Endoscopic Ultrasonography Clinical Trial
Official title:
The Added Value of Contrast Enhancement for Guiding EUS-FNA in Solid Pancreatic Masses
NCT number | NCT03525847 |
Other study ID # | 10430 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2017 |
Est. completion date | January 1, 2020 |
Verified date | August 2022 |
Source | Iuliu Hatieganu University of Medicine and Pharmacy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A prospective study designed to show the superiority of contrast guided echoendoscopy versus conventional echoendoscopy
Status | Completed |
Enrollment | 150 |
Est. completion date | January 1, 2020 |
Est. primary completion date | January 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 86 Years |
Eligibility | Inclusion Criteria: - solid pancreatic tumor lesions Exclusion Criteria: - severe coagulopathy of trombocytopenia <50.000 - patients refuse for biopsy prelevation or pacient's refuse to participate in the study |
Country | Name | City | State |
---|---|---|---|
Romania | Seicean Andrada | Cluj-napoca | Cluj |
Lead Sponsor | Collaborator |
---|---|
Professor Dr. Seicean Andrada |
Romania,
Hou X, Jin Z, Xu C, Zhang M, Zhu J, Jiang F, Li Z. Contrast-enhanced harmonic endoscopic ultrasound-guided fine-needle aspiration in the diagnosis of solid pancreatic lesions: a retrospective study. PLoS One. 2015 Mar 20;10(3):e0121236. doi: 10.1371/journal.pone.0121236. eCollection 2015. — View Citation
Seicean A, Jinga M. Harmonic contrast-enhanced endoscopic ultrasound fine-needle aspiration: Fact or fiction? Endosc Ultrasound. 2017 Jan-Feb;6(1):31-36. doi: 10.4103/2303-9027.196917. Review. — View Citation
Yoshinaga S, Suzuki H, Oda I, Saito Y. Role of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for diagnosis of solid pancreatic masses. Dig Endosc. 2011 May;23 Suppl 1:29-33. doi: 10.1111/j.1443-1661.2011.01112.x. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods | Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods | an average of 2 years | |
Secondary | Quality of histological specimen(histology core) obtained with the two types of FNA biopsies (contrast enhanced and standard) | Visual analogic scale | 5 days | |
Secondary | Dysfunction in the two types of biopsies | failure or difficulty reports with each procedure (%) | day one | |
Secondary | Comparison between standand endosonography and contrast enhanced endosonography in obtaining a superior quality in obtaining histology core | Visual analogic scale | day one |
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