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Trial registered on ANZCTR

Registration number

ACTRN12618000246280

Ethics application status

Approved

Date submitted

5/12/2017

Date registered

15/02/2018

Date last updated

15/02/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Performance of a new preloaded fiducial needle for guided radiation therapy of upper gastrointestinal cancers

Scientific title

Performance of a new preloaded fiducial needle for guided radiation therapy of upper gastrointestinal cancers

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Gastrointestinal Cancers

Condition category

Condition code

Cancer

Oesophageal (gullet)

Cancer

Pancreatic

Cancer

Liver

Cancer

Biliary tree (gall bladder and bile duct)

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Data on patients who underwent EUS-guided fiducial placement for stereotactic body radiotherapy (SBRT) or brachytherapy for gastrointestinal (GI) malignancies were retrospectively and prospectively recruited over 2 years. Visicoil Linear Fiducial Markers (Dosimetry, Schwarzenbruck, Germany) and fiducial bars from the EchoTip Fiducial Needle (Cook Medical, Indiana, United States) were used. Either conventional Viscoils (10mm gold-coils), or the new 22G fiducial needle preloaded with 4x5mm long gold bars were used and the choice was at the discretion of the endoscopists.
For the preloaded system, four 5mm gold bars are part of a 22G needle and are preloaded at the tip of the needle. This allows the fiducials to be deployed to target lesions consecutively in a short amount of time, and avoid the need of withdrawing the needle to load the subsequent fiducials. There are small spaces between the preloaded fiducials, assisting the endoscopist to know when the fiducial is deployed.
In all cases, the procedure was performed with the GF-UCT180 linear echoendoscope (Olympus, Center Valley, PA, USA) and fluoroscopy was used when available. All insertions were done by a single, highly experienced endosonographer with the patients under sedation with Propofol by a specialist anaesthetist. All patients received prophylactic intra-venous anti-biotics during the procedure (Ceftriaxone 1gm or Clindamycin 600mg). The number of fiducials placed was at the discretion of the endosonographer with the aim being 1-4. All patients were monitored for a minimum of 2 hours post-procedure for any early complications and were also advised to contact the centre or doctor for any delayed symptoms suggestive of complications. Patients were also assessed in clinic for any complications 30 days post-procedure.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

The performance of the conventional coil fiducial (Visicoil) will be the control treatment, and will be compared the new EUS preloaded fiducial needle (Cook Medical), for stereotactic body radiotherapy and brachytherapy.

The method for loading and deploying the Visicoil Fiducials required using a 22G or 19G EchoTip needle, which was chosen at the discretion of the endoscopist. This approach requires individual loading of a single fiducial to the tip of a FNA needle prior to each single deployment.
The number of fiducials placed was at the discretion of the endosonographer with the aim being 1-4. These were placed by trained endoscopist using echoendoscope and fluroscopy under anaethesia.
All patients received prophylactic intra-venous anti-biotics during the procedure (Ceftriaxone 1gm or Clindamycin 600mg).

Patients were monitored for a minimum of 2 hours post-procedure for any early complications and assessed 30 days post-operatively.

Control group

Active

Outcomes

Primary outcome [1]

To compare the performance of a new EUS preloaded fiducial needle (Cook Medical) against the conventional coil fiducial (Visicoil) for SBRT and brachytherapy.

This is defined as technical success; the ability to place 1 or more fiducials in the desired location (with endoscopic ultrasound assessment immediately after deployment). The number of fiducials placed was at the discretion of the endosonographer, with the aim being 1-4.

Timepoint [1]

This outcome is assessed within 2 days of the procedure.

Secondary outcome [1]

To compare the number of fiducials placed. The number of fiducials placed was at the discretion of the endosonographer with the aim being 1-4.

Timepoint [1]

This outcome is assessed within 2 days of the procedure.

Secondary outcome [2]

Procedural complications. This includes gastrointestinal perforation, bleeding, post-procedure pancreatitis, infections or seed migration requiring re-insertion.

Timepoint [2]

All patients were monitored for a minimum of 2 hours post-procedure for any early complications and were also advised to contact the centre or doctor for any delayed symptoms suggestive of complications. Patients were also assessed in clinic for any complications 30 days post-procedure.

Secondary outcome [3]

To compare the fiducial insertion time. This is defined as the total time taken to load the fiducials, insert the needle into the lesion and to deploy the fiducials..

Timepoint [3]

This outcome is assessed at the time of the fiducial insertion.

Secondary outcome [4]

To compare fiducial visability. This is assessed by visual analogue scale from 0 to 2, where a score of 0 is not visible, 1 is barely visible, and 2 is clearly visible. The score was assessed from images of CT scans as well as fluoroscopic images.

Timepoint [4]

This outcome is assessed within 2 days of the procedure.

Eligibility

Key inclusion criteria

1. Only patients with gastrointestinal malignancy, confirmed by a cytopathologist.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Pregnancy.

2. Those who cannot provide informed consent.

Study design

Purpose

Duration

Selection

Timing

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

5/12/2017

Date of last participant enrolment

Anticipated

Actual

29/12/2017

Date of last data collection

Anticipated

Actual

5/01/2018

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,
Port Road, Adelaide,
SA 5000

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Adelaide Hospital

Address

Department of Gastroenterology and Hepatology,
Port Road, Adelaide,
SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

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]

Australia

Date submitted for ethics approval [1]

Approval date [1]

04/12/2017

Ethics approval number [1]

HREC/17/RAH/549

Summary

Brief summary

Image guided radiotherapy (IGRT) has recently emerged as a technique for delivering high doses of radiation accurately over a short time span.  It has advantages over conventional external beam radiation (EBRT) by minimising radiation exposure to the surrounding tissues and thus potentially reducing toxicities.  This has been utilised at a variety of sites, including the pancreas, oesophagus, lung and prostate.  Image guidance is best achieved with the implantation of target markers called fiducials or seeds.  These are typically composed of gold and there are currently several available on the market.  In pancreatic cancer, fiducials are superior to biliary stents in terms of showing tumour position.  The technique for implanting fiducials has traditionally been done percutaneously or surgically, but such approach often limited by its invasiveness or the deep location of the cancers such as those from the esophagus or pancreas.  Given the ability of EUS to reach these “difficult” organs, the efficacy and safety of EUS guided fiducial insertion for these GI malignancies have been demonstrated recently.  
The technique of inserting fiducials almost identical to that of FNA/FNB.  Compared to percutaneous method, EUS guided fiducial insertion is likely to associated with a reduction in peritoneal seeding risk and obviates the need to traverse other organs.  Up to now, 10mm gold Visicoils of various diameter is the fiducial system for EUS insertion.  This approach, however, requires individual loading of a single fiducial to the tip of a FNA needle prior to each single deployment, which is tedious and time consuming.  More recently, Cook Medical has specifically designed a dedicated 22G EUS guided fiducial needle with 4 x 5mm gold bars preloaded at the tip of the needle.  This allows the fiducials to be deployed to target lesions consecutively in a short amount of time, and avoid the need of withdrawing the needle to load the subsequent fiducials. In live porcine model, the use of this needle prototype was associated with safety, high technical success rate and high visibility score on fluoroscopy.   

Who can participate?
Recruitment for this study was done on a retrospective and prospective basis. Data on patients who underwent EUS-guided fiducial placement for SBRT or brachytherapy for GI malignancies were recruited over a 4 year period.  Only patients with confirmed malignancy by a cytopathologist and able to give informed consent were included.  

Aim:
The aim of this study is to compare the performance of a new EUS preloaded fiducial needle (Cook Medical) against the conventional coil fiducial (Visicoil) for SBRT and brachytherapy.  

Hypothesis:
It is hypothesized that the new EUS guided preloaded fiducial needle will perform just as well as the conventional coil fiducial, with a 100% technical success rate.

Trial website

Trial related presentations / publications

Public notes

Recruitment for this study was done on a retrospective and prospective basis - hence ethics approval was obtained after a significant proportion of the patients had undergone the procedure.

12 patients were recruited Prospectively, and 43 patients Retrospectively.

Contacts

Principal investigator

Name

Dr Vinh-An Phan

Address

Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Road, Adelaide, South Australia, Australia 5000.

Country

Australia

Phone

+61870742189

Fax

[email protected]

Contact person for public queries

Name

Romina Safaeian

Address

Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Road, Adelaide, South Australia, Australia 5000.

Country

Australia

Phone

+61870742189

Fax

[email protected]

Contact person for scientific queries

Name

Romina Safaeian

Address

Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Road, Adelaide, South Australia, Australia 5000.

Country

Australia

Phone

+61870742189

Fax

[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.

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