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

JRCT ID: jRCTs052220032

Registered date:27/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: upper gastrointestinal epithelial tumor
• Date of first enrollment: 01/06/2022
• Target sample size: 4000
• Study type: Interventional
• Intervention(s): Randomly assign patients to "Group A for WLI and LCI" or "Group B for LCI alone" for endoscopy.

Outcome(s)

• Primary Outcome: Proportion of patients with gastric epithelial tumors detected

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 89age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Dohi Osamu
• Source(s) of Monetary Support: FUJIFILM Corporation