Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling

Completed

• Conditions: Gastroenterology; Lesions
• Interventions: Other: Endoscopic ultrasound- (EUS) guided tissue sampling

• Registration Number: NCT02979509
• Lead Sponsor: University of Florida

Brief Summary

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

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-01
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Age >18 years old
2. Patients referred for EUS-guided tissue sampling for lesions (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions).
3. Target lesion should be ≥ 15 mm in size (long axis).

Read More

Exclusion Criteria

1. Any contraindication to performing endoscopy
2. Unable to provide informed consent

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic ultrasound- (EUS) guided tissue sampling	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.

Primary Outcome Measures

Name	Time	Method
Overall diagnostic yield of EUS-TS	2 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States