NCT03109639

A Randomized Prospective Comparison of the New EUS Guided Acquire TM Needle Biopsy vs EUS Guided Fine Needle Aspiration for Suspected Solid Gastrointestinal Lesions

Completed NA Last updated 19 March 2020

What this trial tests

NA trial testing Conventional EUS FNA needle in Solid Tumor in 36 participants. Completed in 30 November 2017.

Timeline

13 April 2017

Primary endpoint
30 November 2017

30 November 2017

Quick facts

Lead sponsor	Singapore General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	diagnostic
Enrollment	36
Start date	13 April 2017
Primary completion	30 November 2017
Estimated completion	30 November 2017
Sites	1 location across Singapore

Drugs / interventions tested

• Conventional EUS FNA needle
• Acquire FNB device

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →
• Histological Type of Neoplasm — all drugs for Histological Type of Neoplasm →

Sponsor

Singapore General Hospital

Who can join

Adults 21 to 99, any sex, with Solid Tumor or Histological Type of Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) is the technique of choice to evaluate solid gastrointestinal (GI) lesions. The tissue acquired using this technique is essential for diagnosis of diseases like sub-mucosal masses (GIST), lymphoma, autoimmune pancreatitis and pancreatic cancer. Also the availability of adequate tissue will enable performance of molecular profiling and personalized oncologic therapy. The current needle used for tissue acquisition rarely provides tissue blocks needed for histology assessment. Hence, a better needle device with a good safety profile is needed to solve this technical difficulty. The new AcquireTM fine needle biopsy device could over come this difficulty because of its unique designs. The additional cutting edge surface allows better tissue access and provides core tissue (\>90%) for histology. The safety profile of this new device is comparable to the conventional FNA needle thereby making it an ideal device for tissue acquisition.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of tissue and molecular yield between fine-needle biopsy (FNB) and fine-needle aspiration (FNA): a randomized study.
   Asokkumar R, Yung Ka C, Loh T, Kah Ling L, et al · · 2019 · cited 68× · PMID 31367675 · DOI 10.1055/a-0903-2565