intestinal folds, and thus a more effective and quicker hemostatic treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • procedure time until endoscopic hemostasis is achieved — 1 month
    procedure time until endoscopic hemostasis is achieved

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier Universitaire d'Amiens Amiens Picardie Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07268365 on ClinicalTrials.gov ↗ ← All trials in France