The Added Value of Contrast Enhancement for Guiding EUS-FNA in Solid Pancreatic Masses

Endoscopic Ultrasonography Clinical Trial

Official title:

The Added Value of Contrast Enhancement for Guiding EUS-FNA in Solid Pancreatic Masses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525847
• Other study ID #: 10430
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Endoscopic Ultrasonography

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