ANZCTR - Registration

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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]

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

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

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]

This outcome is assessed within 1 day of the procedure.

Primary outcome [2]

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]

This outcome is assessed within 1 day of the procedure.

Secondary outcome [1]

n/a

Timepoint [1]

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?

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

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Adelaide Hospital

Address [1]

Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000

Country [1]

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]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

15/02/2017

Ethics approval number [1]

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

Dr Vinh-An Huu

Address

Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000

Country

Australia

Phone

+61 8 8222 5214

Fax

vinh-anhuu.phan@sa.gov.au

Contact person for public queries

Name

Romina Safaeian

Address

Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000

Country

Australia

Phone

+61 8 8222 5214

Fax

romina.safaeian@sa.gov.au

Contact person for scientific queries

Name

Romina Safaeian

Address

Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000

Country

Australia

Phone

+61 8 8222 5214

Fax

romina.safaeian@sa.gov.au

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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Documents added automatically

No additional documents have been identified.

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