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

NCT ID: NCT03109639

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-13
• Study Completion Date: 2017-11-30

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.

Detailed Description

Endoscopic ultrasound has become the preferred method to characterise gastrointestinal (GI) wall and peri-gastrointestinal masses. A major strength is that it can be used to guide fine needle aspiration (EUS-FNA) of any lesion in the wall or within 5cm from the GI tract. However, EUS-FNA has a major drawback- it rarely able to provide tissue blocks. Thus multiple passes, each of them time consuming, are necessary to obtain adequate cellular samples for cytological analysis. A radically new design of FNA needle (AcquireTM) has recently become available. The needle has an additional cutting edge surface, which allows better tissue access and acquires intact large core samples. The flexibility of the needle permits its use in tortuous anatomy, thereby making it an ideal needle for FNA. The new AcquireTM fine needle biopsy device (FNB) provides core tissue (>90%) for histology. This ability of the needle will enable us to obtain core tissue in fewer passes and make a precise diagnosis. However, at present there is no prospective randomized study to validate this finding.

The investigators hypothesize that the unique cutting system of Acquire TM fine needle biopsy (FNB) device will improve the specimen adequacy of solid intestinal and extra-intestinal lesions by providing a good core tissue for analysis.

Conditions

Solid Tumor; Histological Type of Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

Conventional EUS FNA needle

Intervention Type: 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.

Acquire FNB device

Intervention Type: 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 B

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

Group Type: ACTIVE_COMPARATOR

Conventional EUS FNA needle

Intervention Type: 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.

Acquire FNB device

Intervention Type: 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

Interventions

Conventional EUS FNA needle

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.

Intervention Type: DEVICE

Acquire FNB 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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Singapore General Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

EUS01042017

Identifier Type: -

Identifier Source: org_study_id