Pancreatic Neoplasms(FACET)NCT04165018
Prospective Study FNB, Is It Time To Abandon Cytological Assessment
An observational study of Pancreatic Neoplasms, run by Baylor College of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Fine-Needle Biopsy (FNB)
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Apr 2021to 10 Oct 2023
- How long will I take part?
- 48 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to EUS-FNB for pancreatic mass lesions
Who may be able to join
- Patient is greater than or equal to 18 years of age
- Patient is referred to EUS-FNB for pancreatic mass lesions
Who cannot join
- Patient is younger than 18 years of age
- Patient refused and/or unable to provide consent
- Patient is a pregnant woman
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
Baylor St. Lukes Medical Center (BSLMC)
Houston, Texas, 77030
About this study
Official title: Prospective Study FNB, Is It Time To Abandon Cytological Assessment (FACET)
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
- Being tested
- Fine-Needle Biopsy (FNB)
- Keywords
- Pancreatic masses and lesions
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine-Needle Biopsy (FNB)Procedure or surgery
Fine-needle biopsy may be used to take samples of a pancreatic neoplasm.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Diagnostic yield between FNB samples placed in formalin for pathology evaluation from two different types of needle
Measured: 2 years
Secondary outcomes (1)
Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start9 Apr 2021
- Primary completion6 Apr 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 48 Weeks
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Othman, MD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165018
- Sponsor's protocol ID
- H-44963
- Acronym
- (FACET)
- Status last verified
- Oct 2023
- First submitted
- 1 Nov 2019
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ayoub F, Khan V, Jain S, Raza R, Tan M, Zabad N, Keihanian T, Sparkman J, Jawaid S, Sealock RJ, Abidi W, Patel K, Othman MO. Diagnostic yield of endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions with tissue sent directly in formalin for histopathologic evaluation compared with cytology: a multicenter prospective pilot study. Gastrointest Endosc. 2026 Jul;104(1):107-110. doi: 10.1016/j.gie.2025.12.267. Epub 2025 Dec 16.
PubMed 41412424
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study FNB, Is It Time To Abandon Cytological Assessment (FACET)
- ClinicalTrials.gov ID
- NCT04165018
- Acronym / sponsor ID
- (FACET) / H-44963
- Conditions
- Pancreatic Neoplasms
- Keywords
- Pancreatic masses and lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Weeks
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to EUS-FNB for pancreatic mass lesions
Key inclusion criteria (2 listed)
- Patient is greater than or equal to 18 years of age
- Patient is referred to EUS-FNB for pancreatic mass lesions
Key exclusion criteria (3 listed)
- Patient is younger than 18 years of age
- Patient refused and/or unable to provide consent
- Patient is a pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fine-Needle Biopsy (FNB)Fine-needle biopsy may be used to take samples of a pancreatic neoplasm. | Procedure or surgery | – |
Primary outcome
Sensitivity and Specificity using FNB sampling pancreatic mass
Time frame: 2 years
% of core tissue obtained, number of needle passes made, and assessment of any procedure related adverse events
Diagnostic yield between FNB samples placed in formalin for pathology evaluation from two different types of needle
Time frame: 2 years
1 secondary outcome
Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Derived from this study: PubMed 41412424Ayoub F, Khan V, Jain S, Raza R, Tan M, Zabad N, Keihanian T, Sparkman J, Jawaid S, Sealock RJ, Abidi W, Patel K, Othman MO. Diagnostic yield of endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions with tissue sent directly in formalin for histopathologic evaluation compared with cytology: a multicenter prospective pilot study. Gastrointest Endosc. 2026 Jul;104(1):107-110. doi: 10.1016/j.gie.2025.12.267. Epub 2025 Dec 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms, run by Baylor College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity using FNB sampling pancreatic mass (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04165018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.