Confocal Laser Microendoscopy (CellTouch) for the Diagnosis of Early Gastric Cancer: A Multicenter Clinical Study
NCT ID: NCT06152783
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
578 participants
OBSERVATIONAL
2023-11-21
2024-11-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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A group
The sequence of endoscopy in group A was as follows: white light endoscopy, ME-NBI endoscopy,Confocal laser endomicroscopy.
No interventions assigned to this group
B group
The sequence of endoscopy in group B was as follows: white light endoscopy, Confocal laser endomicroscopy, ME-NBI endoscopy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Wuxi Hisky Medical Technology Co Ltd
INDUSTRY
Changhai Hospital
OTHER
Responsible Party
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Principal Investigators
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zhen-dong jin, phD
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital shanghai
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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CH-2306
Identifier Type: -
Identifier Source: org_study_id