K22.2
Conditions
Interventions
Group 1: Participant recruitment is anticipated to take place between July 2026 and July 2027. Patients with esophageal strictures and an independently established clinical indication for endoscopic d
Sponsors
Klinikum Oldenburg, Universitätsklinik für Innere Medizin – Gastroenterologie, Hepatologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Independent clinical indication for diagnostic and/or interventional gastrointestinal endoscopy for esophageal stricture 2. Patients capable of giving consent and aged > 18 years 3. Sufficient proficiency in the German language, both verbally and in writing 4. Written informed consent for study participation available
Exclusion criteria
Exclusion criteria: 1. Contraindication to the planned endoscopic procedure 2. ASA-classification > 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is interobserver variability in the endoscopic assessment of esophageal stricture diameter. This parameter is assessed by having multiple raters independently review endoscopic video sequences once and report the estimated stricture diameter. Data collection is performed using a study-specific assessment form. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Quality metrics of the endoscopic procedures according to the quality indicators of the European Society of Gastrointestinal Endoscopy (ESGE), personnel time required for standard documentation, and interobserver variability in stricture quantification by expert endoscopists. These endpoints are assessed after recording of the video sequences using endoscopic documentation and independent assessment of the video sequences by endoscopists. | — |
Countries
Germany
Contacts
Public ContactMark Ellrichmann
Klinikum Oldenburg, Universitätsklinik für Innere Medizin – Gastroenterologie, Hepatologie
Outcome results
None listed