Single-use Versus Reusable Gastroscopes in Patients With Upper Gastrointestinal Bleeding.
- Conditions
- Upper Gastrointestinal Bleeding
- Interventions
- Device: Endoscopic hemostasis using a Esophagogastroduodenoscopy
- Registration Number
- NCT06192355
- Lead Sponsor
- University Hospital Augsburg
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Glasgow-Blatchford score (GBS) >2
- Clinical signs of upper bleeding
- pregnancy
- Unable to provide consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single-use gastroscope Endoscopic hemostasis using a Esophagogastroduodenoscopy A disposable endoscope designed for a one-time use during a Gastroscopy, eliminating the need for reprocessing or sterilization. After a single procedure, the entire gastroscope is discarded, reducing the risk of cross-contamination and ensuring a fresh, sterile instrument for each patient intervention reusable gastroscope Endoscopic hemostasis using a Esophagogastroduodenoscopy A durable endoscope designed for multiple uses after thorough reprocessing and sterilization
- Primary Outcome Measures
Name Time Method intraprocedural technical success Up to 20 minutes defined as reaching the descending duodenum and adequately assessing for the presence of a bleeding site
- Secondary Outcome Measures
Name Time Method Length of intervention Up to 60 minutes measured from initiation to achievement of hemostasis
blood transfusions Up to 30 days Need for blood transfusion due to a hemorrhage-related decrease in hemoglobin levels ≤ 70 g/L
re-bleeding rate Up to 30 days need for further endoscopic, interventional-angiographic, or surgical intervention within 30 days due to upper GI-bleeding
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
Adverse events Up to 30 days Occurrence of adverse events, such as perforation, bleeding exacerbation, aspiration, and infection.
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
Trial Locations
- Locations (1)
University Hospital of Augsburg
🇩🇪Augsburg, Bavaria, Germany