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

Not Applicable

• Conditions: Pancreatic Neoplasms
• Interventions: Device: needle punction

• Registration Number: NCT04877340
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief Summary

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.

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 Timeline

• Study Start: 2020-11-26
• Study First Submitted: 2021-04-20
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-03
• Last Update Submitted: 2021-05-03
• Study First Posted: 2021-05-07
• Last Update Posted: 2021-05-07
• Primary Completion: 2022-11
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Franseen 22G needle	needle punction	The pancreatic mass will be puncture, for expert endoscopist, with a FNB 22G needle. The sequence of the use of needles will be randomized.
Standard FNA 22G needle	needle punction	The pancreatic mass will be puncture, for expert endoscopist, with a standard FNA 22G needle

Primary Outcome Measures

Name	Time	Method
Compare the diagnostic yield	2 years	compare the diagnostic yield between two EUS needles

Secondary Outcome Measures

Name	Time	Method
adverse event rate	2 years	to assess the adverse event rate
extra passes with each needle	2 years	number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry
perform immunohistochemistry	2 years	need to perform immunohistochemistry to reach the result

Trial Locations

Locations (1)

ICESP; 🇧🇷 São Paulo, Sao Paulo, Brazil