Fine-needle aspiration guided by endoscopic ultrasonography (EUS FNA) in pancreatic masses
| ISRCTN | ISRCTN69545565 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69545565 |
| Secondary identifying numbers | Protocol No 09-244 accepted on 27.01.2010 |
- Submission date
- 03/04/2014
- Registration date
- 29/04/2014
- Last edited
- 29/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Fine-needle aspiration guided by endoscopic ultrasonography (EUS-FNA) is a procedure to take a sample of tissue for examination under a microscope. A thin, tube-like instrument called an endoscope with an ultrasound probe and a biopsy needle at the end is inserted through the mouth into the oesophagus (gullet). The ultrasound probe is used to bounce sound waves off internal organs and tissues to make a picture on a monitor, which helps the doctor see where to place the biopsy needle to take a sample. EUS-FNA has changed the way solid pancreatic masses are treated. The aim of this study was to compare the diagnostic accuracy of 25-gauge and a 22-gauge needles in patients with pancreatic solid masses.
Who can participate?
Adults identified to have a pancreatic mass can take part in this study.
What does the study involve?
All patients underwent EUS-FNA using both needles (22-gauge and 25-gauge). The order in which the needles were used were randomly allocated. Half of them had 22-gauge used first and the rest had 25-gauge used first. Tissue samples were analysed for accuracy of diagnosis.
What are the possible benefits and risks of participating?
It is possible that the thinner 25-gauge needle could provide equal or better performance in sampling the pancreas than the 22-gauge needle. It can possibly decrease the risk of FNA-induced bleeding and contamination of the tissue sample.
Where is the study run from?
Geneva University Hospital (Switzerland).
When is the study starting and how long is it expected to run for?
The study started in December 2010 and ran for two years.
Who is funding the study?
Geneva University Hospital (Switzerland) and Cook (Ireland).
Who is the main contact?
Prof. Jean Louis Frossard
jean-louis.frossard@hcuge.ch
Contact information
Scientific
Service of Gastroenterology and Hepatology
Geneva University Hospital
R G Perret Gentil 14
Geneve
1211
Switzerland
Study information
| Study design | Prospective randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | 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 | EUS-guided fine needle aspiration (FNA) in pancreatic masses: a prospective randomized study comparing the yield of 22-gauge and 25-gauge needle in the same patient |
| Study acronym | EUS FNA |
| Study objectives | It remains unclear whether the 22- and 25-gauge needles have equal diagnostic yields in EUS-FNA of pancreatic masses. |
| Ethics approval(s) | Cantonal Commission of Research Ethics [Commission cantonale d'éthique de la recherche (CCER)], 27/01/2010, Ref. 09-244 |
| Health condition(s) or problem(s) studied | Pancreas mass |
| Intervention | EUS FNA The randomization sequence of the needle size was created with a 1:1 allocation using blocks of four without stratification. The allocation was achieved in the operating room by physicians blinded for the allocation sequence, using sequentially numbered, sealed and opaque envelopes. All patients undergo EUS-FNA with a 22-gauge needle and a 25-gauge needle. The order of the needles used is randomised. |
| Intervention type | Other |
| Primary outcome measure | Tissue sample was examined under the microscope. All slides were evaluated for the amount of blood found on the smears, digestive contamination, pancreatic cellularity and final diagnosis. The final diagnosis was based on cytology report, surgical pathology if available, repeated radiological imaging and clinical follow-up. |
| Secondary outcome measures | FNA complications |
| Overall study start date | 01/12/2010 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 45 |
| Key inclusion criteria | Only adults over 18 years were eligible for the study. They all presented to our service with a solid pancreatic mass identified by at least two dissimilar imaging modalities (ultrasound, CT scan, MRI). |
| Key exclusion criteria | 1. Sepsis 2. Acute pancreatitis defined as abdominal pain associated with increased serum lipase > 3 the normal value) 3. Anticoagulant therapy 4. Antiaggregant therapy other than aspirin 5. Previous history of modified anatomy interfering with endoscopic assessment 6. Incapacity to give informed consent |
| Date of first enrolment | 01/12/2010 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
1211
Switzerland
Sponsor information
Hospital/treatment centre
c/o Prof Frossard
Service of Gastroenterology
Rue G Perret Gentil 14
Geneve
1211
Switzerland
| Website | http://www.hcuge.ch |
|---|---|
"ROR" |
https://ror.org/01m1pv723 |
Funders
Funder type
Hospital/treatment centre
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 |
