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
1 other identifier
observational
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2019
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedNovember 6, 2019
November 1, 2019
2 months
November 4, 2019
November 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity of Light-CT
The true positive rate measures the proportion of positives that are correctly identified by Light-CT
1week after procedure
Secondary Outcomes (3)
Sensitivity of Light-CT
1week after procedure
The diagnostic efficacy of Light-CT for different pancreatic diseases
1week after procedure
coherence of FFOCT diagnoses by assistant and pathologist
1week after procedure
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.
Eligibility Criteria
All consecutive patients with pancreatic diseases who receive EUS-FNA/B with tissue sample obtained will be enrolled in the study
You may qualify if:
- Tissue samples can be obtained via EUS-FNB
- Signed informed consent letter
You may not qualify if:
- Unable or refuse to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief of the Gastroenterology
Study Record Dates
First Submitted
November 4, 2019
First Posted
November 6, 2019
Study Start
December 1, 2019
Primary Completion
February 1, 2020
Study Completion
July 1, 2020
Last Updated
November 6, 2019
Record last verified: 2019-11