Comparison of a Novel 22-gauge Core Biopsy Needle

Brief summary public domain (ClinicalTrials.gov)

The goal of this clinical research study is to compare the performance of a newly available needle with reverse bevel design (called the EchoTip® Procore™ needle) with standard needles to see which needle gives better diagnostic information for pancreatic lesions.

Detailed description public domain (ClinicalTrials.gov)

An endoscopic ultrasound-guided needle biopsy or FNA is a special endoscopic procedure used to sample lesions within or next to the digestive tract, including the pancreas. The needle is used to collect material for diagnosis. A special lighted, flexible tube called an endoscope is inserted through the mouth, into the stomach and small intestine. The endoscope also has an ultrasound probe at its tip which can be used to see the pancreas, which is located behind the stomach. The doctor will then use the ultrasound to guide the needle biopsy or FNA. In this procedure, an average of 4 needle passes (needle sticks) is needed to collect enough tissue for diagnosis. However, the number of passes can be higher or lower, depending on the individual lesion and success of the needle passes. If participant agrees to take part in this study, 2 different needles (the standard straight hollow-core needle and the new EchoTip® Procore™ needle) will be used to sample the pancreas lesion. Two (2) passes will be performed with each needle type and compared. If additional passes are needed for diagnosis, they will not be included in this study. After the first set of needle passes, the doctor may decide that more passes are needed. Final test results will be taken from the diagnostic results from each needle pass. The results from both types of the needle will be included in the participant's medical record. This is an investigational study. All needles used in this study are FDA approved and commercially available. Comparing the needles is investigational. Up to 60 participants will take part in this study. All will be enrolled at MD Anderson.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. [Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes.]. Count Of Participants, Participants. All pancreas masses: Score 0 or 1: Standard Suction Technique (SST) Cytology (n=29): 5; Capillary Suction Technique (CST) (n=30): 6. All pancreas masses: Score 2 or 3: Standard Suction Technique (SST) Cytology (n=29): 24; Capillary Suction Technique (CST) (n=30): 24. All pancreas masses: Score 3: Standard Suction Technique (SST) Cytology (n=29): 23; Capillary Suction Technique (CST) (n=30): 21. Adenocarcinoma: Score 0 or 1: Standard Suction Technique (SST) Cytology (n=29): 4; Capillary Suction Technique (CST) (n=30): 5. Adenocarcinoma: Score 2 or 3: Standard Suction Technique (SST) Cytology (n=29): 18; Capillary Suction Technique (CST) (n=30): 18. Adenocarcinoma: Score 3: Standard Suction Technique (SST) Cytology (n=29): 17; Capillary Suction Technique (CST) (n=30): 17.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle. [Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes]. Count Of Participants, Participants. All pancreas masses: Score 0 or 1: Standard Suction Technique (SST) Histology (n=27): 8; Capillary Suction Technique (CST) Histology (n=29): 9. All pancreas masses: Score 2 or 3: Standard Suction Technique (SST) Histology (n=27): 19; Capillary Suction Technique (CST) Histology (n=29): 20. Adenocarcinoma: Score 0 or 1: Standard Suction Technique (SST) Histology (n=27): 5; Capillary Suction Technique (CST) Histology (n=29): 8. Adenocarcinoma: Score 2 or 3: Standard Suction Technique (SST) Histology (n=27): 15; Capillary Suction Technique (CST) Histology (n=29): 14.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis [Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes]. Count Of Participants, Participants. All pancreas masses: Score 2 or 3: 22G Procore Needle (n=59): 48; Standard 25G Needle (n=60): 57. All pancreas masses: Score 3: 22G Procore Needle (n=59): 44; Standard 25G Needle (n=60): 45. Adenocarcinoma: Score 2 or 3: 22G Procore Needle (n=59): 36; Standard 25G Needle (n=60): 43. Adenocarcinoma: Score 3: 22G Procore Needle (n=59): 34; Standard 25G Needle (n=60): 34.