Study Results
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Basic Information
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COMPLETED
111 participants
OBSERVATIONAL
2011-06-30
2017-06-16
Brief Summary
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Future clinical intervention will be monitored for the purpose of reporting the impact EUS-FNA has on the patient's clinical course and determining diagnostic accuracy. Patients will be followed prospectively for at least one year, and the gold-standard for final diagnosis of pancreatic malignancy will be defined by the presence of malignant cytology or histologic evidence (if the patient undergoes surgery) or with clinical and/or imaging follow-up consistent with pancreatic cancer (death or clinical progression). A detailed account of medical equipment used during each procedure, procedure time, clinic visits/hospitalizations due to procedure related complications, and number of repeat procedures will be recorded systematically.
The investigators hypothesize that an on-site cytopathologist during EUS-FNA for pancreatic masses improves diagnostic yield, accuracy, and lowers the duration, complications and the need for repeat procedures.
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Detailed Description
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In this proposed randomized controlled multicenter trial, the investigators hypothesize that an on-site cytopathologist during EUS-FNA for pancreatic masses improves diagnostic yield, accuracy, and lowers the duration, complications and the need for repeat procedures. This hypothesis will be explored in the context of the following specific aims.
Specific aim #1: To compare the diagnostic yield of malignancy and proportion of inadequate specimens between the two groups.
Specific aim #2: To compare the sensitivity, specificity and accuracy of EUS-FNA between the two groups using histologic diagnosis or cytologic diagnosis in conjunction with clinical and/or imaging follow-up as the gold standard.
Specific aim #3: To compare the duration, rate of complications and repeat procedures between the two groups.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cytopathologist present during EUS-FNA
Patients assigned to the on-site cytopathologist arm will have the cytopathologist dictate the number of FNA passes performed by the endosonographer. This number will be based on the adequacy of specimen and the ability to provide a preliminary diagnosis.
After EUS-FNA is performed all slides will be sent to the pathology department. The slides will be sent for review regardless of which arm the patient is randomized into, and they will be reviewed by experienced cytopathologists for the purpose of determining the final diagnoses.
EUS-guided FNA performed with on-site Cytopathologist
Patients assigned to the on-site cytopathologist arm will have the cytopathologist dictate the number of FNA passes performed by the endosonographer. This number will be based on the adequacy of specimen and the ability to provide a preliminary diagnosis.
Cytopathologist absent during EUS-FNA
In the absence of an on-site cytopathologist, the endosonographer will perform a predetermined number of 7 passes (standard of care in the absence of an on-site cytopathologist).
After EUS-FNA is performed all slides will be sent to the pathology department. The slides will be sent for review regardless of which arm the patient is randomized into, and they will be reviewed by experienced cytopathologists for the purpose of determining the final diagnoses.
EUS-guided FNA performed without on-site Cytopathologist
In the absence of an on-site cytopathologist, the endosonographer will perform a predetermined number of 7 passes (standard of care in the absence of an on-site cytopathologist).
Interventions
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EUS-guided FNA performed with on-site Cytopathologist
Patients assigned to the on-site cytopathologist arm will have the cytopathologist dictate the number of FNA passes performed by the endosonographer. This number will be based on the adequacy of specimen and the ability to provide a preliminary diagnosis.
EUS-guided FNA performed without on-site Cytopathologist
In the absence of an on-site cytopathologist, the endosonographer will perform a predetermined number of 7 passes (standard of care in the absence of an on-site cytopathologist).
Eligibility Criteria
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Inclusion Criteria
* Presence of a solid pancreatic mass lesion confirmed by at least a single investigational modality such as computerized axial tomography (CT) scan, magnetic resonance imaging (MRI) or Endoscopic Ultrasound (EUS)
* Ability to provide written informed consent
Exclusion Criteria
* Pure cystic lesions of the pancreas
* Inability to sample lesion due to the presence of intervening blood vessels
* Results of EUS-FNA would not impact patient management
18 Years
ALL
No
Sponsors
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Kansas City Veteran Affairs Medical Center
FED
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Sachin Wani, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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Rastogi A, Wani S, Gupta N, Singh V, Gaddam S, Reddymasu S, Ulusarac O, Fan F, Romanas M, Dennis KL, Sharma P, Bansal A, Oropeza-Vail M, Olyaee M. A prospective, single-blind, randomized, controlled trial of EUS-guided FNA with and without a stylet. Gastrointest Endosc. 2011 Jul;74(1):58-64. doi: 10.1016/j.gie.2011.02.015. Epub 2011 Apr 23.
Mohamadnejad M, Mullady D, Early DS, Collins B, Marshall C, Sams S, Yen R, Rizeq M, Romanas M, Nawaz S, Ulusarac O, Hollander T, Wilson RH, Simon VC, Kushnir V, Amateau SK, Brauer BC, Gaddam S, Azar RR, Komanduri S, Shah R, Das A, Edmundowicz S, Muthusamy VR, Rastogi A, Wani S. Increasing Number of Passes Beyond 4 Does Not Increase Sensitivity of Detection of Pancreatic Malignancy by Endoscopic Ultrasound-Guided Fine-Needle Aspiration. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1071-1078.e2. doi: 10.1016/j.cgh.2016.12.018. Epub 2016 Dec 23.
Other Identifiers
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11-0919
Identifier Type: OTHER
Identifier Source: secondary_id
11-0919
Identifier Type: -
Identifier Source: org_study_id
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