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Percutaneous Versus EUS FNAC in Pancreatic Masses

Primary Purpose

Pancreatic Neoplasm, Pancreatic Cyst, Pancreatic Abscess

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
US
EUS
Sponsored by
Ola Kamal Mohammed Galal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Neoplasm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 50 Patients in different sex & age groups with pancreatic masses

Exclusion Criteria:

  • Any general contraindications for FNAC or EUS in some cases as Coagulopathy with INR >1.5 or platelet count <50,000/mmc, Antithrombotic therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Percutaneous US guided FNAC in pancreatic masses

    EUS guided FNAC in pancreatic masses

    Arm Description

    Outcomes

    Primary Outcome Measures

    Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by Trans abdominal US-FNAC. diagnostic accuracy
    Percutaneous US guided FNAC technique

    Secondary Outcome Measures

    Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNAC. diagnostic accuracy
    EUS guided FNAC technique

    Full Information

    First Posted
    November 4, 2020
    Last Updated
    June 11, 2021
    Sponsor
    Ola Kamal Mohammed Galal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04623749
    Brief Title
    Percutaneous Versus EUS FNAC in Pancreatic Masses
    Official Title
    Percutaneous Versus Endoscopic Guided Fine Needle Aspiration Cytology in Diagnosis of Pancreatic Masses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ola Kamal Mohammed Galal

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    We aim to evaluate the role of Ultrasound-guided (USG) fine needle aspiration cytology (FNAC) in diagnosis of pancreatic masses compared to endoscopic ultrasound (EUS) guided fine needle aspiration cytology (FNAC).
    Detailed Description
    Pancreatic cancer is the fourth leading cause of cancer-related mortality in the United States. Over 45,000 patients are diagnosed each year in the United States, and the majority of these patients succumb to their disease. Eighty percentages of patients are diagnosed with advanced, unrespectable disease. According to the latest statistics, only 7 % of patients survive 5 years after diagnosis. While the 5-year survival rate improves to 25 % in patients presenting with stage 1or localized disease, only 9 % of patients are identified at this early stage. The majority of patients (53%) presents with distant metastatic disease, and have a 5-year survival of 2%. Improving the prognosis of patients with pancreatic cancer is a challenge. Overall, pancreatic cancer has one of the worst prognoses among all cancers; however, the prognosis is better if cancer is detected at an early stage. For example, patients with pancreatic cancers ≤1 cm in size at the time of diagnosis have a 5-year survival rate of 80.4% . Because such small cancers now account for 0.8% of all pancreatic cancer, detection of more small cancers would contribute to improving mortality rates. The diagnostic approach to a possible pancreatic mass lesion relies first upon various non-invasive imaging modalities, including computed tomography, ultrasound, and magnetic resonance imaging techniques. Once a suspect lesion has been identified, tissue acquisition for characterization of the lesion is often paramount in developing an individualized therapeutic approach. Tools , in addition to radiologic imaging , currently employed in the initial evaluation of a patient with a pancreatic mass lesion include serum tumor markers , endoscopic retrograde cholangiopancreatography, Ultrasound-guided (USG) fine needle aspiration cytology (FNAC) and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) . Advancements in radiologic and endoscopic ultrasound (EUS) imaging have improved our ability to detect and stage pancreatic masses allowing for more selective surgical intervention for patients with resectable disease. Owing to the low sensitivity of cross-sectional imaging to detect small tumors in the pancreas. Endoscopic ultrasound (EUS), in which the tip of the endoscope contains a high-frequency transducer , provides high resolution images of the pancreas. Indeed , its high resolution in experienced hands enables detection of focal lesions as small as 2-5 mm . Ultrasound-guided (USG) fine needle aspiration cytology (FNAC) has emerged as a primary diagnostic modality in investigation in patients with pancreatic lesions. This technique was introduced into clinical practice nearly 3 decades ago and has proved to be a simple, cost-effective and minimally invasive technique that can yield material for tissue diagnosis .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Neoplasm, Pancreatic Cyst, Pancreatic Abscess

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Percutaneous US guided FNAC in pancreatic masses
    Arm Type
    Active Comparator
    Arm Title
    EUS guided FNAC in pancreatic masses
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    US
    Intervention Description
    Percutaneous Ultrasound guided FNAC
    Intervention Type
    Procedure
    Intervention Name(s)
    EUS
    Intervention Description
    Endoscopic Ultrasound guided FNAC
    Primary Outcome Measure Information:
    Title
    Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by Trans abdominal US-FNAC. diagnostic accuracy
    Description
    Percutaneous US guided FNAC technique
    Time Frame
    intraopeatve
    Secondary Outcome Measure Information:
    Title
    Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNAC. diagnostic accuracy
    Description
    EUS guided FNAC technique
    Time Frame
    intraoperative

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 50 Patients in different sex & age groups with pancreatic masses Exclusion Criteria: Any general contraindications for FNAC or EUS in some cases as Coagulopathy with INR >1.5 or platelet count <50,000/mmc, Antithrombotic therapy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ola KM Galal, master
    Phone
    01092502106
    Email
    olakmgalal@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25559415
    Citation
    Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.
    Results Reference
    background
    PubMed Identifier
    22750974
    Citation
    Egawa S, Toma H, Ohigashi H, Okusaka T, Nakao A, Hatori T, Maguchi H, Yanagisawa A, Tanaka M. Japan Pancreatic Cancer Registry; 30th year anniversary: Japan Pancreas Society. Pancreas. 2012 Oct;41(7):985-92. doi: 10.1097/MPA.0b013e318258055c.
    Results Reference
    background
    Links:
    URL
    http://ganjoho.jp/en/professional/statistics/brochure/2017_en.html
    Description
    Related Info
    URL
    http://seer.cancer.gov/csr/1975_2015/
    Description
    Related Info

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    Percutaneous Versus EUS FNAC in Pancreatic Masses

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