Usefulness of confocal laser endomicroscopy in delineation of margin of gastric epithelial tumors with endoscopic submucosal dissection

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000934

Enrollment

Registered

2013-11-22

Start date

2013-11-18

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Before performing endoscopic resection for gastric epithelial tumor, the delineation of tumor margin is determined based on the findings of chromoendoscopy in the control group and th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with histologic confirmation of gastric cancer and following conditions as: i) Differentiated histologic type, mucosal cancer, no ulcer, irrespective of size ii) Differentiated histologic type, mucosal cancer, presence of ulcer, size = 30 mm iii)Differentiated histologic type, minute submucosal depth of invasion (= 500 µm), no ulcer, size = 30 mm iv) Undifferentiated histologic type, mucosal cancer, no ulcer, size = 20 mm 2. Patients with histologic confirmation of gastric adenoma 3. Patients with therapeutic plan of endoscopic resection for gastric epithelial tumors which met the above criteria

Exclusion criteria

Exclusion criteria: 1. Patients who refuse the informed consent 2. Patients who cannot undergo endoscopic submucosal dissection due to substantial bleeding tendency 3. Patients with known allergy history with fluororescin 4. Patients with chronic renal failure 5. Patients with pregancy or breast-feeding

Design outcomes

Primary

Measure	Time frame
Complete resection	—

Secondary

Measure	Time frame
Distance from margin of gastric epithelial tumor to CLE-guided margin marking	—

Countries

Korea, Republic of

Contacts

Public ContactJun Chul Park

Yonsei University Health System, Severance Hospital

Outcome results