Solid Tumor Clinical Trial
Official 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
Verified date | March 2020 |
Source | Singapore General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | November 30, 2017 |
Est. primary completion date | November 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 99 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Quantification of the sample obtained using the two EUS needles will be assessed by measuring the DNA and RNA concentration | 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 | |
Secondary | 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 | 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 |
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