Abstract:Objective To evaluate the diagnostic utility of a domestically produced needle-based confocal laser endoscopy (nCLE) system guided by endoscopic ultrasonography (EUS) for gastrointestinal and adjacent tumors. Methods In this prospective study, patients with radiologically identified gastrointestinal or peri-intestinal tumors at Wuhan Fourth Hospital from June to November 2024 underwent EUS-guided puncture with a 19-gauge needle, followed by nCLE probe insertion for real-time imaging. Histological specimens was obtained by concurrent EUS-guided fine-needle aspiration/biopsy (EUS-FNA/FNB), whilst any complication during the procedure was monitored. The final clinical diagnosis integrated surgical pathology, EUS-FNA/FNB pathological results and imaging findings. Results Among the 10 patients included in the study, nCLE diagnoses included 2 cases of pancreatic serous cystic neoplasm, 1 case of pancreatic mucinous cystic neoplasm with intraepithelial neoplasia, 1 case of intraductal papillary mucinous neoplasm, 1 case of pancreatic inflammatory lesion, and 5 cases of malignant lesions. The final clinical diagnoses were 2 cases of pancreatic serous cystic neoplasm, 1 pancreatic mucinous cystic neoplasm, 1 pancreatic tuberculosis, 2 intraductal papillary mucinous neoplasm (1 with malignant transformation), 1 pancreatic ductal adenocarcinoma with peritoneal metastasis, 1 cholangiocarcinoma with hilar lymph node metastasis, 1 pulmonary squamous cell carcinoma with mediastinal lymph node metastasis, and 1 colonic adenocarcinoma. The nCLE diagnostic findings were consistent with the final clinical diagnoses in all patients. One patient developed intracystic bleeding after the nCLE and EUS-FNA procedures, resolved without intervention. Conclusion EUS-guided domestically produced nCLE is safe and effective in the diagnosis of gastrointestinal and peripheral tumors, demonstrating promising clinical applicability.