Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling
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|ClinicalTrials.gov Identifier: NCT02979509|
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment|
|Gastroenterology Lesions||Other: Endoscopic ultrasound- (EUS) guided tissue sampling|
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure commonly used for the investigation of lesions within or adjacent to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different size and types of aspiration and core biopsy needles. More recently, a novel through-the-needle microforceps has been introduced. The MorayTM microforceps fits through a 19-gauge FNA needle and allows targeted tissue sampling under EUS visualization.
Aim - To prospectively evaluate the safety and diagnostic yield of the through-the-needle microforceps for pancreatic and non-pancreatic solid, cystic and mixed solid/cystic lesions.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Multi-center Prospective Evaluation of the Diagnostic Yield of Endoscopic Ultrasound-Guided Tissue Sampling|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||August 2020|
Endoscopic ultrasound- (EUS) guided tissue sampling
All patients scheduled to undergo EUS with tissue sampling (TS) as medically indicated will be considered for the study. Patients in whom EUS-TS is considered as part of their standard medical care will be offered to participate in this study.
Other: Endoscopic ultrasound- (EUS) guided tissue sampling
EUS- guided tissue sampling of solid and/or cystic pancreatic and non-pancreatic lesions as part of their medical care.
Other Name: EUS-TS
- Overall diagnostic yield of EUS-TS [ Time Frame: 2 months ]
- Diagnostic Yield of EUS-guided tissue sampling solid lesions [ Time Frame: 2 months ]
- Diagnostic Yield of EUS-guided tissue sampling cystic lesions [ Time Frame: 2 months ]
- Diagnostic yield of EUS-TS using through-the-needle micro forceps [ Time Frame: 2 months ]
- Diagnostic yield of EUS-TS using fine-needle aspiration [ Time Frame: 2 months ]
- Diagnostic yield of EUS-TS using core biopsy needle [ Time Frame: 2 months ]
- Rate of adverse events associated with EUS-TS [ Time Frame: 48 hours ]Adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)
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): NCT02979509
|Contact: Dennis Yang, MDfirstname.lastname@example.org|
|Contact: Peter V Draganov, MDemail@example.com|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32608|
|Contact: Dennis Yang, MD 352-273-8212 firstname.lastname@example.org|
|Contact: Peter V Draganov, MD 352-273-8212 email@example.com|
|Principal Investigator:||Dennis Yang, MD||University of Florida|