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

Phase 3

Recruiting

• Conditions: upper gastrointestinal epithelial tumor; upper gastrointestine, epithelial tumor

• Registration Number: JPRN-jRCTs052220032
• Lead Sponsor: Dohi Osamu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 4000

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified