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

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Shi-yu Li, M.D.; Phone Number: +8615521243639; Email: lizfish@126.com
• Study Contact Backup: Name: Kai-xuan Wang, Dr./M.D.; Phone Number: +8613585673477; Email: wangkaixuan224007@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 210000
      • Recruiting
      • Changhai Hospital
      • Contact: Zhen-dong Jin, Ph.D; Phone Number: 13901618837; Email: zhendjin@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We plan to involve 60 patients with solid pancreatic lesion, with trained endoscopists performing ROSE in the procedure of EUS-FNA

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ROSE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No