Percutaneous Versus EUS FNAC in Pancreatic Masses

NCT ID: NCT04623749

Last Updated: 2021-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2023-03-31

Brief Summary

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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

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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 .

Conditions

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Pancreatic Neoplasm Pancreatic Cyst Pancreatic Abscess

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Percutaneous US guided FNAC in pancreatic masses

Group Type ACTIVE_COMPARATOR

US

Intervention Type PROCEDURE

Percutaneous Ultrasound guided FNAC

EUS guided FNAC in pancreatic masses

Group Type ACTIVE_COMPARATOR

EUS

Intervention Type PROCEDURE

Endoscopic Ultrasound guided FNAC

Interventions

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US

Percutaneous Ultrasound guided FNAC

Intervention Type PROCEDURE

EUS

Endoscopic Ultrasound guided FNAC

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ola Kamal Mohammed Galal

OTHER

Sponsor Role lead

Responsible Party

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Ola Kamal Mohammed Galal

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Ola KM Galal, master

Role: CONTACT

01092502106

References

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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.

Reference Type BACKGROUND
PMID: 25559415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22750974 (View on PubMed)

Related Links

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Other Identifiers

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FNAC in pancreatic masses

Identifier Type: -

Identifier Source: org_study_id

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