No registrations found.
ID
Source
Brief title
Health condition
gastric premalignant lesions, intestinal metaplasia
voorstadia maagkanker, intestinale metaplasie
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The diagnostic accuracy for the endoscopic diagnosis of intestinal metaplasia in Sydney biopsy locations
Secondary outcome
1. Reproducibility of endoscopic staging after expert review
2. Reproducibility of histopathology for detection of intestinal metaplasia
3. Number of dysplastic or neoplastic lesions detected
4. Longer inspection time of gastric mucosa increases accuracy
Background summary
Rationale
Although there has been a decline in the incidence of gastric adenocarcinoma, particularly in the Western world, it remains a major cause of cancer mortality. The key to having a significant impact on not only the prognosis of gastric cancer but also its global economic burden is to accurately identify the individuals at risk and intervene prior to them establishing gastric cancer through surveillance and existing efficacious therapies, including endoscopic resection. By embracing the significant improvements in endoscopic technology and changing the staging paradigm to an endoscopy led approach we will empower the endoscopist to risk stratify individuals with greater accuracy and decrease the already huge burden placed on our endoscopy and histopathology departments.
Objective
To evaluate the accuracy and reproducibility of enhanced endoscopic imaging for staging chronic atrophic gastritis.
Study design
Prospective evaluation of a diagnostic test
Study population
Patient already in surveillance for premalignant stomach lesions, or patients with new found lesions will be asked to participate in the current trial.
Intervention
Patients will be evaluated on separate occasions using standard white-light endoscopy plus random biopsies (current diagnostic strategy) and the using enhanced endoscopic imaging with targeted biopsies (proposed diagnostic strategy). We will compare both approaches using histopathology. Subsequently, a blood test will be drawn.
Study objective
Enhanced endoscopic imaging, including high-definition white light endoscopy and virtual chromoendoscopy, alongside targeted biopsies provides an accurate and reproducible assessment of chronic atrophic gastritis disease extent and staging, when compared to the current practice of white light endoscopy and random biopsies through the Sydney protocol biopsy strategy.
Study design
White light endoscopy with biopsies + serology samples at baseline
After 6 months narrow band imaging endoscopy with biopsies
Intervention
: Patients will be evaluated on separate occasions using standard white-light endoscopy plus random biopsies (current diagnostic strategy) and the using enhanced endoscopic imaging with targeted biopsies (proposed diagnostic strategy). We will compare both approaches using histopathology. Subsequently, a blood test will be drawn.
Inclusion criteria
1. All patients referred to the endoscopy department for an upper gastrointestinal endoscopy for investigation of symptoms, screening or surveillance, who are found to have chronic atrophic gastritis between November 2018 and May 2020.
2. Patients will be over the age of 18 years old.
3. Patients must be able to give informed consent.
Exclusion criteria
1. Patients with gastric neoplasia not amenable to endoscopic resection
2. Patient who do not have an indication for Sydney biopsy staging on standard WLE
3. Patients with significant comorbidities
4. Patients with coagulation disorders
5. Patients with previous gastric surgery
6. Being unable to complete the biopsy protocol on either endoscopy session
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6389 |
| NTR-old | NTR7661 |
| Other | : MEC-2018-078 |