Clinical trial · Interventional
Role of Probe-based Confocal Laser Endomicroscopy Targeted Biopsy in the Molecular Study of Undifferentiated Gastric Cancer
- 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)
The purpose of this study is to conduct a study on genetic pathology, obtaining of pure cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or less. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. In previous pilot study in our institution, pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with undifferentiated histology. However, there was a limitation because of small sample size. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer cells and expression ratio of tumor marker in biopsy samples.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Undifferentiated Gastric Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France | Device | — | UNRESOLVED |
| white light endoscopy (WLE) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- pCLE group
- description
- The intervention group
- interventionNames
- Device: GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France
- type
- ACTIVE_COMPARATOR
- label
- WLE group
- description
- The control group
- interventionNames
- Device: white light endoscopy (WLE)
Primary outcomes (1)
- measure
- The percentage of cancer cells in biopsy samples
- timeFrame
- Day 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: A. Age, between 20 and 80 B. Patients with undifferentiated gastric cancer who will be underwent surgery Exclusion Criteria: A. Previous subtotal gastrectomy B. Previous EMR/ESD history C. Significant cardiopulmonary disease D. Active hepatitis or severe hepatic dysfunction E. Severe renal dysfunction F. Severe bone marrow dysfunction G. Severe neurologic or psychotic disorder H. Pregnancy or breast feeding
References
Publications (0)
Data not yet available