Diagnostic Efficacy of FFOCT Imaging for Tissue Sample Obtained by EUSFNB

NCT ID: NCT04153318

Last Updated: 2019-11-06

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unable or refuse to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

chief of the Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Wei Zhou, M.D.

Role: CONTACT

+8618021009362

Other Identifiers

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FFOCT

Identifier Type: -

Identifier Source: org_study_id

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