Ignite Creation Date:
2024-05-06 @ 1:13 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01769248
Status:
COMPLETED
Last Update Posted:
2018-01-18
First Post:
2013-01-10
Brief Title:
Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUCIN
Brief Summary:
Endoscopic ultrasound EUS is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract EUS allows for the acquisition of cellular fine needle aspirate - FNA or tissue biopsy fine needle biopsy - FNB for diagnostic purposes This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis More recently a needle that allows a tissue biopsy for histologic analysis has been FDA approved
The Echotip Procore Cook Medical core biopsy needle ETP has been demonstrated to provide excellent efficacy for core biopsy samples Final diagnostic yield using this needle ranges from 80-90 and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis However there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle The investigators propose a randomized prospective cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB
The Echotip Procore Cook Medical core biopsy needle ETP has been demonstrated to provide excellent efficacy for core biopsy samples Final diagnostic yield using this needle ranges from 80-90 and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis However there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle The investigators propose a randomized prospective cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB
Detailed Description:
Endoscopic ultrasound EUS is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract EUS allows for the acquisition of cellular fine needle aspirate - FNA or tissue biopsy fine needle biopsy - FNB for diagnostic purposes This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis More recently a needle that allows a tissue biopsy for histologic analysis has been FDA approved
We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140 patients with the primary outcome being diagnostic yield Each patient will be randomized to FNA or FNA If after 3 passes the on-site evaluation remains inadequate the endoscopist will crossover to the other arm
We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140 patients with the primary outcome being diagnostic yield Each patient will be randomized to FNA or FNA If after 3 passes the on-site evaluation remains inadequate the endoscopist will crossover to the other arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None