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
About this trial
This is an interventional diagnostic trial for Pancreatic Neoplasm
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.
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
NCT ID
NCT04623749
First Posted
November 4, 2020
Last Updated
June 11, 2021
Sponsor
Ola Kamal Mohammed Galal
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
Learn more about this trial
Percutaneous Versus EUS FNAC in Pancreatic Masses
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