Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms

NCT01673334 | Completed Phase 4 DMC

• 1 other identifier: 15779
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to compare the efficacy (diagnostic yield), ease of use, and technical success rates of EUS guided 22 gauge fine needle aspiration to core biopsy in the evaluation of pancreatic tumors. The experimental hypothesis is that FNA will have superior overall diagnostic yield than core biopsy.

Conditions

Pancreatic Tumor

Keywords

Pancreas Tumor EUS FNA Core Biopsy Procore FNB

Outcome Measures

Primary Outcomes (1)

• Diagnostic Yield

  One-week post procedure

Study Arms (1)

Fine Needle Aspiration and Core Biospsy

EXPERIMENTAL

Patients will undergo both FNA and core biopsy during EUS evaluation of a solid pancreatic tumor.

Device: Fine Needle Aspiration (FNA) and Core biopsy (FNB)

Interventions

Fine Needle Aspiration (FNA) and Core biopsy (FNB) DEVICE

Fine Needle Aspiration and Core Biospsy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 and less than 90 years.
• Presence of a solid (greater than 60%) mass lesion within the pancreas on cross-sectional imaging, without a preceding tissue diagnosis.
• Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not correct with the administration of fresh frozen plasma.
• The patient must read and speak english and has signed informed consent document.
• The patient is scheduled for diagnostic endosonography by their referring provider or UVa gastroenterologist.

You may not qualify if:

• Age less than 18 or greater than 90 years.
• The patient is unable to read or understand the consent form.
• The patient is currently pregnant.
• The patient has an uncorrectable coagulopathy as defined by a prolonged prothrombin time (PT) or partial thromboplastin time (PTT) which does not improve with administration of fresh frozen plasma.
• The patient has a pancreatic mass lesion which is predominantly cystic (greater than 40%).
• No mass lesion is identified at the time of endosonography.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Vanessa Shami, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: September 1, 2011
• Primary Completion: July 9, 2013
• Study Completion: July 9, 2013
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

US (1)