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Diagnostic Efficacy of FFOCT Imaging for Tissue Sample Obtained by EUSFNB

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ClinicalTrials.gov Identifier: NCT04153318
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

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.

Condition or disease Intervention/treatment
Pancreatic Diseases 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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Comparing of FFOCT Imaging for Pancreatic Tissue Sample Obtained by EUSFNB and Conventional Histological Examination
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Sensitivity of Light-CT [ Time Frame: 1week after procedure ]
    The true positive rate measures the proportion of positives that are correctly identified by Light-CT


Secondary Outcome Measures :
  1. Sensitivity of Light-CT [ Time Frame: 1week after procedure ]
    The true negative rate measures the proportion of positives that are correctly identified by Light-CT

  2. The diagnostic efficacy of Light-CT for different pancreatic diseases [ Time Frame: 1week after procedure ]
    Comparing the sensitivity and specificity of FFOCT in the diagnosis of different pancreatic diseases

  3. coherence of FFOCT diagnoses by assistant and pathologist [ Time Frame: 1week after procedure ]
    comparing the diagnostic coherence of FFOCT by trained assistant( endoscopist) and trained pathologist



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable or refuse to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153318


Contacts
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Contact: Wei Zhou, M.D. +8618021009362 zhou_wei0012@163.com

Sponsors and Collaborators
Changhai Hospital

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Responsible Party: Zhaoshen Li, chief of the Gastroenterology, Changhai Hospital
ClinicalTrials.gov Identifier: NCT04153318     History of Changes
Other Study ID Numbers: FFOCT
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases