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

NCT03109639 | Completed DMC FDA Device

• 1 other identifier: EUS01042017
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumor; Histological Type of Neoplasm

Keywords

EUS; FNA; FNB; Core Histology

Outcome Measures

Primary Outcomes (1)

• 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

  The samples will be analyzed by the blinded pathologist for presence of histological core. Based on the presence of histological core, the sample will be graded optimal or suboptimal. Optimal specimens are those in which the procured material enabled satisfactory assessment of histologic architecture. Suboptimal specimens are those in which the quality of the core is inadequate or unsatisfactory for the assessment of histologic architecture

  8 months

Secondary Outcomes (2)

• Quantification of the sample obtained using the two EUS needles will be assessed by measuring the DNA and RNA concentration

  8 months

• 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

  8 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

This group will undergo tissue acquisition using the conventional EUS-FNA needle followed by the experimental Acquire EUS- FNB needle

Device: Conventional EUS FNA needle; Device: Acquire FNB device

Group B

ACTIVE COMPARATOR

This group will undergo tissue acquisition using the experimental Acquire EUS- FNB needle followed by the conventional EUS-FNA needle

Device: Conventional EUS FNA needle; Device: Acquire FNB device

Interventions

Conventional EUS FNA needle DEVICE

Participants randomised to Group A will undergo tissues acquisition using the Conventional EUS FNA needle and then crossed over to receive the experimental Acquire EUS- FNB device.

Group A; Group B

Acquire FNB device DEVICE

Participants randomised to Group B will undergo tissue acquisition using the experimental Acquire EUS FNB device and then crossed over to receive the conventional EUS FNA needle

Group A; Group B

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 21 years
• All patients with solid lesions (pancreas, lymph nodes, metastasis, liver and sub-epithelial lesions) referred for EUS- FNA
• Solid lesions confirmed by at least a single investigational modality, mainly CT, MRI or endoscopy
• Able to comply with the study procedure and provide informed consent.

You may not qualify if:

• Presence of active bleeding
• Presence of coagulopathy as evidenced by INR\>1.5 and platelets \<50,000
• Inability to sample because of intervening blood vessels seen during imaging or EUS.
• Poor patient tolerance to procedure
• Concurrent intake of anti-coagulants and thienopyridine (e.g clopidogrel) in patients who require anti-platelet therapy.
• Pregnancy

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Neoplasms by Histologic Type

Condition Hierarchy (Ancestors)

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The pathologist will be blinded to the needle used for specimen collection.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants will be randomised to one of the two groups. The first group will undergo tissue acquisition using the conventional EUS needle. After this, the lesion will be punctured again using the experimental Acquire EUS FNB needle to obtain tissue. In the second group, the experimental Acquire EUS FNB needle will be used first followed by the conventional needle to acquire tissue.

Study Record Dates

• First Submitted: April 1, 2017
• First Posted: April 12, 2017
• Study Start: April 13, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)