Cap-assisted Endoscopy, Upper Gastro Intestinal Bleeding, Endoscopy
Conditions
Keywords
Cap-assisted endoscopy, upper gastro intestinal bleeding, endoscopy
Brief 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.
Interventions
PROCEDUREupper 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
PROCEDURECAP
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
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| procedure time until endoscopic hemostasis is achieved | 1 month | procedure time until endoscopic hemostasis is achieved |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| therapeutic success rate | 1 month | therapeutic success rate |
| clinical success rate | 1 month | clinical success rate |
| time until bleeding localization | up to 1 month | time until bleeding localization |
| duration of hemostasis achievement | up to 1 month | duration of hemostasis achievement |
| endoscope stability | up to 1 month | assessment of endoscopist satisfaction in terms of endoscope stability |
| lesion visualization | up to 1 month | lesion visualization |
| hemostasis | up to 1 month | hemostasis |
Countries
France
Contacts
Primary ContactClara YZET, MD
Outcome results
None listed