Pancreatic Cancer, Solid Pancreatic and Peripancreatic Lesion
Conditions
Brief summary
To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.
Detailed description
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.
Interventions
DEVICE20-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.
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients who are at least 20 years of age * patients who require endoscopic ultrasound-guided fine needle aspiration cytology or biopsy because of pancreatic or peripancreatic solid mass.
Exclusion criteria
* Cystic pancreatic mass in imaging tests such as CT or MRI or US * haemodynamically unstable patients * severe coagulopathy (international normalized ratio \[INR\] \> 1.5 or platelet count \< 50,000 cells/cubic millimeter \[cmm3\]) * patients unable to quit anticoagulant/anti-platelet therapy * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procurement of the histologic core | 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 | 7 days after the procedure | \[Standard diagnosis\] * 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 7 days after the procedure | Technical failure is defined as malfunction of the needle before the investigators reached a diagnosis |
Countries
South Korea
Outcome results
None listed