NCT04164017 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Dwyer J, Pantanowitz L, Ohori NP, Pai RK, Vrbin C, Brand RE, Monaco SE
Endoscopic ultrasound-guided FNA and ProCore biopsy in sampling pancreatic and intra-abdominal masses. Cancer Cytopathol. 2016 Feb;124(2):110-21. doi: 10.1002/cncy.21623. Epub 2015 Oct 2.
Lee JK, Choi JH, Lee KH, Kim KM, Shin JU, Lee JK, Lee KT, Jang KT
A prospective, comparative trial to optimize sampling techniques in EUS-guided FNA of solid pancreatic masses. Gastrointest Endosc. 2013 May;77(5):745-51. doi: 10.1016/j.gie.2012.12.009. Epub 2013 Feb 21.
Wallace MB, Kennedy T, Durkalski V, Eloubeidi MA, Etamad R, Matsuda K, Lewin D, Van Velse A, Hennesey W, Hawes RH, Hoffman BJ
Randomized controlled trial of EUS-guided fine needle aspiration techniques for the detection of malignant lymphadenopathy. Gastrointest Endosc. 2001 Oct;54(4):441-7.
Wani S, Muthusamy VR, Komanduri S
EUS-guided tissue acquisition: an evidence-based approach (with videos). Gastrointest Endosc. 2014 Dec;80(6):939-59.e7. doi: 10.1016/j.gie.2014.07.066. Review.
Wani S, Muthusamy VR, McGrath CM, Sepulveda AR, Das A, Messersmith W, Kochman ML, Shah J
AGA White Paper: Optimizing Endoscopic Ultrasound-Guided Tissue Acquisition and Future Directions. Clin Gastroenterol Hepatol. 2018 Mar;16(3):318-327. doi: 10.1016/j.cgh.2017.10.020. Epub 2017 Oct 23. Review.

Comparative Evaluation of the Diagnostic Yield and Sample Quality in Endoscopic Ultrasound(EUS)-Guided Fine Needle Biopsy(FNB) of Pancreatic Solid Lesions With and Without Syringe Suction

Details for clinical trial NCT04164017

Clinical trial NCT04164017 - References