Randomized Trial to Evaluate the Optimal Number of Passes Required for Molecular Profiling During Endoscopic Ultrasound-guided Fine Needle Biopsy of Pancreatic Adenocarcinoma
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- STATUS
- Recruiting
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- End date
- Jun 30, 2023
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- participants needed
- 40
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- sponsor
- Orlando Health, Inc.
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
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.
Details
| Condition | Pancreatic Cancer, Pancreatic Neoplasms, Adenocarcinoma of the Pancreas |
|---|---|
| Treatment | 2 passes during EUS-guided fine needle biopsy, 3 passes during EUS-guided fine needle biopsy |
| Clinical Study Identifier | NCT05043532 |
| Sponsor | Orlando Health, Inc. |
| Last Modified on | 28 October 2022 |
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