NCT03561038

Comparing the Franseen and Fork-top Needles for EUS-guided Fine-needle Biopsy of Solid Mass Lesions.

Randomized Trial Comparing the Franseen and Fork-top Needles for EUS-guided Fine-needle Biopsy of Solid Mass Lesions.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This will be a randomized controlled trial of all the patients referred to University of Arkansas Medical for Medical Sciences (UAMS) for endoscopic ultrasound (EUS) guided biopsy of solid mass lesions. EUS guided tissue acquisition will be performed in all these patients using both needle types (22-gauge Franseen Fine Needle Biopsy (FNB) (Acquire, Boston Scientific Corporation, Natick, Mass) and 22-gauge Fork-tip FNB needle (SharkCore, Medtronic)) with randomization of the order in which the needle will be used.

Detailed description

All procedures will be performed by the advance endoscopists Dr Sumant Inamdar (SI) and Dr Benjamin Tharian (BT) using a linear array echoendoscope (Olympus UCT180, Olympus America Corp, Center Valley, Pa) with patients in the left lateral decubitus position after administration of anesthesia (propofol or general anesthesia). During EUS, the mass will first be punctured using either needle based on the randomization assignment. Tissue acquisition will be performed using the fanning maneuver (4 strokes at 4 different locations within the mass). After performing 2 dedicated passes for cell block for histological analysis using the randomized needle, 2 additional passes will be made for cell block with the alternate needle. Sample obtained from each pass is placed into a separate container to be analysed separately. The occurrence of immediate adverse events will be noted at the time of procedure, and late adverse events will be documented by follow-up telephone calls at 1 week post-procedure

Conditions

• Solid Mass Lesions in GI Tract

Interventions

Type	Name	Description
DEVICE	Franseen Needle	Comparing 2 needles designed for tissue acquisition
DEVICE	Fork-tip Needle	Comparing 2 needles designed for tissue acquisition

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2018-06-19
• Last updated: 2024-09-03