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Completed

NCT Number: NCT03017599

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

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

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Solid Pancreatic and Peripancreatic Lesion

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital, Yonsei University

Seoul, 03722, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

20-gauge ProCore FNB needle

Device

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.

Other names: 20G Echotip ProCore Fine Needle Biopsy (FNB) device(Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)

Primary outcomes

  1. Procurement of the histologic core

    Time frame: 7 days after the procedure

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

  2. Diagnostic accuracy

    Time frame: 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 outcomes

  1. Technical success

    Time frame: 7 days after the procedure

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2017
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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