Condition category
Cancer
Date applied
03/04/2014
Date assigned
29/04/2014
Last edited
29/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Jean Louis Frossard

ORCID ID

Contact details

Service of Gastroenterology and Hepatology
Geneva University Hospital
R G Perret Gentil 14
Geneve
1211
Switzerland

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 measures

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

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

http://www.hcuge.ch

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes