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| ID | Type | Description | Link |
|---|---|---|---|
| 1741103 | Other Identifier | Orlando Health IRB |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two passes performed during EUS-FNB of pancreatic adenocarcinoma | Active Comparator | 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. |
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| Three passes performed during EUS-FNB of pancreatic adenocarcinoma | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 passes during EUS-guided fine needle biopsy | Procedure | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji Young Bang, MD MPH | Orlando Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Health | Orlando | Florida | 32806 | United States |
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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.
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| 3 passes during EUS-guided fine needle biopsy | Procedure | 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. |
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| 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 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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