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

NCT ID: NCT04509687

Last Updated: 2020-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

chief of the gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shi-yu Li, M.D.

Role: CONTACT

+8615521243639

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

Role: CONTACT

+8613585673477

Facility Contacts

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Zhen-dong Jin, Ph.D

Role: primary

13901618837

Other Identifiers

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ROSE

Identifier Type: -

Identifier Source: org_study_id

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