- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Singapore, Singapore, 169608
- Singapore General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A
This group will undergo tissue acquisition using the conventional EUS-FNA needle followed by the experimental Acquire EUS- FNB 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.
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
|
Active Comparator: Group B
This group will undergo tissue acquisition using the experimental Acquire EUS- FNB needle followed by the 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.
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantification of the sample obtained using the two EUS needles will be assessed by measuring the DNA and RNA concentration
Time Frame: 8 months
|
Both cell block and core biopsies will be deparafinized and extraction with Qiagen RNA/ DNA kit will be performed.
Both DNA and RNA will be quantified by Qubit system
|
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
Time Frame: 8 months
|
Spectroscopic analysis will be performed to assess the purity samples.
The 260/280 and 260/230 ratios will be measured.
A lower ratio may indicate the presence of impurities.
|
8 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EUS01042017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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