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Multicenter cohort study to investigate the risk of metachronous multiple cancers and assess the period required for their development after EMR, using Lugol-voiding pattern as a biomarker in patients with esophageal squamous cell carcinoma

Multicenter cohort study to investigate the risk of metachronous multiple cancers and assess the period required for their development after EMR, using Lugol-voiding pattern as a biomarker in patients with esophageal squamous cell carcinoma - Follow up study after EMR for esophageal squamous cell carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001676
Enrollment
330
Registered
2009-01-31
Start date
2005-09-01
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

At study entry, patients will be instructed to abstain from smoking and drinking alcohol.

Sponsors

Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Newly diagnosed early squamous cell carcinoma of the esophagus. (2) Complete endoscopic resection as assessed visually on Lugol chromoendoscopy immediately after EMR. (3) A diagnosis of squamous cell carcinoma on histopathological examination of the resected specimen. (4) Vertical margins of the resected specimen are confirmed to be tumor-negative. (5) Tumor invasion is limited to the mucosa on histopathological examination of the resected specimen, and no additional treatment (surgical resection, radiotherapy, chemotherapy, etc.) is performed immediately after EMR. (6) No active head or neck cancers. (7) The investigator judges that patient can be observed for at least 2 years. (8) Written informed consent is obtained from the patient.

Exclusion criteria

Exclusion criteria: (1) A history of chemotherapy for any other cancers or a history of surgical treatment or radiotherapy for head and neck cancers. (2) A history of iodine allergy. (3) Patients whom the investigator considers unsuitable as subjects for this study.

Design outcomes

Primary

MeasureTime frame
The cumulative incidence of metachronous multiple cancers of the esophagus as assessed by the Lugol-voiding pattern.

Secondary

MeasureTime frame
1) The total annual number of cases of metachronous multiple cancer of the esophagus as assessed by the Lugol-voiding pattern. 2) The cumulative incidence of metachronous multiple cancers of the head and neck region as assessed by the Lugol-voiding pattern.

Countries

Japan

Contacts

Public ContactChikatoshi Katada

Kitasato University Hospital Department of Gastroenterology

ckatada@med.kitasato-u.ac.jp042-778-8111

Outcome results

None listed

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