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Comparison of full-field optical coherence tomography imaging for pancreatic tissue sample obtained by EUS-fine-needle biopsy and conventional histological examination: A study protocol for a prospective trial


1 Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China
2 Department of Gastroenterology, Affiliated Hospital of Nantong University, Nantong University, Nantong, Jiangsu, China

Correspondence Address:
Kai-Xuan Wang,
Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, No. 168, Changhai Road, Yangpu District, Shanghai 200433
China
Zhen-Dong Jin,
Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, No. 168, Changhai Road, Yangpu District, Shanghai 200433
China
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/eus.eus_27_20

PMID: 32952130

For a definitive diagnosis of fine-needle aspiration (FNA)/biopsy, one of the reliable techniques to determine the adequacy and accuracy rapid on-site evaluation (ROSE) of cytological samples is preferable. Because of the lack of trained pathologists, alternatives have to be explored. This study is primarily conducted to determine the diagnostic sensitivity and specificity of full-field optical coherence tomography (FF-OCT) and secondarily to evaluate the possibility of FF-OCT differentiating different types of pancreatic diseases. The diagnostic coherence of FF-OCT by a trained assistant (endoscopist) and trained pathologist is also compared. This is a single-center, prospective, observation trial. Eighty patients would be enrolled in the study. The tissue samples acquired by endoscopic ultrasound fine-needle biopsy (EUS-FNB) would be imaged by the FF-OCT system, interpreted by a trained endoscopist and a pathologist. The results of the image interpretation would be verified with histological findings. This study determines the diagnostic capability of FF-OCT as a ROSE technique while performing EUS-FNB, and whether endoscopists can implement the assessment.


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