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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard upper endoscopy | Active Comparator | standard upper endoscopy |
|
| CAP | Experimental | upper endoscopy with the placement of an endoscopic cap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| upper endoscopy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| procedure time until endoscopic hemostasis is achieved | procedure time until endoscopic hemostasis is achieved | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| therapeutic success rate | therapeutic success rate | 1 month |
| clinical success rate | clinical success rate | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clara YZET, MD | Contact | 33+3 22 08 88 50 | yzet.clara@chu-amiens.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire d'Amiens | Recruiting | Amiens | Picardie | 80000 | France |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D005773 | Gastroscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| CAP | Procedure | 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 |
|
| time until bleeding localization | time until bleeding localization | up to 1 month |
| duration of hemostasis achievement | duration of hemostasis achievement | up to 1 month |
| endoscope stability | assessment of endoscopist satisfaction in terms of endoscope stability | up to 1 month |
| lesion visualization | lesion visualization | up to 1 month |
| hemostasis | hemostasis | up to 1 month |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |