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

Not Applicable

Completed

• Conditions: Pancreatic Cancer; Solid Pancreatic and Peripancreatic Lesion
• Interventions: Device: 20-gauge ProCore FNB needle

• Registration Number: NCT03017599
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2016-07-11
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-11
• Primary Completion: 2017-07-10
• Study Completion: 2017-07-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	20-gauge ProCore FNB needle	EUS-FNB using 20-gauge procore needle

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Technical success	7 days after the procedure	Technical failure is defined as malfunction of the needle before the investigators reached a diagnosis

Trial Locations

Locations (1)

Severance Hospital, Yonsei University; 🇰🇷 Seoul, Korea, Republic of