Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ? (CAP)

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Upper Gastro Intestinal Bleeding; Cap-assisted Endoscopy; Endoscopy

Treatments: Procedure: CAP; Procedure: upper endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT07268365

PI2025_843_0158

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

standard upper endoscopy

Active Comparator group

Description:

standard upper endoscopy

Treatment:

Procedure: upper endoscopy

CAP

Experimental group

Description:

upper endoscopy with the placement of an endoscopic cap

Treatment:

Procedure: upper endoscopy

Procedure: CAP