Clinical trial · Interventional
Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma
Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma: A Multicenter, Randomized, Controlled Trial
- 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)
i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol. ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield. iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric IM/IN/CA.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Carcinoma | Gastric Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Intestinal Metaplasia | — | UNRESOLVED | — |
| Gastric Intraepithelial Neoplasia | Gastric Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Confocal laser endomicroscopy (Pentax, EG3870K) | Device | — | UNRESOLVED |
| Standard White-light endoscopy (Pentax, 90i) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CLE-TB
- description
- Confocal laser endomicroscopy with Targeted Biopsy
- interventionNames
- Device: Confocal laser endomicroscopy (Pentax, EG3870K)
- type
- EXPERIMENTAL
- label
- WLE-SB
- description
- Standard White-light endoscopy with Standard Biopsy
- interventionNames
- Device: Standard White-light endoscopy (Pentax, 90i)
Primary outcomes (1)
- measure
- number of participant with gastric IM/IN/CA
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Male or Female aged 18-80 * Patients with H. pylori infection, or histologically verified gastric intestinal metaplasia, low-grade intraepithelial neoplasia, and atrophic gastritis Exclusion Criteria: * Patients with gastrectomy, acute GI bleeding, and advanced gastric cancer * Patients under conditions unsuitable for performing CLE including coagulopathy, impaired renal function, pregnancy or breastfeeding, and known allergy to fluorescein sodium * Inability to provide informed consent and other situations that could interfere with the examination protocol
References
Publications (0)
Data not yet available