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

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ClinicalTrials.gov Identifier: NCT03884179
Recruitment Status : Active, not recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Riadh Sadik, Sahlgrenska University Hospital, Sweden

Brief Summary:
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.

Condition or disease
Pancreatic Cyst Pancreatic Neuroendocrine Carcinoma Pancreatic Pseudocyst Pancreatic Serous Cystadenoma Pancreatic Mucinous Cystadenoma Pancreatic Cystadenocarcinoma Pancreatic Intraductal Papillary-Mucinous Neoplasm Solid Pseudopapillary Tumor of the Pancreas

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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnosis of Pancreatic Cystic Lesions With EUS-FNA and Cross-sectional Imaging - A Report of Accuracy
Actual Study Start Date : February 1, 2007
Actual Primary Completion Date : December 1, 2017
Estimated Study Completion Date : March 1, 2020





Primary Outcome Measures :
  1. Accuracy of EUS-FNA vs Radiology [ Time Frame: 10 years ]
    To compare the accuracy of EUS-FNA(morphology, cytology, CEA(ng/ml)) with CT/MRI in the diagnosis of pancreatic cystic lesions. Surgical pathology is used as gold standard Established CEA cut-offs of >192 ng/ml were used for mucinous assessment and >1000 ng/ml for established cancer assessment. A CEA value of 5 ng/ml or less was indicative of a serous cyst


Secondary Outcome Measures :
  1. Accuracy of EUS-FNA vs morphology [ Time Frame: 10 years ]
    To compare the accuracy of EUS-FNA(morphology, cytology, CEA(ng/ml)) with EUS morphology alone in the diagnosis of pancreatic cystic lesions. Surgical pathology is used as gold standard.Established CEA cut-offs of >192 ng/ml were used for mucinous assessment and >1000 ng/ml for established cancer assessment. A CEA value of 5 ng/ml or less was indicative of a serous cyst

  2. Accuracy of EUS FNA vs cytology [ Time Frame: 10 years ]
    To compare the accuracy of EUS-FNA(morphology, cytology, CEA (ng/ml)) with EUS cytology alone in the diagnosis of pancreatic cystic lesions. Surgical pathology is used as gold standard.Established CEA cut-offs of >192 ng/ml were used for mucinous assessment and >1000 ng/ml for established cancer assessment. A CEA value of 5 ng/ml or less was indicative of a serous cyst

  3. Accuracy of EUS FNA vs CEA [ Time Frame: 10 years ]
    To compare the accuracy of EUS-FNA(morphology, cytology, CEA (ng/ml)) with EUS CEA(ng/ml) alone in the diagnosis of pancreatic cystic lesions. Surgical pathology is used as gold standard.Established CEA cut-offs of >192 ng/ml were used for mucinous assessment and >1000 ng/ml for established cancer assessment. A CEA value of 5 ng/ml or less was indicative of a serous cyst



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All patients with suspected PCLs according to radiology undergoing evaluation with EUS-FNA at a tertiarry endoscopy center from February 2007 until March 2017. The catchemnt area of this cente has a population of about two million.
Criteria

Inclusion Criteria:

Patients with suspected PCLs according to radiology undergoing evaluation with EUS-FNA at a tertiarry endoscopy center from February 2007 until March 2017, who underwent pancreas resection

Oral and written consent of patients examined

Exclusion Criteria:

None

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Responsible Party: Riadh Sadik, Ass Prof, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03884179    
Other Study ID Numbers: SahlgrenskaUHGEA2017
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riadh Sadik, Sahlgrenska University Hospital, Sweden:
Endoscopic ultrasound
Radiology
Accuracy
Pancreatic Cyst
Pancreatic Cystadenocarcinoma
Pancreatic Mucinous Cystadenoma
Pancreatic Intraductal Papillary-Mucinous Neoplasm
Pancreatic Serous Cystadenoma
Pancreatic Pseudocyst
Pancreatic Neuroendocrine Tumor
Solid Pseudopapillary Tumor of the Pancreas
Additional relevant MeSH terms:
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Carcinoma, Neuroendocrine
Cystadenocarcinoma
Pancreatic Cyst
Pancreatic Pseudocyst
Pancreatic Neoplasms
Carcinoma, Islet Cell
Cystadenoma
Pancreatic Intraductal Neoplasms
Cystadenoma, Mucinous
Cystadenoma, Serous
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Cystic, Mucinous, and Serous
Cysts
Pancreatic Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases
Adenoma
Neoplasms, Ductal, Lobular, and Medullary