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

Yonsei University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer Solid Pancreatic and Peripancreatic Lesion

Interventions

20-gauge ProCore FNB needleDEVICE

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Severance Hospital, Yonsei University

Seoul, South Korea

Outcomes

Primary Outcomes

Procurement of the histologic core

The sample quality is evaluated as optimal for histological evaluation; the presence of optimal histological core including recognizable structures

Time frame: 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

Time frame: 7 days after the procedure

Secondary Outcomes

Technical success

Technical failure is defined as malfunction of the needle before the investigators reached a diagnosis

Time frame: 7 days after the procedure

Data from ClinicalTrials.gov

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