ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pancreatic lesions

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

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]

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]

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]

This outcome is assessed within 1 day of the procedure.

Secondary outcome [1]

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]

This outcome is assessed within 1 day of the procedure.

Secondary outcome [2]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

25/08/2017

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)

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]

21/06/2017

Ethics approval number [1]

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

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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