Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol No 09-244 accepted on 27.01.2010
Study information
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
Acronym
EUS FNA
Study hypothesis
It remains unclear whether the 22- and 25-gauge needles have equal diagnostic yields in EUS-FNA of pancreatic masses.
Ethics approval
Cantonal Commission of Research Ethics [Commission cantonale d'éthique de la recherche (CCER)], 27/01/2010, Ref. 09-244
Study design
Prospective randomized study
Primary study design
Interventional
Secondary study design
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
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
Phase
Not Applicable
Drug names
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 trial start date
01/12/2010
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
45
Participant 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
Recruitment start date
01/12/2010
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Switzerland
Trial participating centre
Service of Gastroenterology and Hepatology
Geneve
1211
Switzerland
Sponsor information
Organisation
Geneva University Hospital (Switzerland)
Sponsor details
c/o Prof Frossard
Service of Gastroenterology
Rue G Perret Gentil 14
Geneve
1211
Switzerland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Geneva University Hospital (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cook (Ireland) - provided needles
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
Basic results (scientific)
Publication list