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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03109639
• Date of registration: 01/04/2017
• Prospective Registration: Yes
• Primary sponsor: Singapore General Hospital
• Public title: A Randomized Prospective Comparison of the New EUS Guided Acquire TM Needle Biopsy vs EUS Guided Fine Needle Aspiration for Suspected Solid Gastrointestinal Lesions
• Scientific title: A Randomized Prospective Comparison of the New EUS Guided Acquire TM Needle Biopsy vs EUS Guided Fine Needle Aspiration for Suspected Solid Gastrointestinal Lesions
• Date of first enrolment: April 13, 2017
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03109639
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Singapore

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age older than 21 years

2. All patients with solid lesions (pancreas, lymph nodes, metastasis, liver and
sub-epithelial lesions) referred for EUS- FNA

3. Solid lesions confirmed by at least a single investigational modality, mainly CT, MRI
or endoscopy

4. Able to comply with the study procedure and provide informed consent.

Exclusion Criteria:

1. Presence of active bleeding

2. Presence of coagulopathy as evidenced by INR>1.5 and platelets <50,000

3. Inability to sample because of intervening blood vessels seen during imaging or EUS.

4. Poor patient tolerance to procedure

5. Concurrent intake of anti-coagulants and thienopyridine (e.g clopidogrel) in patients
who require anti-platelet therapy.

6. Pregnancy



Age minimum: 21 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Histological Type of Neoplasm

Solid Tumor

Intervention(s)

Device: Conventional EUS FNA needle

Device: Acquire FNB device

Primary Outcome(s)

Tissue adequacy rate will be measured by assessing for the presence of histological core tissue representative of the lesion in the samples obtained using the two needles [Time Frame: 8 months]

Secondary Outcome(s)

Qualification of the sample obtained using the two needles will be performed by spectroscopic analysis.The ratio of absorbance at 260 nm and 280nm; the ratio of absorbance at 260nm and 230nm will be measured [Time Frame: 8 months]

Quantification of the sample obtained using the two EUS needles will be assessed by measuring the DNA and RNA concentration [Time Frame: 8 months]

Secondary ID(s)

EUS01042017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors