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

Early Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06152783
• Other study ID #: CH-2306
• Status: Not yet recruiting
• Start date: November 21, 2023
• Est. completion date: November 21, 2024

Study information

• Verified date: November 2023
• Source: Changhai Hospital
• Contact: wei an, doctor
• Phone: 13621719085
• Email: anweisusan[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is A prospective, randomized, multicenter clinical trial: The study intends to include subjects suspected of early gastric cancer, including 378 subjects with neoplastic lesions and 200 subjects with non-neoplastic lesions. The subjects are divided into two groups by random envelopes, A and B, and the endoscopic diagnosis in different groups is performed in different order (including: White light endoscopy,CellTouch, Magnifying endoscopy with NBI(ME-NBI)). Finally, the gold standard of histopathology was used to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.The study hypothesized that the sensitivity and specificity of CellTouch in the diagnosis of early gastric cancer could reach more than 90% and more than 95%.

Description:

Objectives:

1. Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.

Secondary Objectives

1. Using histopathology as the gold standard, the diagnostic performance of CellTouch and ME-NBI in the diagnosis of early gastric cancer was compared and analyzed.

2. Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch combined with ME-NBI and ME-NBI alone in the diagnosis of early gastric cancer.

3. Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch and ME-NBI in the differential diagnosis of low-grade intraepithelial neoplasia and high-grade intraepithelial neoplasia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 578
• Est. completion date: November 21, 2024
• Est. primary completion date: November 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Changhai Hospital	Wuxi Hisky Medical Technology Co Ltd

Country where clinical trial is conducted

China, 

References & Publications (4)

Han W, Kong R, Wang N, Bao W, Mao X, Lu J. Confocal Laser Endomicroscopy for Detection of Early Upper Gastrointestinal Cancer. Cancers (Basel). 2023 Jan 26;15(3):776. doi: 10.3390/cancers15030776. — View Citation

Pang S, Yao H, Jiang C, Zhang Q, Lin R. Confocal Laser Endomicroscopy Can Improve the Diagnosis Rate and Range Assessment of Patients With Conflicting Chronic Atrophic Gastritis Results of White Light Endoscopic and Pathological Diagnosis. Front Oncol. 2022 Mar 24;12:809822. doi: 10.3389/fonc.2022.809822. eCollection 2022. — View Citation

Pilonis ND, Januszewicz W, di Pietro M. Confocal laser endomicroscopy in gastro-intestinal endoscopy: technical aspects and clinical applications. Transl Gastroenterol Hepatol. 2022 Jan 25;7:7. doi: 10.21037/tgh.2020.04.02. eCollection 2022. — View Citation

Zhou YW, Zhang LY, Ding SN, Zhang AL, Zhu Y, Chen YX, Zhang QC, Sun LT, Yu JR. Hesitate between confocal laser endomicroscopy and narrow-band imaging: how to choose a better method in the detection of focal precancerous state of gastric cancer. Am J Transl Res. 2022 Jan 15;14(1):55-67. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histopathology was used as the diagnostic gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.	The diagnostic properties of CellTouch include: sensitivity and specificity.	30 min
Secondary	Using histopathology as the diagnostic gold standard, the diagnostic performance of CellTouch and ME-NBI in early gastric cancer was compared and analyzed.	Diagnostic performance related indexes include: accuracy, sensitivity, specificity, positive predictive value, negative predictive value.	30 min
Secondary	Using histopathology as the diagnostic gold standard, the diagnostic performance of CellTouch combined with ME-NBI and ME-NBI alone in early gastric cancer was compared and analyzed.	Diagnostic performance related indexes include: accuracy, sensitivity, specificity, positive predictive value, negative predictive value.	30 min
Secondary	Using histopathology as the diagnostic gold standard, the diagnostic performance of CellTouch and ME-NBI in the differential diagnosis of low-grade intraepithelial neoplasia and high-grade intraepithelial neoplasia was evaluated.	Diagnostic performance related indexes include: accuracy, sensitivity, specificity, positive predictive value, negative predictive value.	30 min