On-site Cytopathology EUS-FNA
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/23/2018 |
| Start Date: | June 2011 |
| End Date: | June 16, 2017 |
The Clinical Impact of Immediate On-site Cytopathology Evaluation During Endoscopic Ultrasound-Guided Fine Needle Aspiration of Pancreatic Mass: A Multicenter, Prospective Randomized Controlled Trial
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.
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.
Endoscopic Ultrasound (EUS) plays an integral role in the diagnosis of suspected pancreatic
cancer, and the EUS findings are crucial for determining the course of future management and
potential treatment options for these patients. EUS is the most sensitive imaging modality
for the detection of pancreatic masses, and has a sensitivity of greater than or equal to
90%. Furthermore, EUS-guided fine needle aspiration (EUS-FNA) plays an important role in
accurate staging of pancreatic cancer with a sensitivity of 85% and specificity close to
100%. EUS-FNA is considered to be cost-effective by virtue of its impact on therapeutic
management. In particular, real-time tissue sampling by EUS-FNA is possible when a
cytopathologist (pathologist skilled in evaluating fine needle aspiration specimens) is able
to be present at the time of FNA in order to review the biopsy slides and make a preliminary
diagnosis. The availability of an on-site cytopathologist has the potential to provide quick
diagnostic and predictive information to confirm the presence and staging of suspected
malignancy. The rationale for an on-site cytopathologist includes increasing the adequacy and
yield of biopsy tissue/aspirate which can decrease the need for additional passes to obtain a
diagnostic yield of tissue. This hypothesis, however, has not been formally examined.
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.
cancer, and the EUS findings are crucial for determining the course of future management and
potential treatment options for these patients. EUS is the most sensitive imaging modality
for the detection of pancreatic masses, and has a sensitivity of greater than or equal to
90%. Furthermore, EUS-guided fine needle aspiration (EUS-FNA) plays an important role in
accurate staging of pancreatic cancer with a sensitivity of 85% and specificity close to
100%. EUS-FNA is considered to be cost-effective by virtue of its impact on therapeutic
management. In particular, real-time tissue sampling by EUS-FNA is possible when a
cytopathologist (pathologist skilled in evaluating fine needle aspiration specimens) is able
to be present at the time of FNA in order to review the biopsy slides and make a preliminary
diagnosis. The availability of an on-site cytopathologist has the potential to provide quick
diagnostic and predictive information to confirm the presence and staging of suspected
malignancy. The rationale for an on-site cytopathologist includes increasing the adequacy and
yield of biopsy tissue/aspirate which can decrease the need for additional passes to obtain a
diagnostic yield of tissue. This hypothesis, however, has not been formally examined.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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