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Trial registered on ANZCTR


Registration number
ACTRN12617001231336
Ethics application status
Approved
Date submitted
8/08/2017
Date registered
23/08/2017
Date last updated
31/07/2018
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: ProCore vs Shark Core and Acquire
Scientific title
A Head to Head Comparative Pilot Trial to evaluate diagnostic accuracy of EUS Core Biopsy Needles in solid pancreatic lesions: ProCore vs Shark Core and Acquire
Secondary ID [1] 292616 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Lesions 304300 0
Condition category
Condition code
Oral and Gastrointestinal 303654 303654 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 303748 303748 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Head to Head Comparative Pilot Trial of EUS Core Biopsy Needles: ProCore vs Shark Core and Acquire
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, and the subjects will be free to withdraw from the study at any time.
Consenting patients will have the procedure under deep sedation (Propofol), administered by qualified anaesthetists. 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. Each patient will have a single pass using the Shark Core, Acquire and ProCore needles (3 passes total).
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.
Intervention code [1] 298832 0
Diagnosis / Prognosis
Comparator / control treatment
1 pass using the 19G ProCore needle will be the reference standard,
Control group
Active

Outcomes
Primary outcome [1] 303016 0
To determine and compare the core tissue sizes acquired from the different needle groups. 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] 303016 0
This outcome is assessed within 2 days of the procedure.
Primary outcome [2] 303017 0
To determine and compare the sampling adequacy of tissue specimens acquired from each needle type. Trained cytologists and pathologists will assess the final processed samples from each group.
Adequacy is defined as adequate to make a diagnosis, tissue volume also determined by measuring surface area on slides.
Timepoint [2] 303017 0
This outcome is assessed within 2 days of the procedure.
Primary outcome [3] 303018 0
To determine and compare the histological qualities of tissue samples obtained from each needle. Trained cytologists and pathologists (who are blinded to the needle type used) will assess the final processed samples from each group. The qualities of each specimen obtained will be assessed by measuring the surface area of diagnostic tissue in each 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).
Timepoint [3] 303018 0
This outcome is assessed within 2 days of the procedure.
Secondary outcome [1] 337704 0
To determine and compare the diagnostic accuracy of tissue quantities obtained (of pancreatic lesions) between the needle groups. Trained cytologists and pathologists (who are blinded to the needle type used) will assess the final processed samples from each group. Diagnostic accuracy with 1 pass using the 19G ProCore needle will be the reference standard.
Timepoint [1] 337704 0
This outcome is assessed within 2 days of the procedure.
Secondary outcome [2] 337705 0
To determine and compare the complications between the 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] 337705 0
All patients will be observed in recovery for a minimum 2 hours following the procedure for any complications.
Secondary outcome [3] 337706 0
To assess and compare the technical failure between the different needle groups.
This is defined as the inability to insert needle into desired target. Assessed via medical records and with communication with the cytologists and pathologists.
Timepoint [3] 337706 0
All patients will be observed in recovery for a minimum 2 hours following the procedure for any complications. Differences between groups to be compared once sufficient patients have been diagnosed, approximately 1 year within commencement of study.
Secondary outcome [4] 337707 0
To determine the timing of the procedures between the different needles. This outcome is assessed by monitoring and recording time taken during the procedure.
Timepoint [4] 337707 0
Procedure time determined during the procedure. Differences between groups to be compared once sufficient patients have been diagnosed, approximately 1 year within commencement of study.

Eligibility
Key inclusion criteria
1. Age 18 years old or older

2. Patients requiring endoscopic ultrasound and tissue sampling of solid lesions greater than 1cm in diameter in the pancreas, which are visualised and within reach of EUS FNA.
Minimum age
18 Years
Maximum age
No limit
Sex
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
3/09/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 8707 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 16828 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 297243 0
Hospital
Name [1] 297243 0
Royal Adelaide Hospital
Country [1] 297243 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] 296215 0
None
Name [1] 296215 0
Address [1] 296215 0
Country [1] 296215 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298363 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 298363 0
Ethics committee country [1] 298363 0
Australia
Date submitted for ethics approval [1] 298363 0
Approval date [1] 298363 0
27/07/2017
Ethics approval number [1] 298363 0
HREC/17/RAH/59

Summary
Brief summary
The primary purpose of this trial is to compare the efficacy of three types of core biopsy needles used for Endoscopic Ultrasound-Guided (EUS) fine needle biopsy.

Who is it for?
You may be eligible to enroll in this trial if you are aged 18 years old or older and require endoscopic ultrasound and tissue sampling of solid lesions in the pancreas, which are suitable for EUS fine needle aspiration.

Study details
All participants enrolled in this trial will have tissue sampling performed using three different biopsy devices: the ProCore, the Shark Core and Acquire devices. The order in which each device is used will be randomly allocated (by chance). Only a single pass (i.e. a single attempt at sampling) will be completed for each device. The tissue obtained using each device will be stored and analysed by cytologists and pathologists to determine the diagnosis and adequacy of samples obtained using each device.

It is hoped that the findings from this trial will provide information on which of the three devices provides the most sufficient samples for analysis and diagnosis of pancreatic lesions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76838 0
Dr Vinh-An Huu
Address 76838 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Road, Adelaide, SA, 5000
Country 76838 0
Australia
Phone 76838 0
+61 8 7074 2189
Fax 76838 0
Email 76838 0
[email protected]
Contact person for public queries
Name 76839 0
Romina Safaeian
Address 76839 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Road, Adelaide, SA, 5000
Country 76839 0
Australia
Phone 76839 0
+61 8 7074 2189
Fax 76839 0
Email 76839 0
[email protected]
Contact person for scientific queries
Name 76840 0
Romina Safaeian
Address 76840 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Road, Adelaide, SA, 5000
Country 76840 0
Australia
Phone 76840 0
+61 8 7074 2189
Fax 76840 0
Email 76840 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.