Comparing the Diagnostic Efficacy of Different Suction Techniques for EUS-FNB of Pancreatic Solid Lesions
NCT ID: NCT04100941
Last Updated: 2019-09-24
Study Results
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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UNKNOWN
NA
300 participants
INTERVENTIONAL
2019-06-10
2020-11-30
Brief Summary
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Detailed Description
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slow-pull : after the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward.
wet suction: after removing the stylet, the needle was flushed with 5mL of saline solution to replace the column of air with saline. A 10mL syringe was attached to the end of the needle. 20 times of for-backward Suction was applied after the lesion was punctured.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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standard suction
This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the standard suction technique with 10ml negative pressure
standard suction
After the needle is inserted in the mass, removing the stylet before performing EUS-FNA. Then attach a 10mL syringe to the end of needle. 20 times of for-backward Suction was applied after the lesion was punctured.
slow pull
This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique
slow pull
After the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward.
wet suction
This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique
wet suction
After removing the stylet, the needle was flushed with 5mL of saline solution to replace the column of air with saline. A 10mL syringe was attached to the end of the needle. 20 times of for-backward Suction was applied after the lesion was punctured.
Interventions
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standard suction
After the needle is inserted in the mass, removing the stylet before performing EUS-FNA. Then attach a 10mL syringe to the end of needle. 20 times of for-backward Suction was applied after the lesion was punctured.
slow pull
After the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward.
wet suction
After removing the stylet, the needle was flushed with 5mL of saline solution to replace the column of air with saline. A 10mL syringe was attached to the end of the needle. 20 times of for-backward Suction was applied after the lesion was punctured.
Eligibility Criteria
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Inclusion Criteria
2. diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI)
3. lesion diameter larger than 1 cm
4. signed informed consent letter
Exclusion Criteria
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/μL,international normalized ratio \> 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-FNB
18 Years
75 Years
ALL
No
Sponsors
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Shenzhen People's Hospital
OTHER
The Affiliated Hospital Of Southwest Medical University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
chief of the Gastroenterology
Principal Investigators
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Zhao-shen Li, M.D.,Ph.D.
Role: STUDY_CHAIR
Changhai Hospital
Locations
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Changhai Hospital, Second Military Medical University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EUS-FNB 25G
Identifier Type: -
Identifier Source: org_study_id
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