The utility of the Contrast Enhanced endoscopic ultrasound in guiding fine needle aspiration for PANcreatic masses
| ISRCTN | ISRCTN10282426 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10282426 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/03/2013
- Registration date
- 08/08/2013
- Last edited
- 18/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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.
Contact information
Scientific
15, Closca street
Cluj-Napoca
400039
Romania
Study information
| Study design | Interventional non-randomized single center study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The utility of the Contrast Enhanced endoscopic ultrasound in guiding fine needle aspiration for PANcreatic masses |
| Study acronym | CEPAN |
| Study objectives | 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(s) | Ethics Board of the Regional Institute of Gastroenterology and Hepatology Cluj-Napoca, Romania, approval 04.12.2012, ref: 15283 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 28/03/2013 |
| Completion date | 31/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40-50 |
| Key inclusion criteria | Any gender and age above 18 years old with pancreatic mass. Pancreatic mass detected by ultrasonography or computerised tomography (CT) scan |
| Key exclusion criteria | 1. History of chemotherapy 2. Coagulation disorders 3. Patients refuse |
| Date of first enrolment | 28/03/2013 |
| Date of final enrolment | 31/05/2013 |
Locations
Countries of recruitment
- Romania
Study participating centre
400039
Romania
Sponsor information
Industry
69A Calusei street
Bucuresti
021353
Romania
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2017 | 18/01/2019 | Yes | No |
Editorial Notes
18/01/2019: Publication reference added
