Comparing the Diagnostic Adequacy of 25-gauge Fork-tip, Franseen and Reverse-bevel Type Needles in Endoscopic Ultrasound Guided Tissue Acquisition

Biopsy, Needle Clinical Trial

Official title:

A Prospective Randomized Study Comparing the Diagnostic Adequacy of 25-gauge Fork-tip, Franseen and Reverse-bevel Type Needles in Endoscopic Ultrasound Guided Tissue Acquisition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05434247
• Other study ID #: LNR/QMS/44303
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: June 2022
• Source: Princess Alexandra Hospital, Brisbane, Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) and fine needle biopsy (EUS-FNB) are well established techniques for the acquisition of tissue to classify a number of lesions of the gastrointestinal tract and surrounding organs. These include pancreatic, lymphoid, subepithelial and other abdominal lesions. Historically, FNA was the sole available modality used to obtain cytological samples for analysis. The major shortcoming of this technique is the lack of a histological tissue core.

In recent years attention has turned to optimizing needle design to improve sample quality. New needles have been developed which aim to obtain a core of tissue with preserved architecture.

These needles include the first generation Reverse-bevel Echo Tip® HD ProCore™ (Wilson-Cook Medical Inc., Winston-Salem, NC, United States), and the second generation Fork-tip SharkCore™ (Medtronic Inc., Sunnyvale, CA, United States) and Franseen Acquire™ (Boston Scientific, Marlborough, MA, United States).

Currently there are a paucity of studies comparing the performance of these needles, and only two of these are prospective randomized controlled trials. Real world performance of these needles has seldom been reported, with only one RCT including non-pancreatic masses in their analysis.

The investigators hypothesize that second generation needles have equivalent or better diagnostic performance than the prior first-generation needle.

To test this, the investigators aim to conduct a prospective randomized controlled study comparing the performance of Fork-tip and Franseen needles for the sampling of pancreatic, subepithelial, lymphoid and other abdominal or mediastinal lesions. They also aim to include a retrospective control arm of consecutive cases using the first-generation Reverse-bevel needle.

The investigatora aim to assess the diagnostic yield of each needle, as well as number of needle passes used, and specimen quality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Any solid tissue biopsy performed at the time of endoscopic ultrasound

Exclusion Criteria:

• Fluid samples were excluded.

• Cases where biopsy was not deemed necessary by the proceduralist based on endosonographic findings

• Cases where biopsy was deemed unsafe

Related Conditions & MeSH terms

• Biopsy, Needle

Intervention

Device:
• Needle choice
The type of needle use was the only intervention

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Princess Alexandra Hospital, Brisbane, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		At end of study medical record review, approximately 1 year after final subject enrolled
Primary	Diagnostic yield	The percentage of lesions sampled for which a tissue diagnosis was obtained	At study completion, approximately 1 year after final subject enrolled
Secondary	Number of needle passes		At study completion, approximately 1 year after final subject enrolled
Secondary	Sample bloodiness	A subjective assessment of the amount of blood seen on histopathological specimens (1 = no interference with interpretation, 2 = interference with interpretation but diagnosis can still be made, 3 = excessive blood makes assessment impossible)	At study completion, approximately 1 year after final subject enrolled
Secondary	Target tissue cellularity	Subjective assessment by histopathologist of the cellularity of the sample (consisting of cells from the target lesion) - low, medium or high.	At study completion, approximately 1 year after final subject enrolled