Pancreatic DiseasesNCT04153318
Diagnostic Efficacy of FFOCT Imaging for Tissue Sample Obtained by EUSFNB
An observational study of Pancreatic Diseases, run by Changhai Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Diseases
- What is being tested?
- full-field optical coherence tomography
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients with pancreatic diseases who receive EUS-FNA/B with tissue sample obtained will be enrolled in the study
Who may be able to join
- Tissue samples can be obtained via EUS-FNB
- Signed informed consent letter
Who cannot join
- Unable or refuse to provide informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparing of FFOCT Imaging for Pancreatic Tissue Sample Obtained by EUSFNB and Conventional Histological Examination
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.
Read the 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.
- Conditions
- Pancreatic Diseases
- Being tested
- full-field optical coherence tomography
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full-field optical coherence tomographyDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Light-CT
The true positive rate measures the proportion of positives that are correctly identified by Light-CT
Measured: 1week after procedure
Secondary outcomes (3)
Sensitivity of Light-CT
The true negative rate measures the proportion of positives that are correctly identified by Light-CT
Measured: 1week after procedure
The diagnostic efficacy of Light-CT for different pancreatic diseases
Comparing the sensitivity and specificity of FFOCT in the diagnosis of different pancreatic diseases
Measured: 1week after procedure
coherence of FFOCT diagnoses by assistant and pathologist
comparing the diagnostic coherence of FFOCT by trained assistant( endoscopist) and trained pathologist
Measured: 1week after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic DiseasesStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153318
- Sponsor's protocol ID
- FFOCT
- Status last verified
- Nov 2019
- First submitted
- 4 Nov 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing of FFOCT Imaging for Pancreatic Tissue Sample Obtained by EUSFNB and Conventional Histological Examination
- ClinicalTrials.gov ID
- NCT04153318
- Acronym / sponsor ID
- FFOCT
- Conditions
- Pancreatic Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients with pancreatic diseases who receive EUS-FNA/B with tissue sample obtained will be enrolled in the study
Key inclusion criteria (2 listed)
- Tissue samples can be obtained via EUS-FNB
- Signed informed consent letter
Key exclusion criteria (1 listed)
- Unable or refuse to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| full-field optical coherence tomographyPancreatic 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. | Device | – |
Primary outcome
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
3 secondary outcomes
Sensitivity of Light-CT
Time frame: 1week after procedure
The diagnostic efficacy of Light-CT for different pancreatic diseases
Time frame: 1week after procedure
coherence of FFOCT diagnoses by assistant and pathologist
Time frame: 1week after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Diseases, run by Changhai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhou, M.D. (+8618021009362, zhou_wei0012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Light-CT (time frame: 1week after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.