Prospective Study FNB, Is It Time To Abandon Cytological Assessment

NCT ID: NCT04165018

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-09
• Study Completion Date: 2023-10-10

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Fine-Needle Biopsy (FNB)

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Othman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baylor College of Medicine

Houston, Texas, United States

Baylor St. Lukes Medical Center (BSLMC)

Houston, Texas, United States

Countries

United States

Other Identifiers

H-44963

Identifier Type: -

Identifier Source: org_study_id