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

NCT04509687 | Unknown

• 1 other identifier: ROSE
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The results of standard specimens-processing, microscope-operating training on endoscopists

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• age ≥18 years
• diagnosis or suspected of solid pancreatic mass based on previous imaging examination;
• EUS-FNA is achievable.
• signed informed consent letter

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 210000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

pancreatic sample acquired from EUS-FNA

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Shi-yu Li, M.D.

CONTACT

+8615521243639; lizfish@126.com

Kai-xuan Wang, Dr./M.D.

CONTACT

+8613585673477; wangkaixuan224007@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of the gastroenterology

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: December 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: November 1, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

CN (1)