Condition category
Cancer
Date applied
26/03/2013
Date assigned
08/08/2013
Last edited
08/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The global accuracy of fine needle aspiration endoscopic ultrasound (EUS-FNA) for detecting pancreatic adenocarcinoma (cancer of the pancreas) is about 85%. The use of contrast agents (dyes) during EUS may highlight the vessels and the diseased (necrotic) parts of the pancreatic masses, which could lead to obtaining larger and less bloody pancreatic samples.
The aim of the study is to evaluate whether the guidance of fine needle aspiration (FNA) during harmonic contrast-enhanced pancreatic endoscopic ultrasound (CEH-EUS) would increase the diagnostic accuracy of FNA guided by conventional endoscopic ultrasound (EUS) in the same pancreatic masses.

Who can participate?
Both male and female patients, above 18 years old with pancreatic mass.

What does the study involve?
In each prospectively examined patient with pancreatic masses on CT scan, EUS- FNA was performed using a 22 G needle, followed by CEH-EUS using Sonovue as contrast agent. A second cluster of EUS-FNA was performed on contrast image, avoiding vessels and the regions inside the mass considered as necrosis. The final diagnosis was based on the results of EUS-FNA and surgery, or 6 months of follow-up in benign lesions.

What are the possible benefits and risks of participating?
The CEH-EUS allows a better orientation of the needle inside the pancreatic lesion during FNA and possibly increases the yield of diagnostic accuracy in pancreatic masses. There are no risks over normal EUS-FNA of pancreatic masses.

Where is the study run from?
University of Medicine and Pharmacy Cluj Napoca, Romania.
Regional Institute of Gastroenterology and Hepatology Cluj Napoca.

When is the study starting and how long is it expected to run for?
The study started in March 2013 and ran until May 2013.

Who is funding the study?
National Olympus and Aloka-Hitachi.

Who is the main contact?
Andrada Seicean, MD, PhD.

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrada Seicean

ORCID ID

Contact details

15
Closca street
Cluj-Napoca
400039
Romania

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The utility of the Contrast Enhanced endoscopic ultrasound in guiding fine needle aspiration for PANcreatic masses

Acronym

CEPAN

Study hypothesis

The use of the contrast agents during endoscopic ultrasound (EUS) may highlight the vessels and the necrotic parts of the pancreatic masses, which could better to guide sampling.

The aim of the study is to evaluate whether the guidance of fine needle aspiration (FNA) during harmonic contrast-enhanced endoscopic ultrasound of the pancreas would increase the diagnostic accuracy of FNA than FNA guided by conventional endoscopic ultrasound (EUS) in the same pancreatic masses.

Ethics approval

Ethics Board of the Regional Institute of Gastroenterology and Hepatology Cluj-Napoca, Romania, approval 04.12.2012, ref: 15283

Study design

Interventional non-randomized single center study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pancreatic mass

Intervention

This is a non-randomized study. In each prospectively examined patient with pancreatic masses on CT scan, Endoscopic Ultrasound - Fine Needle Aspiration (EUS- FNA) was performed using a 22 G needle, followed by Contrast Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS) using Sonovue as contrast agent. A second cluster of EUS-FNA was performed on contrast image, avoiding vessels and the regions inside the mass considered as necrosis. The final diagnosis was based on the results of EUS-FNA and surgery, or 6 months of follow-up in benign lesions. The pairs of samples (cell blocks), obtained during conventional EUS-FNA and CEH-EUS-FNA, were assessed blindly for macroscopic and microscopic aspects by two pathologists. No cytopathologist was present in the EUS room during the procedure. Qualitative assessment of pancreatic mass after contrast injection was done compared to surrounding parenchyma.

The duration of the intervention up to 30 minutes.

The duration of follow-up - 30 minutes after the procedure

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Diagnostic accuracy of FNA guided by conventional endoscopic ultrasound (EUS)

Secondary outcome measures

Combination of the time to peak obtained by quantitative assessment of the contrast image with CEH-EUS-FNA pathologic results

Overall trial start date

28/03/2013

Overall trial end date

31/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Any gender and age above 18 years old with pancreatic mass. Pancreatic mass detected by ultrasonography or computerised tomography (CT) scan

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40-50

Participant exclusion criteria

1. History of chemotherapy
2. Coagulation disorders
3. Patient’s refuse

Recruitment start date

28/03/2013

Recruitment end date

31/05/2013

Locations

Countries of recruitment

Romania

Trial participating centre

15, Closca street
Cluj-Napoca
400039
Romania

Sponsor information

Organisation

SC Techno Electro Medical Company (Romania)

Sponsor details

69A Calusei street
Bucuresti
021353
Romania

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

The equipment was supported by National Olympus and Aloka-Hitachi companies

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Other devices and the procedures were supported by the hospital: Regional Institute of Gastroenterology and Hepatology Cluj-Napoca (Romania)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes