Comparation Between Needles for EUS-guided Sampling of Solid Pancreatic Lesions

May 3, 2021 updated by: Instituto do Cancer do Estado de São Paulo

Prospective Randomized Study Comparing the 25-gauge Franseen Needle and the 25-gauge Standard Needle for EUS-guided Fine-needle Sampling of Solid Pancreatic Lesions Without Rapid on Site Evaluation

This is a randomized study in order to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized trial conducted at a unique center. The aim of this study is to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.

Patients with a suspected solid pancreatic lesion larger than 15 mm, identified by CT or MRI and referred to EUS-guided sampling will be eligible for inclusion. Patients will be excluded in case of cystic lesion, or the lesion was not detected in EUS, or if the coagulation parameters are abnormal (INR> 2, platelet count < 50,000). The pancreatic mass will be puncture, for expert endoscopist, firstly with a needle according to randomization, followed by another one. Will be make a touch print with the specimen obtained with the needles and, subsequently, all the specimen will be put in formaldehyde solution for cell-block analysis.

Diagnostic yield of cell block will be defined as enough histologic tissue core containing pancreatic parenchyma or tumor with dysplastic cells enough for the correct tissue diagnosis. In the presence of malignant tissue in core specimens, it will be calculated the proportion of the area positive for malignancy compared to the total area of the core and then the each needle yield will be defined.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01246-000
        • Recruiting
        • ICESP
        • Contact:
          • ICESP
        • Principal Investigator:
          • FAUZE MALUF-FILHO, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- solid pancreatic lesion larger than 15 mm

Exclusion Criteria:

  • pancreatic cystic lesion
  • lesion not detected in EUS
  • abnormal coagulation parameters (INR> 2, platelet count < 50,000)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard FNA 22G needle
The pancreatic mass will be puncture, for expert endoscopist, with a standard FNA 22G needle
Device: needle punction
EUS-guided sampling of pancreatic solid lesions obtained with the 22-gauge
Experimental: Franseen 22G needle
The pancreatic mass will be puncture, for expert endoscopist, with a FNB 22G needle. The sequence of the use of needles will be randomized.
Device: needle punction
EUS-guided sampling of pancreatic solid lesions obtained with the 22-gauge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the diagnostic yield
Time Frame: 2 years
compare the diagnostic yield between two EUS needles
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
extra passes with each needle
Time Frame: 2 years
number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry
2 years
perform immunohistochemistry
Time Frame: 2 years
need to perform immunohistochemistry to reach the result
2 years
adverse event rate
Time Frame: 2 years
to assess the adverse event rate
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: FAUZE MALUF-FILHO, PHD, ICESP/FMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2020

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26962419.3.0000.0065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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