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Completed

NCT Number: NCT04975620

Comparison of Two Types of Biopsy Needles for EUS-FNB in Solid Pancreatobiliary Mass Lesions

EUS-guided tissue acquisition is an established modality to diagnose malignancies of the pancreas and extrahepatic bile ducts. In the recent years fine needle biopsy (FNB) needles have largely replaced fine needle aspiration (FNA) for EUS-guided tissue acquisition. The Acquire FNB needle is a Franseen needle which has three symmetric cutting edges to obtain core tissue specimens. The Trident FNB needle has been recently introduced to the market for EUS-guided tissue acquisition. It has a multi-blade three-prong tip which one of the tips is longer than the other two.

The aim of this study is to prospectively compare these two types of needle in term of diagnostic accuracy, and safety profile.

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Key information

Conditions

Pancreatic Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave.,

Tehran, 1411713135, Iran

About this study

Patients with solid mass lesions in the pancreas or extrahepatic biliary system will be randomly assigned to one of two types of FNB needle. Four passes of FNB will be acquired from the mass lesion in each patient. The primary aim is to compare sensitivity of two types of FNB needle to diagnose malignancy. Also, each pass of FNB needle will be assessed separately by two expert pathologists to determine per-pass sensitivity of two types of FNB needles.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inpatients and outpatients 18 years of age or older with solid mass lesions in the pancreas or extrahepatic biliary system

Exclusion criteria

  • Uncorrectable coagulopathy (INR > 1.5)
  • Uncorrectable thrombocytopenia (platelet < 50,000)
  • Decline to participate in the study and sign the informed consent form
  • Cystic lesions.

Treatment and study plan

Fine needle biopsy

Device

Taking biopsy from solid pancreatobiliary mass lesions with 8 back and forth movement of the needle within the lesion with slow withdrawal of the stylet

Primary outcomes

  1. Comparison of EUS-FNB sensitivity using two types of FNB needles

    Time frame: 6 months

    Comparison of EUS-FNB sensitivity using two types of FNB needles

Secondary outcomes

  1. Comparing per-pass sensitivity in two types of FNB needles

    Time frame: 6 months

    Comparing per-pass sensitivity in two types of FNB needles

  2. Comparing the adequacy of specimen for each pass in two types of FNB needles

    Time frame: 6 months

    Comparing the adequacy of specimen for each pass in two types of FNB needles

  3. Comparing the rate of core tissue acquisition for each pass in two types of FNB needles

    Time frame: 6 months

    Comparing the rate of core tissue acquisition for each pass in two types of FNB needles

  4. Comparing specimen cellularity for each pass in two types of FNB needles

    Time frame: 6 months

    Comparing specimen cellularity for each pass in two types of FNB needles

  5. Comparing the score of blood content n for each pass in two types of FNB needles.

    Time frame: 6 months

    Comparing the score of blood content n for each pass in two types of FNB needles. (The blood content is scored from 1 to 3 in which 1 represents minimal presence of blood in the specimen).

Sponsors and collaborators

Lead sponsor

University of Tehran

Other

Registry information

Official study title

Comparison of Two Types of Biopsy Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) in Solid Pancreatobiliary Mass Lesions

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 23, 2021
Registry last updated
May 16, 2023

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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