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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04153318
Enrollment
80
Registered
2019-11-06
Start date
2019-12-01
Completion date
2020-07-01
Last updated
2019-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Diseases

Brief 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.

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.

Interventions

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.

Sponsors

Changhai Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Unable or refuse to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of Light-CT1week after procedureThe true positive rate measures the proportion of positives that are correctly identified by Light-CT

Secondary

MeasureTime frameDescription
Sensitivity of Light-CT1week after procedureThe true negative rate measures the proportion of positives that are correctly identified by Light-CT
The diagnostic efficacy of Light-CT for different pancreatic diseases1week after procedureComparing the sensitivity and specificity of FFOCT in the diagnosis of different pancreatic diseases
coherence of FFOCT diagnoses by assistant and pathologist1week after procedurecomparing the diagnostic coherence of FFOCT by trained assistant( endoscopist) and trained pathologist

Contacts

Primary ContactWei Zhou, M.D.
zhou_wei0012@163.com+8618021009362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026