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Trial registered on ANZCTR


Registration number
ACTRN12617001081303
Ethics application status
Approved
Date submitted
13/07/2017
Date registered
26/07/2017
Date last updated
26/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Head to Head Comparative Pilot Trial of Endoscopic ultrasound-guided (EUS)
Core Biopsy Needles in solid pancreatic lesions: 19G ProCore vs 19G EZ Shot 3PLus
Scientific title
A Head to Head Comparative Pilot Trial to evaluate diagnostic accuracy of EUS Core Biopsy Needles in solid pancreatic lesions: 19G ProCore vs 19G EZ Shot 3PLus
Secondary ID [1] 292418 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic lesions 304008 0
Condition category
Condition code
Oral and Gastrointestinal 303339 303339 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Head to Head Comparative Pilot Trial of EUS Core Biopsy Needles: 19G ProCore vs 19G EZ Shot 3Plus.
All aspects of the study will be discussed with each subject during a phone interview or screening visit. An information sheet will be provided, and each subject will be given the opportunity to seek medical advice or to discuss the study with friends or family prior to involvement. Each volunteer will give written, informed consent, in accordance with the attached form.
Consenting patients will have the procedure under deep sedation (Propofol), administered by qualified anaesthetists, and will be performed at the Royal Adelaide Hospital. After the lesion is evaluated by EUS, the endoscopist will perform the tissue sampling using all needles consecutively. The order of the needle passes will be pre-determined in a randomized fashion using a computerized program.
All aspirated material will be placed in formalin (separate pots for each needle) to undergo direct histological processing (filtered through a microcassette, immersed in Ponceau S tinted neutral buffered formalin and processed as standard histological blocks).
All patients will be observed in recovery for a minimum 2 hours following the procedure for any complications. Trained cytologists and pathologists (who are blinded to the needle type used) will assess the final processed samples from each group in order to determine the diagnosis.
In order to objectively quantify the tissue acquired from each needle, the slides will be scanned using the NanoZoomer (Hamamatsu Phototonic, Japan) and high definition images stored electronically. Using the associated software (NDP.view2, Phototonic, Japan), the characteristics of the diagnostic tissue will be examined for the presence of tissue-core (defined as tissue showing preserved architectural integrity, in which the length of the core is at least twice of the nominal inner diameter of the used needle). The tissue-cores will then be objectively quantified by measuring the total core surface area, length and diameter. The quality of the specimen obtained was also assessed by measuring the surface area of diagnostic tissue in each core.
The total number of needle passes per participant is 1 pass using the 19G ProCore, and 1 pass using the 19G EZ Shot 3Plus (i.e. 2 passes in total).
Intervention adherence will not be assessed.
Intervention code [1] 298588 0
Diagnosis / Prognosis
Comparator / control treatment
1 pass using the 19G ProCore needle will be the reference standard, and quantity of diagnostic tissue obtained will be compared to 1 pass using the 19G EZ Shot 3Plus needle.
Control group
Active

Outcomes
Primary outcome [1] 302727 0
To determine and compare the tissue quantities obtained (of solid pancreatic lesions) between the 2 needles.
Trained cytologists and pathologists (who are blinded to the needle type used) will assess the final processed samples from each group.
In order to objectively quantify the tissue acquired from each needle, the slides will be scanned using the NanoZoomer (Hamamatsu Phototonic, Japan) and high definition images stored electronically. Using the associated software (NDP.view2, Phototonic, Japan), the characteristics of the diagnostic tissue will be examined for the presence of tissue-core (defined as tissue showing preserved architectural integrity, in which the length of the core is at least twice of the nominal inner diameter of the used needle). The tissue-cores will then be objectively quantified by measuring the total core surface area, length and diameter.
Timepoint [1] 302727 0
This outcome is assessed within 1 day of the procedure.
Secondary outcome [1] 336868 0
To determine and compare the diagnostic yield of tissue quantities obtained (of solid pancreatic lesions) between the 2 needles.
Trained cytologists and pathologists (who are blinded to the needle type used) will assess the final processed samples from each group.
Diagnostic yield with 1 pass using the 19G ProCore needle will be the reference standard, and will be compared to diagnostic yield of 1 pass using the 19G EZ Shot 3Plus needle.
Timepoint [1] 336868 0
This outcome is assessed within 1 day of the procedure.
Secondary outcome [2] 336870 0
To determine and compare the complications between the 2 needles. This may be any bleeding, perforations etc. that may be associated with the needles.
Given that the use of all devices have already been shown to be a safe method of acquiring pancreatic tissue specimens, this study poses no addition risks to the participants.
This will be assessed via medical records and contact with the patient.
Timepoint [2] 336870 0
All patients will be observed in recovery for a minimum 2 hours following the procedure for any complications.

Eligibility
Key inclusion criteria
1. Patients requiring endoscopic ultrasound and tissue sampling of solid lesions greater than 1cm diameter in the pancreas that are visualized and within the reach of EUS FNA.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant females.
2. Uncorrectable coagulation disorder (INR greater than 1.5).
3. Those with medical co-morbidities that preclude them from sedation (as determined by anaesthetic team).
4. Actively on medications that increase the risk of bleeding from EUS guided tissue acquisition (NOAC, warfarin, combined aspirin and clopidogrel).
5. Those unable to give informed consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 8529 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 16623 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 296967 0
Hospital
Name [1] 296967 0
Royal Adelaide Hospital
Address [1] 296967 0
Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000
Country [1] 296967 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 295974 0
None
Name [1] 295974 0
N/A
Address [1] 295974 0
N/A
Country [1] 295974 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298174 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 298174 0
Ethics committee country [1] 298174 0
Date submitted for ethics approval [1] 298174 0
Approval date [1] 298174 0
21/06/2017
Ethics approval number [1] 298174 0
HREC/17/RAH/72

Summary
Brief summary
Background:
Endoscopic ultrasound fine needle aspiration (EUS FNA) allows cytologic and/or histologic diagnosis of lesions within or adjacent to the gastrointestinal tract (GIT). Several studies have shown this approach to be cost-effective and safe with complication rates less than 2%. EUS FNA also carries a high-diagnostic yield with accuracy ranging from approximately 80-95%. Currently there are multiple different needle types, including the recent development of fine needle biopsy (FNB) needles, which aim to increase the amount of tissue acquired. Studies comparing needles have mainly focused on diagnostic yield as well as complication rates. However any differences, if found, have frequently been non-significant.
The quantity of diagnostic tissue obtained is becoming increasingly important in the work up of cancer patients, where personalised therapy is a goal. Treatment can now be influenced not only by histological subtype, but also based on the presence of molecular markers. In order to sub classify tumours further, adequate tissue samples are needed for both diagnosis and molecular testing. Therefore, when comparing different needle types or sizes, studies should also look at the amount of tissue obtained.
The Echo Tip ProCore is a FNB device with a side-bevel designed to obtain histological cores of tissue. It is well-established, has been extensively studied and shown to be safe and highly accurate. The 19G EZ Shot 3 Plus needle is a newer needle that is also designed to obtain a histological core, with the addition of the flexibility one would expect from a smaller gauge needle. It has been approved by the Australian Register of Therapeutic Goods.

Hypothesis:
The 19G EZ shot 3 Plus needle will obtain equal diagnostic tissue quantity to the ProCore needle in solid pancreatic lesions.

Aim:
To compare the diagnostic accuracy and obtained tissue quantity of 19G EZ shot 3 Plus needle versus the ProCore needle in the investigation of solid pancreatic masses.

Design:
This is a non-inferior paired, prospective, single-centre study involving patients undergoing EUS evaluation of solid pancreatic masses. It will involve 66 patients who will each have a single pass using the EZ shot 3 Plus and ProCore needles (2 passes total).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76222 0
Dr Vinh-An Huu
Address 76222 0
Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000
Country 76222 0
Australia
Phone 76222 0
+61 8 8222 5214
Fax 76222 0
Email 76222 0
Vinh-AnHuu.Phan@sa.gov.au
Contact person for public queries
Name 76223 0
Ms Romina Safaeian
Address 76223 0
Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000
Country 76223 0
Australia
Phone 76223 0
+61 8 8222 5214
Fax 76223 0
Email 76223 0
romina.safaeian@sa.gov.au
Contact person for scientific queries
Name 76224 0
Ms Romina Safaeian
Address 76224 0
Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000
Country 76224 0
Australia
Phone 76224 0
+61 8 8222 5214
Fax 76224 0
Email 76224 0
romina.safaeian@sa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results