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
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