About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patient > 18 years old
Upper GI bleeding suspected in presence of melena or hematemesis
Glasgow Blatchford score > 8
Upper gastroscopy at Amiens University Hospital
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
upper endoscopy
Procedure/SurgeryAll 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
Procedure/SurgeryAll 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
Treatment groups
Trial outcomes
Primary outcomes
procedure time until endoscopic hemostasis is achieved
procedure time until endoscopic hemostasis is achieved
Secondary outcomes
therapeutic success rate
therapeutic success rate
clinical success rate
clinical success rate
time until bleeding localization
time until bleeding localization
duration of hemostasis achievement
duration of hemostasis achievement
Sponsors and contacts
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