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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052220032
Enrollment
4000
Registered
2022-05-27
Start date
2022-06-01
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

upper gastrointestinal epithelial tumor upper gastrointestine, epithelial tumor

Interventions

Randomly assign patients to "Group A for WLI and LCI" or "Group B for LCI alone" for endoscopy.
endoscopy, randomize, LCI, WLI

Sponsors

Dohi Osamu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with gastric epithelial tumors detected

Secondary

MeasureTime frame
Percentage of holders of gastric epithelial tumorsdetected in prior WLI observation (Group A) and LCI observation (Group B) Percentage of patients with epithelial gastrictumor detected in group A and group B at the second endoscopy Percentage of patients with epithelial tumor detected of pharynx and esophagus in WLI observation (group A) and LCI observation (group B) Observation time (total observation timeexcluding treatment time by each mode, and observation time by site) Presence of serious adverse events Diagnostic accuracy of epithelial tumors (diagnostic accuracy of epithelial tumors relative to the number of biopsies by mode) Percentage of lesions of gastric epithelial tumors by years of experience (expert and non-expert) Percentage of lesions of gastric epithelial tumors by endoscope scope (fine diameter and other) Percentage of lesions of gastric epithelial tumors by light source (laser/LED)

Contacts

Public ContactKazuyo Futahasi

University Hospital Kyoto Prefectural University of Medicine

futahasi@koto.kpu-m.ac.jp+81-75-251-5650

Outcome results

None listed

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