Yield Rate for Procurement the Histologic Core With Endoscopic Ultrasound-guided Fine Needle Biopsy With 20-gauge Ultrasound Biopsy Needles for Solid Pancreatic Masses: Pilot Study
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|ClinicalTrials.gov Identifier: NCT03017599|
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : May 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Solid Pancreatic and Peripancreatic Lesion||Device: 20-gauge ProCore FNB needle||Not Applicable|
Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis.
Regarding the diagnosis of pancreatic cancer, proper tool with high diagnostic yield is very important. The investigators investigated the technical feasibility and diagnostic yield of recent-developed new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.
The investigators applied the 20-gauge procore needle for EUS-guided fine needle biopsy in the diagnosis of pancreatic solid mass. A total of 30 patients will be enrolled for the present pilot study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||July 11, 2016|
|Actual Primary Completion Date :||July 10, 2017|
|Actual Study Completion Date :||July 10, 2017|
Experimental: Intervention group
EUS-FNB using 20-gauge procore needle
Device: 20-gauge ProCore FNB needle
The investigators will prospectively collect data base including patients who underwent EUS-guided biopsy with the 20-gauge ProCore histology needle for the evaluation of Pancreatic solid mass.
EUS procedures will be performed under sedation with linear echoendoscopes. Once the lesion will be penetrated, the stylet will be removed, and suction will be applied for 10 to 20 seconds by using a 10-ml syringe while moving the needle to and fro. All samples will processed at the pathology departments for histological analysis with documentation.
Other Name: 20G Echotip ProCore Fine Needle Biopsy (FNB) device(Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
- Procurement of the histologic core [ Time Frame: 7 days after the procedure ]The sample quality is evaluated as optimal for histological evaluation; the presence of optimal histological core including recognizable structures
- Diagnostic accuracy [ Time Frame: 7 days after the procedure ]
- In operated patients; based on the surgical resection specimen
- In non-operated patients; based on the conclusions of the diagnostic work-up and confirmed by a compatible clinical disease course
- Technical success [ Time Frame: 7 days after the procedure ]Technical failure is defined as malfunction of the needle before the investigators reached a diagnosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017599
|Korea, Republic of|
|Severance Hospital, Yonsei University|
|Seoul, Korea, Republic of, 03722|