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A Non-Inferiority Study of 0.8% Lugol's Iodine Staining versus 1.5% for the Detection of Esophageal Epithelial Neoplasia

A Non-Inferiority Study of 0.8% Lugol's Iodine Staining versus 1.5% for the Detection of Esophageal Epithelial Neoplasia - A Non-Inferiority Study of 0.8% Lugol's Iodine Staining versus 1.5% for the Detection of Esophageal Epithelial Neoplasia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058239
Enrollment
353
Registered
2025-07-01
Start date
2025-08-01
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

Esophageal Squamous Cell Carcinoma

Interventions

During esophagogastroduodenoscopy for esophageal cancer screening and surveillance, participants will undergo iodine staining with 1.5% iodine solution. During esophagogastroduodenoscopy for esophagea

Sponsors

Hokkaido University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals who are predicted in advance to require iodine staining during esophagogastroduodenoscopy for esophageal cancer screening or surveillance, based on being at high risk for esophageal cancer Individuals who have received a full explanation of the study, fully understood its contents, and voluntarily agreed to participate by providing written informed consent

Exclusion criteria

Exclusion criteria: Individuals with an allergy to iodine Individuals diagnosed with advanced esophageal cancer (those with a history of esophageal cancer may be included if the cancer has been cured) Individuals with esophageal cancer of a histological type other than squamous cell carcinoma Individuals who are unable to undergo biopsy Individuals who have undergone iodine staining within the past month Individuals who have undergone surgery involving the esophagus Individuals who are deemed unsuitable for participation in the study by the principal investigator for any other reason

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of 0.8% iodine staining compared to 1.5% iodine staining for superficial esophageal squamous cell carcinoma

Countries

Japan

Contacts

Public ContactMasaki Inoue

Hokkaido University Hospital Division of Endoscopy

mokomokomomon@gmail.com011-716-1161

Outcome results

None listed

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