NCT07268365

Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cap-assisted Endoscopy
• Upper Gastro Intestinal Bleeding
• Endoscopy

Interventions

Type	Name	Description
PROCEDURE	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
PROCEDURE	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

Timeline

• Start date: 2025-10-16
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: France