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Pancreatic Cyst clinical trials

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NCT ID: NCT04140435 Recruiting - Pancreatic Cyst Clinical Trials

EUS-guided Through-the-needle Microforceps Biopsy Outcomes

Start date: October 22, 2019
Phase:
Study type: Observational

INTRODUCTION: The diagnosis of pancreatic cystic lesions (PCLs) is increasing due to improvements of cross-sectional imaging. It is mandatory, for appropriate management, to make an accurate diagnosis and risk stratification, since some of these lesions may harbor malignancy or have potential for malignant transformation and hence surgical resection is required. Diagnostic evaluation of PCLs can be challenging, requiring a combination of different methods. Usually PCLs are been initially detected by cross-sectional imaging. However, imaging alone has not been shown to reliably identify the underlying pathology in PCLs with a high degree of accuracy. Hence, Endoscopic ultrasound with fine-needle aspiration (EUS-FNA) is routinely performed. EUS-FNA plays an important role in cyst characterization since allows morphological examination (EUS-B mode), aspiration for cytology and cyst fluid analysis for carcinoembryonic antigen (CEA), amylase and glucose levels; and allows to tissue sample in case of mural nodules o wall thickness. Even though EUS-FNA has been shown to be the test of choice for select lesions with high-risk features, has its limitations related to low sensitivity and specificity. The morphological characterization by EUS of PCL, as well as with the cross-sectional images, depends most of the time, on the subjective interpretation of the operator, which can be very difficult sometimes and depend on experience. A cyst fluid CEA cutoff of 192 ng/mL has been commonly accepted for differentiating mucinous from non-mucinous cysts. However, has the limitation of requiring at least 0.5 mL of cyst fluid for CEA analysis, has a relatively low sensitivity (75%) and specificity (84%), cannot differentiate cyst histotypes, and controversial results have been reported. Finally targeted cyst wall with the tip of the FNA needle can increase the diagnostic accuracy, yet the cytological yield with EUS-FNA remains low due to the relatively small tissue sample. Hence, diagnostic accuracy of currently available tools for evaluation of PCLs including cross-sectional imaging, EUS morphologic features, EUS-FNA for cyst fluid analysis and cytology is not perfect, leading to possible misdiagnosis.

NCT ID: NCT04064034 Completed - Pancreas Cancer Clinical Trials

ALateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Researchers have developed a new test to measure a protein QSOX1 that is found to be elevated in subjects with pancreas cancer. Researchers are looking to use this test to compare subjects with pancreas cancer and subjects without pancreas cancer to see if this test could be used to diagnosis pancreas cancer.

NCT ID: NCT03884179 Active, not recruiting - Pancreatic Cyst Clinical Trials

Diagnosis of PCL With EUS-FNA and Cross-sectional Imaging - A Report of Accuracy

Start date: February 1, 2007
Phase:
Study type: Observational

Pancreatic cystic lesions (PCLs) comprise of a heterogeneous group of entities that are benign, premalignant or malignant. With increased use of modern imaging techniques in recent years, incidentally discovered PCL have become much more common. However, imaging modalities for characterising PCL is a known clinical uncertainty since imaging is capable of detecting these lesions but may often not be able to distinguish malignant from benign lesions. Incorrect assessment of PCL can lead to fatal consequences because a malignant lesion may not be treated and a benign may be unnecessarily resected. The aim of this study was to assess the performance of endoscopic ultrasound with fine-needle aspiration (EUS-FNA) in the diagnosis of pancreatic cystic lesions compared to cross-sectional imaging modalities (CT/MRI). Our hypothesis is that EUS-FNA has a higher accuracy for diagnosing PCLs compared with cross-sectional imaging.

NCT ID: NCT03855800 Recruiting - Pancreas Cyst Clinical Trials

Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

Start date: May 11, 2018
Phase: N/A
Study type: Interventional

Researchers are trying to find out whether new tests ("biomarkers") of blood, stool, pancreas cyst fluid, or pancreas juice can be used to diagnose malignant or pre-malignant changes in pancreas cysts.

NCT ID: NCT03820531 Completed - Pancreas Cyst Clinical Trials

DNA-mutation Analysis in Cyst Fluid of Suspected Intraductal Papillary Mucinous Neoplasia of the Pancreas

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Diagnostic tools are needed to identify mucinous cysts for further evaluation or follow-up respectively to identify cysts with HGD or invasive cancer at an early stage for surgical resection. Molecular genetic analysis of pancreatic cyst fluid is a new but rapidly evolving method to identify KRAS/GNAS oncogenic driver mutations in mucinous cysts and to identify tumour suppressor gene mutations which are involved in advanced cysts with HGD or carcinoma. The ongoing ZYSTEUS-study tries to implement DNA mutation analysis by Next Generation Sequencing in the diagnostic algorithm of pancreas cyst evaluation. The first aim is to distinguish mucinous from non-mucinous cysts. The second aim is to define relevant tumour suppressor gene mutations which are relevant to distinguish between LGD and HGD/carcinoma in mucinous cysts.

NCT ID: NCT03740360 Completed - Pancreatic Cyst Clinical Trials

Contrast Enhanced Ultrasound and Molecular Analysis in the Diagnosis of Pancreatic Cyst

Start date: June 1, 2017
Phase:
Study type: Observational [Patient Registry]

This study evaluates the use of contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) and cyst fluid molecular analysis in the differential diagnosis of pancreatic cysts and the detection of malignancy.

NCT ID: NCT03731819 Completed - Pancreas Cyst Clinical Trials

Establishment of Abbreviated Pancreatobiliary MRI Protocol

Start date: November 5, 2018
Phase: N/A
Study type: Interventional

This study aims to establish abbreviated PB MRI protocol for patients on regular imaging follow-up for pancreas cystic neoplasm.

NCT ID: NCT03578445 Completed - Clinical trials for Pancreatic Adenocarcinoma

Utility of EUS-guided Microbiopsies in Pancreatic Cystic Lesions

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to determine clinical impact of EUS-guided microbiopsy procedure and supplementary molecular analyses compared to standard diagnostic workup of pancreatic cysts. The hypothesis is that a combination of previously mentioned modalities may change the management of some pancreatic cystic lesions, increase the diagnostic accuracy and optimize the discrimination between high- and low-risk pancreatic cysts.

NCT ID: NCT03568630 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Blood Markers of Early Pancreas Cancer

Start date: July 26, 2018
Phase:
Study type: Observational

Identifying biomarkers of early pancreatic ductal adenocarcinoma (PDAC) could facilitate screening for individuals at higher than average risk and expedite the diagnosis in individuals with symptoms and substantially improve an individual's chance of surviving the disease. The investigators propose a longitudinal study of subjects at higher than average risk of PDAC in order to generate clinical data and bank serial blood specimens.

NCT ID: NCT03536793 Recruiting - Cancer of Pancreas Clinical Trials

Tumour Regulatory Molecules in Early Pancreatic Cancer Detection

TEM-PAC
Start date: October 24, 2018
Phase:
Study type: Observational

The effective diagnosis of pancreatic cancer is often quite challenging, due to a lack of disease-specific symptoms, resulting in the majority of patients presenting with advanced disease, with an associated dismal prognosis. Earlier detection of pancreatic cancer, at a stage where surgery is feasible, would greatly increase the 5-year survival rate. Detecting pancreatic cancer early is therefore vital to improve the prognosis for these patients. Pre-cancerous pancreatic cysts are an early indicator of malignant transformation. The ideal screening test would be capable of detecting pancreatic cancer at these initial stages. Current procedures for pancreatic cancer diagnosis are invasive, uncomfortable and costly, and can be considered unnecessary in those cysts found to be benign. We propose to study a number of tumour regulatory molecules that have been the subject of research in laboratories at the University of Hull (e.g., tissue factor (TF), adrenomedullin (AM) using enzyme-linked immunosorbent assays (ELISA) tests) that have been studied in the context of carcinogenic transformation in more common malignancies but have yet to be fully tested in pancreatic malignant transformation. The recent introduction of platform technologies at the University of Hull has broadened this area of investigation by giving us access to next generation genomic sequencing and proteomic analyses of small amounts of tissue samples. We intend to analyse pancreatic cystic fluid samples using these technologies to discover new regulatory molecules. Altogether, his study will measure the levels of novel regulatory molecules and genetic changes involved with pancreatic cancer carcinogenesis using a combination of conventional techniques (e.g. ELISA) and state-of-the-art platform technologies in pancreatic cysts from those patients in whom cancer may be suspected, to determine the potential of these molecules to serve as markers to detect early changes towards pancreatic cancer.