On-site Cytopathology EUS-FNA

NCT01386931 | Completed DMC

• 1 other identifier: 11-0919
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Neoplasms; Pancreatic Cancer

Keywords

Biopsy, Fine-Needle; Endoscopic Ultrasonography; cytopathology

Outcome Measures

Primary Outcomes (2)

• Compare the percent of patients with a positive diagnosis of malignancy in each of the two groups.

  The Investigators would like to look at each of the two groups to assess whether or not having an onsite cytopathologist during EUS-FNA increases the diagnostic accuracy of pancreatic malignancies. To do this, the Investigators will compare the percent of patients in each group who were accurately diagnosed with a malignancy during EUS-FNA to see if the on-site cytopathologist group yields a higher percent of positively diagnosed malignancies.

  1 year from the time of patient enrollment

• Compare the percent of patients with inadequate samples (defined by an absence of cellular elements to account for a mass/lesion) between the two groups

  Final slides will be reviewed by three experienced cytopathologists blinded to the patient's randomization group. The slides for each pass will be assessed for: cellularity, adequacy of specimen, contamination, amount of blood, and diagnosis. Using the cytopathologists' assessment of the FNA specimens, the Investigators will compare the percent of patients with inadequate samples in each group to see if the absence of an on-site cytopathologist corresponds with a higher percent of inadequate FNA samples.

  1-2 weeks from patient enrollment/EUS-FNA

Secondary Outcomes (5)

• Compare the sensitivity, specificity and accuracy of EUS-FNA between the two groups

  1 year from patient enrollment

• Compare the mean number of passes in the two groups

  1 year (length of time it takes to enroll all patients)

• Compare the complication rate in the two groups

  1 year (length of time it takes to enroll all patients)

• Compare the EUS procedure duration in each group

  1 year

• Compare the percent of patients requiring repeat procedures between the groups

  1 year after the time of patient enrollment

Study Arms (2)

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.

Procedure: EUS-guided FNA performed with on-site Cytopathologist

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.

Procedure: EUS-guided FNA performed without on-site Cytopathologist

Interventions

EUS-guided FNA performed with on-site Cytopathologist PROCEDURE

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 present during EUS-FNA

EUS-guided FNA performed without on-site Cytopathologist PROCEDURE

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).

Cytopathologist absent during EUS-FNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Potential participants for this study include patients presenting to each of the three tertiary referral centers for an Endoscopic Ultrasound-guided Fine Needle Aspiration.

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Kansas City Veteran Affairs Medical Center: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (28)

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MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Sachin Wani, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: July 1, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 16, 2017
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

US (1)