Diagnostic Efficacy of FFOCT Imaging for Tissue Sample Obtained by EUSFNB

Comparing of FFOCT Imaging for Pancreatic Tissue Sample Obtained by EUSFNB and Conventional Histological Examination

In most Asian medical centers, rapid on-site cytology evaluation is not available, the number of needle passes of EUS-FNA is decided by endoscopists. Full-field optical coherence tomography (FF-OCT) is a new optical imaging technique that could generate sectioning tomogram from fresh tissue and provide close-to-pathology depiction of the morphological structure and pathological changes in minutes without conventional tissue preparation, slicing, and staining, and dynamic cell imaging (DCI) added the viability information of cells/tissue, which could be more important in sample rapid evaluation.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Diseases
• Intervention / Treatment: Device: full-field optical coherence tomography

Detailed Description

Light-CT, a special-designed pathology-approximation system which is based on the lighting feature or dynamic feature of tissue and cells, is used to detect malignant cells or tissue in fresh specimens. Morphological structure and pathological changes could be captured in minutes, which implies a possible application in intraoperative diagnosis. The investigators aimed to evaluate the diagnostic efficacy of FFOCT for the tissue samples obtained from EUS-FNB of pancreas.

• Study Type: Observational
• Enrollment (Anticipated): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients with pancreatic diseases who receive EUS-FNA/B with tissue sample obtained will be enrolled in the study

Description

Inclusion Criteria:

• Tissue samples can be obtained via EUS-FNB
• Signed informed consent letter

Exclusion Criteria:

• Unable or refuse to provide informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of Light-CT	The true positive rate measures the proportion of positives that are correctly identified by Light-CT	1week after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of Light-CT	The true negative rate measures the proportion of positives that are correctly identified by Light-CT	1week after procedure
The diagnostic efficacy of Light-CT for different pancreatic diseases	Comparing the sensitivity and specificity of FFOCT in the diagnosis of different pancreatic diseases	1week after procedure
coherence of FFOCT diagnoses by assistant and pathologist	comparing the diagnostic coherence of FFOCT by trained assistant( endoscopist) and trained pathologist	1week after procedure

Collaborators and Investigators

• Sponsor: Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: FFOCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No