Recruiting

Observational Study

Sponsor:

AdventHealth

Code:

NCT04085055

Conditions

Pancreatic Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Solid pancreatic mass lesion biopsy

Study Details

Brief summary:

This is a randomized trial to evaluate and directly compare the tissue quality, diagnostic sucess and safety profile of four different Fine Needle Biopsy needles.

Conditions

Pancreatic Neoplasms

Study ID

NCT04085055

Start date

Sep 9, 2019

Status verified date

Aug, 2020

Completion date

Dec, 2020

Anticipated

Primary completion date

Jun 25, 2020

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. All patients referred for EUS-guided tissue acquisition of suspected or confirmed solid pancreatic mass lesions visualized on any radiological imaging
2. Able and willing to provide written or verbal consent
3. ≥ 18 years old
4. Able to undergo conscious sedation for EUS procedure

Exclusion Criteria:

1. <18 years old
2. Unable to obtain informed consent from the patient
3. Medically unfit for sedation
4. Pregnant patients
5. No pancreatic mass lesions visualized on EUS
6. Irreversible coagulopathy as determined by platelet count < 50,000/microL or International Normalized Ratio (INR) > 1.5
7. Unable to stop anti-platelet agents prior to the procedure

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: 22 Gauge FNB Needle - ProCore

The 22 Gauge FNB Needle - ProCore will be used to biopsy solid pancreatic mass lesions.

active comparator: 22 Gauge FNB Needle - Acquire

The 22 Gauge FNB Needle - Acquire will be used to biopsy solid pancreatic mass lesions.

active comparator: 22 Gauge FNB Needle - SharkCore

The 22 Gauge FNB Needle - SharkCore will be used to biopsy solid pancreatic mass lesions.

active comparator: 22 Gauge FNB needle - EZ Shot 3 Plus

The 22 Gauge FNB Needle - EZ Shot 3 Plus will be used to biopsy solid pancreatic mass lesions.

Interventions

Solid pancreatic mass lesion biopsy

The needle will be used to puncture the lesion and remove a piece of tissue from the mass for histological diagnosis.

Primary outcome measure

  • Degree of cellularity in biopsy sample [ Time Frame: 3 days ]

Central Contacts and Locations

Central contacts

Shyam Varadarajulu, MD

407.303.2750shyam.varadarajulu.md@adventhealth.com

Robin Barron-Nelson

321.946.2747robin.barron@flhosp.org

Locations

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

More Information

Sponsor

AdventHealth

Last update posted

Aug 5, 2020

Last verified

Aug, 2020

Keywords

  • pancreatic mass, pancreatic solid mass, pancreatic lesion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth on 2020-08-05.