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2016-07-11
2017-07-10
2017-07-10
30
NCT03017599
Yonsei University
Yonsei University
INTERVENTIONAL
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
To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-01-10 | N/A | 2018-05-17 |
2017-01-10 | N/A | 2018-05-22 |
2017-01-11 | N/A | 2018-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Intervention group EUS-FNB using 20-gauge procore needle | DEVICE: 20-gauge ProCore FNB needle
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Procurement of the histologic core | The sample quality is evaluated as optimal for histological evaluation; the presence of optimal histological core including recognizable structures | 7 days after the procedure |
| Diagnostic accuracy | [Standard diagnosis] * 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 | 7 days after the procedure |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Technical success | Technical failure is defined as malfunction of the needle before the investigators reached a diagnosis | 7 days after the procedure |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
