Prospective Study FNB, Is It Time To Abandon Cytological Assessment

NCT04165018 | Completed

• 1 other identifier: H-44963
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

Endoscopic Ultrasound (EUS) is a minimally invasive procedure used by gastroenterologists to examine pancreatic masses and lesions. A fine needle is traversed through an endoscope and used to acquire tissue samples, which are then sent for pathology. The standard approach for diagnosing solid pancreatic lesions has been fine needle aspiration (FNA) (Han et al. 2016). However, the use of FNA comes with its limitations, some of which include multiple needle passes to acquire fluid, the need for on-site cytologists, and decreased diagnostic yield. Fine needle biopsy (FNB) is the latest approach being employed by endosonographers in lieu of FNA. FNB confers several advantages over FNB. First, FNB requires fewer needle passes than FNA to acquire tissue sample for immunohistochemical staining. In addition, FNB provides better tissues samples, greater sensitivity of the tissue core, and thus, improved diagnostic yields (Tian et al. 2018). Finally, FNB is more cost-effective than FNA and relies on pathologists, instead of on-site cytologists, and preserves the tissue core (Tian et al. 2018). The objective of this study is to establish a database of samples placed in formalin for patients who will undergo a fine-needle biopsy (FNB) for pathological evaluation without rapid on site cytological assessment.

Conditions

Pancreatic Neoplasms

Keywords

Pancreatic masses and lesions

Outcome Measures

Primary Outcomes (2)

• Sensitivity and Specificity using FNB sampling pancreatic mass

  % of core tissue obtained, number of needle passes made, and assessment of any procedure related adverse events

  2 years

• Diagnostic yield between FNB samples placed in formalin for pathology evaluation from two different types of needle

  2 years

Secondary Outcomes (1)

• Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation

  2 years

Interventions

Fine-Needle Biopsy (FNB) PROCEDURE

Fine-needle biopsy may be used to take samples of a pancreatic neoplasm.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to EUS-FNB for pancreatic mass lesions

You may qualify if:

• Patient is greater than or equal to 18 years of age
• Patient is referred to EUS-FNB for pancreatic mass lesions

You may not qualify if:

• Patient is younger than 18 years of age
• Patient refused and/or unable to provide consent
• Patient is a pregnant woman

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Baylor St. Lukes Medical Center (BSLMC)

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pancreatic mass biopsy for pathological evaluation

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 15, 2019
• Study Start: April 9, 2021
• Primary Completion: April 6, 2023
• Study Completion: October 10, 2023
• Last Updated: March 24, 2026

Record last verified: 2023-10

Locations

US (2)