A Randomized Prospective Comparison of the New EUS Guided Acquire TM Needle Biopsy vs EUS Guided Fine Needle Aspiration for Suspected Solid Gastrointestinal Lesions
Condition: Solid Tumor; Histological Type of Neoplasm
MeSH terms: Neoplasms by Histologic Type
Study type: Interventional

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.
    

Intervention name(s): Conventional EUS FNA needle; Acquire FNB device
Intervention type(s): Device; Device
Intervention description(s): 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
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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.
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: EUS; FNA; FNB; Core Histology