Simple Technique to Improve Diagnostic Yield in EUS-FNA
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ClinicalTrials.gov Identifier: NCT01995474 |
Recruitment Status :
Completed
First Posted : November 26, 2013
Last Update Posted : November 26, 2013
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Condition or disease | Intervention/treatment | Phase |
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Lesion Sampled for Cytology | Other: Twisted Syringe Other: Conventional Technique | Not Applicable |
Endoscopic ultrasound (EUS) has evolved into a minimally invasive diagnostic and staging method. The addition of fine needle aspiration (FNA) increases the accuracy of EUS in the diagnosis and staging of pancreatic malignancies. An ultrasound probe attached to the end of the endoscope allows real-time direct visualization by means of ultrasound transmission. During the FNA process a needle is advanced through the biopsy channel of the endoscope and into the target lesion. In order to obtain a tissue specimen of a suspicious pancreatic lesion, an FNA needle must traverse either the stomach or duodenum to access the pancreatic mass. Once the needle has entered the target lesion a syringe is exchanged for the needle stylet and negative pressure is applied allowing acquisition of a cytology specimen. Negative pressure is released from the syringe and the stop cock is closed to the syringe. However, due to the relatively long length of the needle there is is significant remaining negative pressure at the needle tip. This leads to aspiration of surrounding material including GI mucosal contamination into the needle while removing it from the target lesion.
Contamination of the FNA specimen from gastric or duodenal epithelium can occur with continued negative pressure at the needle tip upon withdrawal of the needle out of the target lesion. While EUS-FNA has a high specificity (96%), sensitivity (87%), and accuracy (94%), gastrointestinal tract contamination can lead to misinterpretation of FNA specimens. Based on clinical experience, we propose a technique to eliminate any remaining negative pressure during EUS-FNA and therefore decreasing gastrointestinal tract contamination.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Diagnostic |
Official Title: | Eliminating the Residual Negative Pressure in the EUS-FNA Needle Before Withdrawal Enhances the FNA Cytology Yield |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | October 2012 |
Arm | Intervention/treatment |
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Experimental: Twisted Syringe
briefly disconnecting the syringe from the biopsy channel after a specimen is obtained and then reconnecting it
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Other: Twisted Syringe
briefly disconnecting the syringe from the biopsy channel after a specimen is obtained and then reconnecting it |
Active Comparator: Conventional Technique
syringe is exchanged for the needle stylet and negative pressure is applied allowing acquisition of a cytology specimen.
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Other: Conventional Technique
syringe is exchanged for the needle stylet and negative pressure is applied allowing acquisition of a cytology specimen. |
- Efficacy of FNA biopsy [ Time Frame: 1 week ]The efficacy of fine needle aspiration is assessed using on site cytopathologists who are blinded with respect to the study ARM. The efficacy of diagnostic yield from samples obtained using the needle-off technique is directly compared to the diagnostic yield of samples obtained using conventional technique.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18
- Not pregnant
- Can give consent
- Patients with suspicious GI lesions in need of tissue diagnosis by means of EUS/FNA
Exclusion Criteria:
- Pregnant
- Age < 18
- Cannot give consent
- EUS not technically possible

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995474
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Principal Investigator: | Kulwinder Dua, MD | Medical College of Wisconsin |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Medical College of Wisconsin |
ClinicalTrials.gov Identifier: | NCT01995474 |
Other Study ID Numbers: |
PRO-00012314 |
First Posted: | November 26, 2013 Key Record Dates |
Last Update Posted: | November 26, 2013 |
Last Verified: | November 2013 |
EUS pancreatic cancer cytology fine needle aspiration |