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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02327065
Other study ID # 2014tj1212
Secondary ID
Status Recruiting
Phase N/A
First received December 11, 2014
Last updated December 29, 2014
Start date December 2014
Est. completion date May 2016

Study information

Verified date December 2014
Source Huazhong University of Science and Technology
Contact Bin Cheng, Doctor
Phone 86-027-8366-3333
Email bcheng@tjh.tjmu.edu.cn
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the diagnosis accuracy of FNA and FNB biopsy on pancreatic, retroperitoneal, mediastinum and pelvic cavity solid occupying lesions.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic


Intervention

Device:
EUS-FNA (EchoTip Ultra)
FNA,Fine needle aspiration
EUS-FNB (EchoTip ProCore)
FNB,Fine needle biopsy

Locations

Country Name City State
China Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (9)

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Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic Yield on malignancy The investigators' primary outcome measure is to compare the the diagnostic yield (%) on malignancy of EUS-FNA to EUS-FNB 18 months No
Secondary Blood contamination and cellularity in specimens obtained by EUS-FNA and EUS-FNB with Slow-pull or suction The amount of blood contamination and cellularity at each sample according to EUS-FNA and EUS-FNB with slow-pull or suction will be measured. 18 months No
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