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临床试验/NCT04623749
NCT04623749Unknown不适用

Percutaneous Versus Endoscopic Guided Fine Needle Aspiration Cytology in Diagnosis of Pancreatic Masses

Ola Kamal Mohammed Galal0 个研究点目标入组 50 人开始时间: 2021年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by Trans abdominal US-FNAC. diagnostic accuracy

研究概览

简要总结

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).

详细描述

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 .

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: intraopeatve

Percutaneous US guided FNAC technique

次要结局

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

研究者

发起方
Ola Kamal Mohammed Galal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ola Kamal Mohammed Galal

Principal Investigator

Assiut University

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