Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling

Study Overview
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Brief Summary
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All patients will receive standard medical care and no experimental interventions will be performed. 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.

Detailed Description
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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.

Official Title
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Multi-center Prospective Evaluation of the Diagnostic Yield of Endoscopic Ultrasound-Guided Tissue Sampling

Conditions
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Gastroenterology, Lesions

Intervention / Treatment
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* Other: Endoscopic ultrasound- (EUS) guided tissue sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years old Patients referred for EUS-guided tissue sampling for lesions (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). Target lesion should be ≥ 15 mm in size (long axis). Exclusion Criteria: Any contraindication to performing endoscopy Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic ultrasound- (EUS) guided tissue sampling<br>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<br>* EUS- guided tissue sampling of solid and/or cystic pancreatic and non-pancreatic lesions as part of their medical care.<br>* Other names: EUS-TS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall diagnostic yield of EUS-TS |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Yield of EUS-guided tissue sampling solid lesions |  | 2 months | 
| Diagnostic Yield of EUS-guided tissue sampling cystic lesions |  | 2 months | 
| Diagnostic yield of EUS-TS using through-the-needle micro forceps |  | 2 months | 
| Diagnostic yield of EUS-TS using fine-needle aspiration |  | 2 months | 
| Diagnostic yield of EUS-TS using core biopsy needle |  | 2 months | 
| Rate of adverse events associated with EUS-TS | Adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE) | 48 hours |