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Percutaneous Versus EUS FNAC in Pancreatic Masses

O

Ola Kamal Mohammed Galal

Status

Unknown

Conditions

Pancreatic Cyst
Pancreatic Abscess
Pancreatic Neoplasm

Treatments

Procedure: EUS
Procedure: US

Study type

Interventional

Funder types

Other

Identifiers

NCT04623749
FNAC in pancreatic masses

Details and patient eligibility

About

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).

Full 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 .

Enrollment

50 estimated patients

Sex

All

Volunteers

Accepts 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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Percutaneous US guided FNAC in pancreatic masses
Active Comparator group
Treatment:
Procedure: US
EUS guided FNAC in pancreatic masses
Active Comparator group
Treatment:
Procedure: EUS

Trial contacts and locations

0

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Central trial contact

Ola KM Galal, master

Data sourced from clinicaltrials.gov

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