| Primary | Diagnostic Yield of Capillary Technique | Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained. | | Posted | | Number | | percentage of specimen | | up to 6 months | | | | ID | Title | Description |
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| OG000 | Capillary Technique | These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously. Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously |
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| Primary | Diagnostic Yield of Standard Technique | Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained. | | Posted | | Number | | percentage of specimen | | up to 6 months | | | | ID | Title | Description |
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| OG000 | Standard Technique | These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. |
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| Primary | Sensitivity of EUS-FNA With Capillary Technique | Sensitivity of the EUS-FNA with Capillary technique | The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis. | Posted | | Number | | participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Patients With Positive Gold Standard | gold standard is defined as follows: for resectable cases, surgical histology was considered the gold standard. For unresectable or benign cases, positive cytology (with compatible clinical outcome) at 6-month follow-up was considered gold standard. Negative cytology was confirmed with clinical data and/or imaging at 6 month follow-up. | | OG001 | Patients With Negative Gold Standard | These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. |
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| Primary | Sensitivity of EUS-FNA With StandardTechnique | Sensitivity of the EUS-FNA with Capillary technique | The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis. | Posted | | Number | | Participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Patients With Positive Gold Standard | gold standard is defined as follows: for resectable cases, surgical histology was considered the gold standard. For unresectable or benign cases, positive cytology (with compatible clinical outcome) at 6-month follow-up was considered gold standard. Negative cytology was confirmed with clinical data and/or imaging at 6 month follow-up. | | OG001 | Patients With Negative Gold Standard | These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. |
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| Primary | Sensitivity of EUS-FNA | Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions | The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis. | Posted | | Number | | percentage of positive gold standard | | 6 months | | | | ID | Title | Description |
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| OG000 | Suction Technique | These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. | | OG001 | Capillary Technique | These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously. Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously |
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| Secondary | First Pass Diagnostic Rate | The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass | | Posted | | Number | | participants | | immediate | | | | ID | Title | Description |
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| OG000 | Suction Technique | These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. | | OG001 | Capillary Technique | These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously. Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously |
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| Secondary | Acquisition of Core Tissue | The rate of acquiring core tissue of the pancreatic mass through EUS-FNA | | Posted | | Number | | participants | | immediate | | | | ID | Title | Description |
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| OG000 | Suction Technique | These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. | | OG001 | Capillary Technique | These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously. Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously |
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| Secondary | Diagnostic Accuracy of EUS-FNA | The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease | | Posted | | Number | | percent accurate | | 6 months | | | | ID | Title | Description |
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| OG000 | Suction Technique | These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe. | | OG001 | Capillary Technique | These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously. Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously |
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