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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2022
Source Iuliu Hatieganu University of Medicine and Pharmacy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A prospective study designed to show the superiority of contrast guided echoendoscopy versus conventional echoendoscopy


Description:

A prospective study that compares the results using FNA contrast echoendoscopy versus standard FNA echoendoscopy in the diagnosis of solid pancreatic tumors


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Endosonography
Puncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. Passage in the same pancreatic mass of first using standard FNA method then contrast enhanced FNA method or vice versa according to the randomization

Locations

Country Name City State
Romania Seicean Andrada Cluj-napoca Cluj

Sponsors (1)

Lead Sponsor Collaborator
Professor Dr. Seicean Andrada

Country where clinical trial is conducted

Romania, 

References & Publications (3)

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

Outcome

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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