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

Pancreatic Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017599
• Other study ID #: 4-2016-0429
• Status: Completed
• Phase: N/A
• Start date: July 11, 2016
• Est. completion date: July 10, 2017

Study information

• Verified date: May 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 10, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Solid Pancreatic and Peripancreatic Lesion

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Lee JH, Stewart J, Ross WA, Anandasabapathy S, Xiao L, Staerkel G. Blinded prospective comparison of the performance of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of the pancreas and peri-pancreatic lesions. Dig Dis Sci. 2009 Oct;54(10):2274-81. doi: 10.1007/s10620-009-0906-1. Epub 2009 Aug 11. — View Citation

Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Technical success	Technical failure is defined as malfunction of the needle before the investigators reached a diagnosis	7 days after the procedure