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

NCT ID: NCT03525847

Last Updated: 2022-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-01-01

Brief Summary

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

Detailed Description

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

Conditions

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Endoscopic Ultrasonography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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contrast enhanced FNA endosonography

First passage in the solid pancreatic tumor using FNA endosonography then with the contrast enhanced FNA endosonography

Group Type ACTIVE_COMPARATOR

Endosonography

Intervention Type DIAGNOSTIC_TEST

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

FNA standard endosonography

First passage in the solid pancreatic tumor using contrast enhanced FNA endosonography then with the FNA endosonography

Group Type ACTIVE_COMPARATOR

Endosonography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Professor Dr. Seicean Andrada

OTHER

Sponsor Role lead

Responsible Party

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Professor Dr. Seicean Andrada

Principal Investigator Proffesor Dr Phd Md

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Seicean Andrada

Role: PRINCIPAL_INVESTIGATOR

Regional Institute of Gastroenterology and Hepatology "Octavian Fodor"Cluj-Napoca

Locations

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Seicean Andrada

Cluj-Napoca, Cluj, Romania

Site Status

Countries

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Romania

References

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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.

Reference Type BACKGROUND
PMID: 25793739 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21535197 (View on PubMed)

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.

Reference Type RESULT
PMID: 28218198 (View on PubMed)

Other Identifiers

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10430

Identifier Type: -

Identifier Source: org_study_id

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