Confocal Laser Microendoscopy (CellTouch) for the Diagnosis of Early Gastric Cancer: A Multicenter Clinical Study

Launched by CHANGHAI HOSPITAL · Nov 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new method called Confocal Laser Microendoscopy, or CellTouch, to help doctors diagnose early gastric cancer more accurately. The trial will involve around 578 people who have been found to have suspicious lesions in their stomachs during a previous examination. These lesions could be early signs of cancer or non-cancerous growths. Participants will be randomly assigned to different groups to compare how well CellTouch works against other methods like standard endoscopy (a procedure where a small camera is inserted to look inside the stomach). Researchers hope that CellTouch will show very high accuracy in identifying early gastric cancer.

To be eligible for this study, participants need to be between 18 and 70 years old and have had suspicious lesions found during a gastroscopy, which is a procedure to examine the stomach. Participants should be willing to provide written consent to take part in the study. However, those with advanced gastric cancer, certain medical conditions, or who are pregnant or breastfeeding cannot join. If you participate, you can expect to undergo some tests using the CellTouch method and will help researchers understand its effectiveness in diagnosing early gastric cancer. The trial is not yet recruiting participants, so those interested will need to wait for the study to begin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged between 18 and 70 years;
• • 2. Patients who have recently found suspicious lesions by gastroscopy and need further intensive examination;(Suspicious lesions refer to suspected superficial neoplastic lesions visible under white light endoscopy, including elevation type, flatness type and depression type. According to the Paris classification standard);
• • 3. Patients who willing to provide written informed consent.
• Exclusion Criteria:
• • 1. Patients with absolute contraindications to gastroscopy;
• • 2. Patients with advanced gastric cancer;
• • 3. Patients who cannot undergo histopathological examination;
• • 4. Patients who cannot be given general anesthesia;
• • 5. Patients who are pregnant or lactating patients, or prepare to conceive or who are at risk of conception due to lack of effective contraception；
• • 6. Patients with history of drug allergies, such as anesthetics, fluorescein sodium, bowel preparation drugs, etc.