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Pathological evaluation of the intestinal tract with confocal laser endomicroscopy

Pathological evaluation of the intestinal tract with confocal laser endomicroscopy - Pathological evaluation of the intestinal tract with confocal laser endomicroscopy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009759
Enrollment
100
Registered
2013-02-01
Start date
2013-02-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

GI epithelial lesions

Interventions

Transvenous administration of 10% solution or topical application of 0.1% fluorescein solution will be performed for tissue visualization with CLE. Then, the studied sites will be biopsied and the spe

Sponsors

Department of Endoscopy The Jikei University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with suspected digestive disease such as a gastric carcinoma, gastric adenoma, colon carcinoma, colon adenoma.

Exclusion criteria

Exclusion criteria: 1) Patients not indicated for normal endoscopy 2) History of allergy to fluorescein dye 3) Subjects with a severe comorbidity such as a diabetic disease, cardiovascular, neurologic dysfunction, cirrhosis of the liver, pheochromocytoma and pregnancy.

Design outcomes

Primary

MeasureTime frame
The procedural success rate of the visualization of the structure.

Secondary

MeasureTime frame
1) Comparing CLE findings with normal endoscopic findings, magnifying-endoscopic findings and pathological findings 2) Differential diagnosis 3) Image quality assessment. The evaluation criteria are divided into three(poor, almost invisible tissue structure; mild, visible tissue structure with too dark vision; good, clearly visible tissue structure). 4) Adverse events

Countries

Japan

Contacts

Public ContactMasakuni Kobayashi

The Jikei University School of Medicine Department of Endoscopy

masakuni@jikei.ac.jp03-3433-1111(ext.3181)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026