Clinical trial NCT06152783: Confocal Laser Microendoscopy (CellTouch) for the Diagnosis of Early Gastric Cancer: A Multicenter Clinical Study
Official title: Confocal Laser Microendoscopy (CellTouch) for the Diagnosis of Early Gastric Cancer: A Multicenter Clinical Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Early Gastric Cancer
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Wuxi Hisky Medical Technology Co Ltd
First posted: 2023-12-01
Enrollment: 578
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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).

Brief 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%.

Detailed 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.

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.

Primary outcomes:
measure: Histopathology was used as the diagnostic gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.
timeFrame: 30 min
Secondary outcomes:
measure: Using histopathology as the diagnostic gold standard, the diagnostic performance of CellTouch and ME-NBI in early gastric cancer was compared and analyzed.
timeFrame: 30 min
measure: 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.
timeFrame: 30 min
measure: 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.
timeFrame: 30 min
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital shanghai
name: zhen-dong jin, phD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.