Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001088336
Ethics application status
Approved
Date submitted
18/07/2017
Date registered
26/07/2017
Date last updated
26/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Objective Method of Assessing Tissue Specimens Obtained via Endoscopic Ultrasound Guided Fine Needle Aspiration.
Scientific title
An objective digital scanning method to quantify and qualify the amount of tissue acquired by different sizes and types of biopsy needles, in patients undergoing endoscopic ultrasound guided fine needle aspiration.
Secondary ID [1] 292425 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Investigation and diagnosis of gastrointestinal tract tissue specimens 304021 0
Condition category
Condition code
Oral and Gastrointestinal 303351 303351 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
An Objective Method of Assessing Tissue Specimens Obtained via Endoscopic Ultrasound Guided Fine Needle Aspiration.

This study does not require patient consent as there will be no risks to the patient and no confidentiality issues (all patients are known to the investigators and the scan have been previously viewed as a part of diagnostic work up). The scans and the data will be stored in an anonymous manner.

The types of needles to be used are Cook Medical Procore Needles, of sizes: 19G, 20G, 22G, and 25G. The anesthetist administers medications, and needle biopsies are taken by the endoscopist. The approximate durations will be approximately 30 minutes, and only 1 type of needle will be used per patient. There is no control group.

The aim of this study, therefore, is to objectively quantify and qualify the amount of tissue acquired by different sizes and types of EUS-guided biopsy needles, using a digital scanning system. In order to objectively quantify the tissue acquired from each needle, pathology slides that have been scanned using the NanoZoomer (Hamamatsu Phototonic, Japan) and stored electronically are examined. Using the associated software (NDP.view2, Phototonic, Japan), the characteristics of the diagnostic tissue are 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 are then objectively quantified by measuring its length, width (or diameter) and total surface area. The quality of the specimen is also assessed by measuring the total surface area of diagnostic tissue in each slide. The volume of each core is estimated using the equation for measuring the volume of a cylinder = “pi x (½ diameter)^2 x length” and the total volume of acquired tissue was calculated for each slide.
Intervention code [1] 298600 0
Diagnosis / Prognosis
Comparator / control treatment
There is no control group. The aim is to objectively quantify and qualify the amount of tissue acquired by different sizes and types of EUS-guided biopsy needles.
Control group
Active

Outcomes
Primary outcome [1] 302814 0
To objectively quantify the amount of tissue acquired by different sizes and types of EUS-guided biopsy needles, using a digital scanning system.
Tissue is acquired from each needle, and pathology slides that have been scanned using the NanoZoomer (Hamamatsu Phototonic, Japan) and stored electronically are examined. The characteristics of the diagnostic tissue are 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 are then objectively quantified by measuring its length, width (or diameter) and total surface area.
Timepoint [1] 302814 0
This outcome is assessed within 1 day of the procedure.
Primary outcome [2] 302815 0
To objectively qualify the amount of tissue acquired by different sizes and types of EUS-guided biopsy needles, using a digital scanning system.
Tissue is acquired from each needle, and pathology slides that have been scanned using the NanoZoomer (Hamamatsu Phototonic, Japan) and stored electronically are examined. The characteristics of the diagnostic tissue are 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 quality of the specimen is assessed by measuring the total surface area of diagnostic tissue in each slide.
Timepoint [2] 302815 0
This outcome is assessed within 1 day of the procedure.
Secondary outcome [1] 336876 0
n/a
Timepoint [1] 336876 0
n/a

Eligibility
Key inclusion criteria
1. Age 18 years old or older
2. Patients requiring diagnostic endoscopic ultrasound with biopsy
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. Those with medical co-morbidities that preclude them from sedation (as determined by anaesthetic team)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Completed
Date of first participant enrolment
Anticipated
Actual
16/02/2017
Date of last participant enrolment
Anticipated
Actual
29/06/2017
Date of last data collection
Anticipated
Actual
29/06/2017
Sample size
Target
90
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 8530 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 16624 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 296984 0
Hospital
Name [1] 296984 0
Royal Adelaide Hospital
Country [1] 296984 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] 295984 0
None
Name [1] 295984 0
N/A
Address [1] 295984 0
N/A
Country [1] 295984 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298182 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 298182 0
Ethics committee country [1] 298182 0
Date submitted for ethics approval [1] 298182 0
Approval date [1] 298182 0
15/02/2017
Ethics approval number [1] 298182 0

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). 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. These needles are designed with an opening on the side and a reverse bevel. Needles also vary in diameter, which range from the largest at 19 gauge (19G) to the smallest at 25 gauge (25G). Studies comparing needles have mainly focused on diagnostic yield and the results between needles has been similar given that only a few cells are needed for diagnoses. However any differences, if found, have frequently been non-significant.
The quantity and quality of diagnostic tissue obtained is becoming increasingly important in the diagnosis and treatment of patients who are suspicious of having a malignant lesion. Equally importantly, a larger specimen would improve specificity of the diagnosis of non-neoplastic conditions, which has been poor with cytological specimens from FNA. Most importantly, the advances in oncological treatment based on histological subtypes, molecular biomarkers and more recently, genomic profile, have demanded the need for larger but good quality specimens for these ancillary tests. This concept has been observed in the management of pancreatico-biliary cancers, and thus, has resulted in development of EUS FNB to acquire larger specimens for these purposes. To our knowledge, there has been no method or criteria to objectively quantify the tissue obtained from different needles. This may explain the indifferences in trials comparing needles thus far.
The NanoZoomer Digital Pathology System (NDP) allows scanning of histology slides with high definition (0.5 µm per pixel). It was developed to allow the digital sharing of slides between pathologists over a network. The associated software (NDP viewer) has the advantage of being able to objectively assess the slides by measuring the width, length and surface area of the tissue.
This is a proof of concept trial to assess the use of the NDP viewer in assessing tissue specimen quality. This can then allow for further trials using this system to directly assess different specimens from different needles on a head to head basis.

Hypothesis:
The differences in the tissue quantity depend on the size and type of needles used in EUS guided biopsies. It is anticipated that the study will provide valuable insights into which needle size is able to obtain the most and highest quality tissue.

Aim:
To objectively quantify and qualify the amount of tissue acquired by different sizes and types of EUS-guided biopsy needles, using a digital scanning system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76246 0
Dr Vinh-An Huu
Address 76246 0
Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000
Country 76246 0
Australia
Phone 76246 0
+61 8 8222 5214
Fax 76246 0
Email 76246 0
[email protected]
Contact person for public queries
Name 76247 0
Ms Romina Safaeian
Address 76247 0
Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000
Country 76247 0
Australia
Phone 76247 0
+61 8 8222 5214
Fax 76247 0
Email 76247 0
[email protected]
Contact person for scientific queries
Name 76248 0
Ms Romina Safaeian
Address 76248 0
Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000
Country 76248 0
Australia
Phone 76248 0
+61 8 8222 5214
Fax 76248 0
Email 76248 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

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