Pancreatic CancerEUS-FNANCT04509687
Training Endoscopists to Perform On-site Rapid Cytological Evaluation for EUS-FNA of Solid Pancreatic Lesions
An observational study of Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
In China, there is a serious shortage of pathologists who can perform on-site cytological diagnosis. As a result, there are few centers that can conduct ROSE in China, which limits the diagnostic accuracy of EUS-FNA to a certain extent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 1 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We plan to involve 60 patients with solid pancreatic lesion, with trained endoscopists performing ROSE in the procedure of EUS-FNA
Who may be able to join
- age ≥18 years
- diagnosis or suspected of solid pancreatic mass based on previous imaging examination;
- EUS-FNA is achievable.
- signed informed consent letter
Who cannot join
- pregnant female
- pancreatic cystic lesions
- anticoagulant/antiplatelet therapy cannot be suspended
- unable or refuse to provide informed consent
- coagulopathy (platelet count <50 ×103/uL, international normalized ration >1.5）
- severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia
- with history of mental disease
- other medical conditions that are not suitable for EUS-FNA
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 210000
Zhen-dong Jin, Ph.D, 13901618837, zhendjin@126.com
About this study
Official title: Feasibility Study of Training Endoscopists to Perform On-site Rapid Cytological Evaluation for Endoscopic Ultrasound-guided Fine-needle Aspiration of Solid Pancreatic Lesions
In China, there is a serious shortage of pathologists who can perform on-site cytological diagnosis. As a result, there are few centers that can conduct ROSE in China, which limits the diagnostic accuracy of EUS-FNA to a certain extent. Previous research reports on whether endoscopists could be trained for ROSE were controversial, which may be related to the lack of standardization of the training of endoscopists. There is no training program for training endoscopists to systematically process pathological specimens, operate microscopes, read the adequacy of cytological specimens, and evaluate the atypia of cytological specimens in China. Therefore, our center intends to carry out a training for endoscopists to compare the improvement of endoscopists' ROSE operating ability before and after the training, and to evaluate the practice of each endoscopist to perform on-site rapid cytology specimens of solid pancreatic lesions.
- Conditions
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of endoscopists for interpretation of cytologic specimen adequacy and primary diagnosis of malignancy
The interpretation results of endoscopists will be compared with that of cytopathologist.
Measured: 10 months
Secondary outcomes (1)
The results of standard specimens-processing, microscope-operating training on endoscopists
Comparison of the score that endoscopists are graded before and after the standard training
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Dec 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 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
- NCT04509687
- Sponsor's protocol ID
- ROSE
- Acronym
- EUS-FNA
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 12 Aug 2020
- 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 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Training Endoscopists to Perform On-site Rapid Cytological Evaluation for Endoscopic Ultrasound-guided Fine-needle Aspiration of Solid Pancreatic Lesions
- ClinicalTrials.gov ID
- NCT04509687
- Acronym / sponsor ID
- EUS-FNA / ROSE
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 12 Aug 2020 (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 China, there is a serious shortage of pathologists who can perform on-site cytological diagnosis. As a result, there are few centers that can conduct ROSE in China, which limits the diagnostic accuracy of EUS-FNA to a certain extent. Previous research reports on whether endoscopists could be trained for ROSE were controversial, which may be related to the lack of standardization of the training of endoscopists. There is no training program for training endoscopists to systematically process pathological specimens, operate microscopes, read the adequacy of cytological specimens, and evaluate the atypia of cytological specimens in China. Therefore, our center intends to carry out a training for endoscopists to compare the improvement of endoscopists' ROSE operating ability before and after the training, and to evaluate the practice of each endoscopist to perform on-site rapid cytology specimens of solid pancreatic lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to involve 60 patients with solid pancreatic lesion, with trained endoscopists performing ROSE in the procedure of EUS-FNA
Key inclusion criteria (4 listed)
- age ≥18 years
- diagnosis or suspected of solid pancreatic mass based on previous imaging examination;
- EUS-FNA is achievable.
- signed informed consent letter
Key exclusion criteria (8 listed)
- pregnant female
- pancreatic cystic lesions
- anticoagulant/antiplatelet therapy cannot be suspended
- unable or refuse to provide informed consent
- coagulopathy (platelet count <50 ×103/uL, international normalized ration >1.5）
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of endoscopists for interpretation of cytologic specimen adequacy and primary diagnosis of malignancy
Time frame: 10 months
The interpretation results of endoscopists will be compared with that of cytopathologist.
1 secondary outcome
The results of standard specimens-processing, microscope-operating training on endoscopists
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
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 4 inclusion and 8 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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Shi-yu Li, M.D. (+8615521243639, lizfish@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of endoscopists for interpretation of cytologic specimen adequacy and primary diagnosis of malignancy (time frame: 10 months). 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 12 Aug 2020.