Training Endoscopists to Perform On-site Rapid Cytological Evaluation for EUS-FNA of Solid Pancreatic Lesions

Pancreatic Cancer Clinical Trial

— EUS-FNA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04509687
• Other study ID #: ROSE
• Status: Recruiting
• Start date: December 1, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: August 2020
• Source: Changhai Hospital
• Contact: Shi-yu Li, M.D.
• Phone: +8615521243639
• Email: lizfish[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 1, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age =18 years

2. diagnosis or suspected of solid pancreatic mass based on previous imaging examination;

3. EUS-FNA is achievable.

4. signed informed consent letter

Exclusion Criteria:

1. pregnant female

2. pancreatic cystic lesions

3. anticoagulant/antiplatelet therapy cannot be suspended

4. unable or refuse to provide informed consent

5. coagulopathy (platelet count <50 ×103/uL, international normalized ration >1.5)

6. severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia

7. with history of mental disease

8. other medical conditions that are not suitable for EUS-FNA

Related Conditions & MeSH terms

• Pancreatic Cancer

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 months
Secondary	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	3 months