Upper Gastrointestinal Bleeding
Conditions
Keywords
Endoscopy, Emergency
Brief summary
Controlled-randomized trial evaluating single-use versus reusable gastroscopes in patients with upper gastrointestinal bleeding.
Detailed description
Acute upper gastrointestinal bleeding is a common medical emergency. According to guidelines, endoscopic evaluation should be performed within 24 hours. With an overall high incidence and an overall high number of diagnostic and therapeutic endoscopic procedures, the introduction of new endoscopic concepts may have a profound impact on outcomes as well as cost-effectiveness in upper gastrointestinal bleeding. For this purpose, the use of single-use gastroscopes represents an interesting possibility. Hygiene issues in the emergency situation are also relevant. The previous feasibility study One-Scope I demonstrated that the diagnosis as well as the therapy of upper gastrointestinal bleeding is possible with single-use gastroscopes. In this follow-up study, the investigators compare the use of single-use versus reusable gastroscopes in participants with suspected upper gastrointestinal bleeding in a randomized controlled trial.
Interventions
DEVICEEndoscopic hemostasis using a Esophagogastroduodenoscopy
performing an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites
Sponsors
University Hospital Augsburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Glasgow-Blatchford score (GBS) \>2 * Clinical signs of upper bleeding
Exclusion criteria
* pregnancy * Unable to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraprocedural technical success | Up to 20 minutes | defined as reaching the descending duodenum and adequately assessing for the presence of a bleeding site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| re-bleeding rate | Up to 30 days | need for further endoscopic, interventional-angiographic, or surgical intervention within 30 days due to upper GI-bleeding |
| blood transfusions | Up to 30 days | Need for blood transfusion due to a hemorrhage-related decrease in hemoglobin levels ≤ 70 g/L |
| Length of Stay | Up to 30 days | Duration of inpatient stay, measured from the day of admission to the day of discharge |
| intraprocedural clinical success | Up to 45 Minutes | defined as successful endoscopic hemostasis during the examination if required |
| cross over to reusable gastroscope | Up to 60 Minutes | Switch to a reusable gastroscope in case of non-achieved technical or clinical success, such as unsuccessful hemostasis, insufficient assessment of the bleeding source, or inability to reach the descending duodenum |
| Adverse events | Up to 30 days | Occurrence of adverse events, such as perforation, bleeding exacerbation, aspiration, and infection. |
| Length of intervention | Up to 60 minutes | measured from initiation to achievement of hemostasis |
Countries
Germany
Contacts
Primary ContactChristoph Römmele, MD
Backup ContactAlanna Ebigbo, MD
Outcome results
None listed