Randomized Trial for Optimal Number of Passes Required for Molecular Profiling During EUS-FNB of Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial to Evaluate the Optimal Number of Passes Required for Molecular Profiling During Endoscopic Ultrasound-guided Fine Needle Biopsy of Pancreatic Adenocarcinoma

Conditions
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Pancreatic Cancer, Pancreatic Neoplasms, Adenocarcinoma of the Pancreas

Intervention / Treatment
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* Procedure: 2 passes during EUS-guided fine needle biopsy
* Procedure: 3 passes during EUS-guided fine needle biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and over Suspected or confirmed pancreatic mass seen on imaging, requiring endoscopic ultrasound-guided fine needle biopsy Exclusion Criteria: Age < 18 years Females who are pregnant Pancreatic mass is not accessible for fine needle biopsy via endoscopic ultrasound Biopsied pancreatic mass is not adenocarcinoma on pathology

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Two passes performed during EUS-FNB of pancreatic adenocarcinoma<br>Once the pancreatic mass is identified on endoscopic ultrasound examination, total of two passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling. | Procedure: 2 passes during EUS-guided fine needle biopsy<br>* 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.<br>|
| Active Comparator: Three passes performed during EUS-FNB of pancreatic adenocarcinoma<br>Once the pancreatic mass is identified on endoscopic ultrasound examination, total of three passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling. | Procedure: 3 passes during EUS-guided fine needle biopsy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy | 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 | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of actionable mutations detected on molecular profiling | Number of actionable mutations detected on molecular profiling | 7 days | 
| Rate of technical success | 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. | 1 day | 
| Rate of procedure-related adverse events | Rate of procedure-related adverse events, defined as any adverse event occurring as a result of EUS-guided fine needle biopsy | 7 days | 
| Type of actionable mutations detected on molecular profiling | Type of actionable mutations detected on molecular profiling | 7 days |