On-site Cytopathology EUS-FNA

Completed

Conditions studied: Pancreatic Neoplasms, Pancreatic Cancer

In brief

This study is a multicenter prospective randomized controlled trial. Potential participants in this study include patients referred for Endoscopic Ultrasound-guided fine needle aspiration (EUS-FNA) of a solid pancreatic lesion at one of the participating centers. If the patient meets inclusion criteria and signs the informed consent, they will be randomized into one of the two study arms in a 1:1 ratio. Patients will either undergo EUS-FNA with or without an on-site cytopathologist present during EUS-FNA. Patients assigned to the on-site cytopathologist arm will have the cytopathologist dictate the number of fine needle aspiration (FNA) passes performed by the endosonographer. This number will be based on the adequacy of specimen and the ability to provide a preliminary diagnosis. In the other arm, 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). The technique of performing EUS-FNA (needle type, use of stylet, suction) will be standardized among all endosonographers in order to rule out confounding factors. 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. 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.

Key facts

Study ID

NCT01386931

Run by

University of Colorado, Denver

People needed

111

Starts

2011-06-01

Expected to finish

2017-06-16

Last updated by the study team

2018-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients age: greater than or equal to 18 years
• 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

You may not qualify if…

• Severe coagulopathy [International Normalized Ratio (INR) > 1.8] or thrombocytopenia (platelet count <50,000)
• 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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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