Clinical trial · Interventional
Usefulness of Probe-based Confocal Laser Endo-microscopy in Delineation of Margin of Early Gastric Cancer for Endoscopic Submucosal Dissection
NCT02189226CI-TRIAL-00037869completedN/AClinicalTrials.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)
The aim of this study is to evaluate the usefulness of pCLE (probe-based confocal laser endomicroscopy) compared with conventional chromoendoscopy (CE) for delineating the margin of early gastric cancer (EGC) with endoscopic submucosal dissection (ESD).
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 |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- probe-based confocal laser endomicroscopy (pCLE) group
- interventionNames
- Device: Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE)
- type
- ACTIVE_COMPARATOR
- label
- chromoendoscopy (CE) group
- interventionNames
- Device: Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE)
Primary outcomes (1)
- measure
- Complete resection rate
- timeFrame
- One week after ESD
- description
- Complete resection is defined as en bloc resection with negative horizontal, vertical margin and distance from marking dot to histologic margin will be measured.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Consecutive patients diagnosed as EGC and treated by ESD with following criteria:1) Differentiated mucosal cancer without ulcer 2) Differentiated mucosal cancer with ulcer, ≤ 3 cm 3) Differentiated minute (\<500 μm) submucosal invasive cancer, ≤ 3 cm 4) Undifferentiated mucosal cancer without ulcer, ≤ 2 cm * Consecutive patients diagnosed as low- and high-grade dysplasia with suspicion of EGC and treated by ESD Exclusion Criteria: * Coagulopathy : International normalized ratio \[INR\] \> 1.5 or platelet count \<50,000 cell/cubic millimeter) * Impaired renal function : Cr \> 1.2 mg/dL * Pregnancy or breast-feeding * Age \< 20 years * Allergy to fluorescein dye * Inability to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.