Clinical Trial: Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB and EUS-FNA on Solid Occupying Lesion

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB（Endoscopic Ultrasonography-Fine Needle Biopsy ） and EUS-FNA（Endoscopic Ultrasonography-Fine Needl

Brief 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.

Detailed Summary:

The study subjects are divided into two groups: the EUS-FNA(22G EchoTip Ultra needles) Group and EUS-FNB group(22G EchoTip ProCore needles).Take the malignant occupying lesion diagnosis accuracy as the research major indicator to compare the EUS-FNB group and EUS-FNA group as optimal efficiency test. Take the class I error a=0.05, class II error β=0.15, power=0.85. Suppose the malignancy diagnosis accuracy is 80%, while that of FNB is 93%. The two trial groups be randomly allocated in 1:1, suppose the malignancy cases take 70% of the whole case, and considering the shedding factors , extra 20% cases should be included. So the estimated cases numbers is 204 cases for EUS-FNB group and 204 cases for EUS-FNA group, totally 408 cases in this trial.

Done by professional statistical people with randomized block grouping method and SAS 9.2 statistical software to generate randomized serial number（001—408）for the two groups in 1:1 manner. The serial numbers are the randomized grouping numbers for the trial patients, block capacity is 8, totally 51 randomized block. The randomized grouping will be generated in duplicate copies and sealed. One copy send to trial centers for patient allocating, and the another copy be saved by the trial applicant unit. Every trail centers will be responsible for the screening of qualified patients, rank them in visit time to get the randomized grouping number so as to determine them goes to the EUS-FNA or EUS-FNB.The research people and patients in all trial centers should not know the the randomized grouping number and relevant groups. The group name will be sealed under scratch card. Every trial patients will get a unique randomized number, and it will not change through out the whole trial.

Use the inclusion and exclusion criteria to observe the patients and do relative in
Sponsor: Huazhong University of Science and Technology

Current Primary Outcome: Diagnostic Yield on malignancy [ Time Frame: 18 months ]

The investigators' primary outcome measure is to compare the the diagnostic yield (%) on malignancy of EUS-FNA to EUS-FNB


Original Primary Outcome: Same as current

Current Secondary Outcome: Blood contamination and cellularity in specimens obtained by EUS-FNA and EUS-FNB with Slow-pull or suction [ Time Frame: 18 months ]

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.


Original Secondary Outcome: Same as current

Information By: Huazhong University of Science and Technology

Dates:
Date Received: December 11, 2014
Date Started: December 2014
Date Completion: May 2016
Last Updated: December 29, 2014
Last Verified: December 2014