Upper Gastrointestinal Disorder
Conditions
Keywords
Gastroscopy, Upper endoscopy, Gastroscope, Single-use, Reusable
Brief summary
The aim of this clinical trial is to investigate whether single-use gastroscopes perform comparably to reusable gastroscopes when used in an endoscopy unit during a period of reduced endoscope reprocessing capacity. The main question the study aims to answer is: \- How do endoscopists evaluate the performance of single-use gastroscopes compared with reusable gastroscopes in elective and subacute patients undergoing gastroscopy in the endoscopy unit? Researchers will compare single-use and reusable gastroscopes to determine whether they provide comparable clinical performance. In addition, the study will evaluate the economic consequences of temporarily implementing single-use gastroscopes during a period of reduced reprocessing capacity, as well as compare selected clinical outcomes, including technical success, procedural complications, and the frequency of endoscopic findings. Participants undergoing gastroscopy during the first study period will be examined using a single-use gastroscope. Participants undergoing gastroscopy during the second study period will be examined using a reusable gastroscope.
Interventions
DEVICEAmbu aScope Gastro
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
DEVICEReusable diagnostic gastroscopes (Olympus)
Reusable diagnostic gastroscopes from Olympus are used in the reusable group.
Sponsors
Zealand University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Non-inferiority quality assurance study comparing a period during which single-use gastroscopes are used with a period during which reusable gastroscopes are used.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective or subacute gastroscopy in the endoscopy unit * Age ≥ 18 years
Exclusion criteria
* Surveillance gastroscopy for Barrett's esophagus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopist-rated composite usability score | Procedure day (immediately after completion of the procedure) | Comparison of the composite endoscopist-rated performance score of single-use and reusable gastroscopes. The composite score will be calculated as the mean of all items rated on a 5-point Likert-scale questionnaire. |
| Cost per gastroscopy during the single-use period compared with the reusable period | During the gastroscopy procedure and completion of all procedure-related activities (same day). | Cost per gastroscopy (EUR) will be calculated for each study period using hospital administrative and procedural data. The calculation will include: * Diagnosis-Related Group (DRG) reimbursement value for gastroscopy * Purchase cost of the single-use gastroscope * Reprocessing cost of reusable gastroscopes * Staff time required for preparation and post-procedure work for each gastroscope type * Additional hospital costs associated with transferring patients to other hospitals or private providers due to reduced endoscope reprocessing capacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of single-use gastroscopes vs reusable gastroscopes | During the procedure | Technical success will be determined by retrospective review of the endoscopy report and medical record using predefined study criteria. Technical success is defined as successful advancement of the gastroscope to the second part of the duodenum and the ability to identify or exclude the suspected diagnosis. In procedures with an impassable stenosis or tumor, technical success is defined as successful identification of the lesion and obtaining biopsies sufficient for diagnostic evaluation when clinically indicated. The outcome will be reported as the proportion of procedures meeting the predefined criteria for technical success. |
| Cross-over rate | During the procedure | Frequency of gastroscopies requiring cross-over to another gastroscope |
| Frequency of predefined endoscopic findings | During the procedure | Endoscopic findings will be determined by retrospective review of the endoscopy report using predefined study categories. The frequency of each predefined endoscopic finding will be compared between the single-use and reusable gastroscope groups. |
| Complications | 24 hours and 72 hours follow-up after the procedure | Complications related to gastroscopy |
| 30-day mortality | 30 days after the procedure | Mortality within 30 days after the procedure |
| Duration of procedure | During the procedure | The time from intubation with the gastroscope until removal of the gastroscope from the esophagus |
| Technical success rate of therapeutic endoscopic procedures | During the procedure | Technical success of therapeutic endoscopic procedures will be determined by retrospective review of the endoscopy report and medical record using predefined study criteria. Therapeutic procedures include, but are not limited to, endoscopic hemostasis of bleeding ulcers, variceal band ligation, stent placement, foreign body removal, and dilation. Success is defined as successful completion of the intended therapeutic intervention according to the predefined criteria for each procedure (e.g., successful hemostasis, successful band ligation, successful stent deployment, or successful removal of foreign bodies). The outcome will be reported as the proportion of therapeutic procedures meeting the predefined criteria for technical success and compared between the single-use and reusable gastroscope groups. |
| Diagnostic adequacy rate of endoscopic biopsies | After completion of the pathology examination (up to 2 months after the procedure) | Diagnostic adequacy of endoscopic biopsies will be determined by retrospective review of the pathology report and endoscopy report using predefined study criteria. A biopsy will be considered adequate if the pathological examination provides sufficient information to either establish or exclude the suspected diagnosis. The outcome will be reported as the proportion of biopsies considered diagnostically adequate among procedures where biopsies were obtained and compared between the single-use and reusable gastroscope groups. |
Countries
Denmark
Contacts
CONTACTCamilla Kjelkvist-Born, MD
CONTACTMarie Louise Malmstrøm, MD, PhD
STUDY_CHAIRLasse Bremholm Hansen, PhD,ass.prof
Surgical department of Zealand University Hospital
Outcome results
None listed