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

Feasibility Study of Training Endoscopists to Perform On-site Rapid Cytological Evaluation for Endoscopic Ultrasound-guided Fine-needle Aspiration of Solid Pancreatic Lesions

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04509687

Acronym

EUS-FNA

Enrollment

Registered

2020-08-12

Start date

2019-12-01

Completion date

2020-11-01

Last updated

2020-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of endoscopists for interpretation of cytologic specimen adequacy and primary diagnosis of malignancy	10 months	The interpretation results of endoscopists will be compared with that of cytopathologist.

Secondary

Measure	Time frame	Description
The results of standard specimens-processing, microscope-operating training on endoscopists	3 months	Comparison of the score that endoscopists are graded before and after the standard training

Countries

China

Contacts

Primary ContactShi-yu Li, M.D.

lizfish@126.com+8615521243639

Backup ContactKai-xuan Wang, Dr./M.D.

wangkaixuan224007@163.com+8613585673477

Outcome results