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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

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Yonsei University

Status

Completed

Conditions

Solid Pancreatic and Peripancreatic Lesion
Pancreatic Cancer

Treatments

Device: 20-gauge ProCore FNB needle

Study type

Interventional

Funder types

Other

Identifiers

NCT03017599
4-2016-0429

Details and patient eligibility

About

To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.

Full 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.

Enrollment

30 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Intervention group
Experimental group
Description:
EUS-FNB using 20-gauge procore needle
Treatment:
Device: 20-gauge ProCore FNB needle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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