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Clinical Trials/JPRN-jRCTs052220032
JPRN-jRCTs052220032RecruitingPhase 3

inked color imaging-Endoscopy for upper gastrointestinal Tumor Surveillance: A multi-center randomized trial - LET'S trial

Dohi Osamu0 sites4,000 target enrollmentStarted: May 27, 2022Last updated:

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
4,000

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to <= 89age old (—)
Sex
All

Inclusion Criteria

  • Patients who meet all of the following criteria willbe included
  • 1) Patients with previous pharyngeal, esophageal, or gastric epithelial tumors (after endoscopic treatment, radiotherapy, or chemotherapy) or untreated lesions described above undergoing follow-up and scheduled for surveillance endoscopy.
  • 2) Patients without upper gastrointestinal epithelial lesions (head and neck, esophagus, stomach) to be treated.
  • 3) Patients must be at least 20 years old and less than 89 years old (as of the date of enrollment).
  • 4) Written consent has been obtained from the patient prior to enrollment in the study.

Exclusion Criteria

  • Patients who fall into any of the following categories will not be included in this study.
  • 1. Patients with a history of surgical resection of the upper gastrointestinal tract .
  • 2. Patients who are in poor general condition and are expected to have difficulty in endoscopy after one year.
  • 3. Patients with severe comorbidities with a predicted prognosis of less than one year.
  • 4. Patients with any of the following complications
  • 1. Severe infection or organ failure
  • 2. Carcinoma undergoing chemotherapy or radiation therapy
  • 3. Bleeding tendency due to thrombocytopenia or abnormal blood coagulation disease
  • 5. Patients for whom biopsy is deemed impossible due to antithrombotic medication.
  • 6. Pregnant or lactating women.
  • 7. Patients who are judged by the principal investigator or sub-investigator to be inappropriate for participation in this study for other safety reasons.

Investigators

Sponsor
Dohi Osamu

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