Adenocarcinoma of the Pancreas, Pancreatic Cancer, Pancreatic Neoplasms
Conditions
Brief summary
This is a randomized trial to evaluate the optimal number of passes required during endoscopic ultrasound-guided fine needle biopsy for molecular profiling in pancreatic cancer
Detailed description
Endoscopic ultrasound-guided fine needle tissue acquisition is currently the gold standard for sampling solid pancreatic masses. By using novel fine needle biopsy (FNB) needles during EUS-guided tissue sampling, core tissue samples can also now be obtained, with diagnostic adequacy of \>90%. Molecular profiling is becoming increasingly important in the management of pancreatic adenocarcinoma for targeted therapy. As the procurement of core tissue is possible with EUS-FNB, adequate tissue can now be obtained for molecular profiling. However, the number of passes required during EUS-FNB to obtain sufficient quantity of core tissue to successfully perform molecular profiling is unknown, although usually 2-3 passes are performed as standard of care practice. The primary aim of this study is therefore to elucidate the optimal number of passes required during EUS-FNB to procure adequate tissue for molecular profiling in patients with pancreatic adenocarcinoma.
Interventions
PROCEDURE2 passes during EUS-guided fine needle biopsy
Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of two passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.
PROCEDURE3 passes during EUS-guided fine needle biopsy
Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of three passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.
Sponsors
Orlando Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The patient undergoing the procedure, research coordinator calling patients for follow-up and the pathologist performing molecular profiling will be blinded to the randomization group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years and over 2. Suspected or confirmed pancreatic mass seen on imaging, requiring endoscopic ultrasound-guided fine needle biopsy
Exclusion criteria
1. Age \< 18 years 2. Females who are pregnant 3. Pancreatic mass is not accessible for fine needle biopsy via endoscopic ultrasound 4. Biopsied pancreatic mass is not adenocarcinoma on pathology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy | 7 days | Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy of pancreatic adenocarcinoma, with comparison between two and three passes during fine needle biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of actionable mutations detected on molecular profiling | 7 days | Number of actionable mutations detected on molecular profiling |
| Rate of technical success | 1 day | Rate of technical success of EUS-guided fine needle biopsy. Technical success is defined as the successful completion of the EUS-guided fine needle biopsy procedure. |
| Rate of procedure-related adverse events | 7 days | Rate of procedure-related adverse events, defined as any adverse event occurring as a result of EUS-guided fine needle biopsy |
| Type of actionable mutations detected on molecular profiling | 7 days | Type of actionable mutations detected on molecular profiling |
Countries
United States
Outcome results
None listed