Diagnostic Efficacy of FFOCT Imaging for Tissue Sample Obtained by EUSFNB

Pancreatic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04153318
• Other study ID #: FFOCT
• Status: Not yet recruiting
• Start date: December 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: November 2019
• Source: Changhai Hospital
• Contact: Wei Zhou, M.D.
• Phone: +8618021009362
• Email: zhou_wei0012[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Tissue samples can be obtained via EUS-FNB

• Signed informed consent letter

Exclusion Criteria:

• Unable or refuse to provide informed consent

Related Conditions & MeSH terms

• Pancreatic Diseases

Intervention

Device:
• full-field optical coherence tomography
Pancreatic tissue sample obtained by EUS-FNB will be used for FFOCT imaging. The Images will be sent to trained pathologists for diagnosis. The same tissue sample will be sent to the pathology department for routine histological examination. Compare the diagnoses made by the 2 different methods.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of Light-CT	The true positive rate measures the proportion of positives that are correctly identified by Light-CT	1week after procedure
Secondary	Sensitivity of Light-CT	The true negative rate measures the proportion of positives that are correctly identified by Light-CT	1week after procedure
Secondary	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
Secondary	coherence of FFOCT diagnoses by assistant and pathologist	comparing the diagnostic coherence of FFOCT by trained assistant( endoscopist) and trained pathologist	1week after procedure