Clinical trial · Interventional
Novel Approach to Surveillance of Gastric Lesions
A Novel Approach to the Surveillance of Pre-Malignant Gastric Lesions
NCT04251403CI-TRIAL-00043106unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This will be a pilot study investigating the feasibility of using pressurized irrigation of the stomach mucosa to obtain gastric aspirate cell samples for analysis and identification of premalignant lesions of the stomach.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrophic Gastritis | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Dysplasia | — | UNRESOLVED | — |
| Intestinal Metaplasia of Gastric Mucosa | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mucosal Irrigation | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mucosal Irrigation
- description
- Following routine endoscopic evaluation, investigators will utilize the ERBEJET 2 device (ERBE USA Inc), which is commercially available for the treatment of mucosal lesions, to sample cells from the mucosal surface of the stomach. The aspirate will be collected for cytologic/pathologic assessment.
- interventionNames
- Diagnostic Test: Mucosal Irrigation
Primary outcomes (1)
- measure
- Correlation of pathologic diagnosis from gastric aspirate compared with diagnosis from standard endoscopic inspection and biopsies.
- timeFrame
- Intra-procedural
- description
- Investigators will compare how the diagnosis determined from pathologic/cytologic analysis gastric aspirate samples will compare with diagnosis obtained from standard endoscopic inspection and biopsies. The diagnoses of interest will be normal mucosa, atrophic gastritis, intestinal metaplasia, dysplasia, or malignancy. This will be reported as the percentage of concordant diagnoses.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals with a known history of gastric precursor lesions (atrophic gastritis, intestinal metaplasia, history of dysplasia) who are presenting for routine surveillance endoscopy Exclusion Criteria: * Personal history of gastric cancer * Personal history of irritable bowel disease
References
Publications (4)
- BACKGROUNDHamashima C. Current issues and future perspectives of gastric cancer screening. World J Gastroenterol. 2014 Oct 14;20(38):13767-74. doi: 10.3748/wjg.v20.i38.13767. PMID 25320514
- BACKGROUNDGupta S, Li D, El Serag HB, Davitkov P, Altayar O, Sultan S, Falck-Ytter Y, Mustafa RA. AGA Clinical Practice Guidelines on Management of Gastric Intestinal Metaplasia. Gastroenterology. 2020 Feb;158(3):693-702. doi: 10.1053/j.gastro.2019.12.003. Epub 2019 Dec 6. No abstract available. PMID 31816298
- BACKGROUNDKim GH, Liang PS, Bang SJ, Hwang JH. Screening and surveillance for gastric cancer in the United States: Is it needed? Gastrointest Endosc. 2016 Jul;84(1):18-28. doi: 10.1016/j.gie.2016.02.028. Epub 2016 Mar 3. PMID 26940296
- BACKGROUNDBASTOS AL, MADEIRA F. A SIMPLE DEVICE FOR EXFOLIATIVE CYTOLOGY OF THE STOMACH. Gut. 1964 Apr;5(2):192-3. doi: 10.1136/gut.5.2.192. No abstract available. PMID 14159412