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Trial registered on ANZCTR


Registration number
ACTRN12621000140853
Ethics application status
Approved
Date submitted
8/12/2020
Date registered
11/02/2021
Date last updated
11/02/2021
Date data sharing statement initially provided
11/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the "Hot Spaxus" Lumen Apposing Stent for EUS-guided drainage of pancreatic walled off necrosis
Scientific title
Multicentre, Prospective Evaluation of the "Hot Spaxus" Lumen Apposing Stent for EUS-Guided Drainage of Pancreatic Walled Off Necrosis in Adults
Secondary ID [1] 302207 0
None
Universal Trial Number (UTN)
U1111-1257-8594
Trial acronym
None
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
walled off necrosis 318895 0
hepato-biliary disease 318925 0
gastrointestinal disease 318926 0
necrotising pancreatitis 320305 0
Condition category
Condition code
Oral and Gastrointestinal 316879 316879 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
Endoscopic ultrasound guided insertion of a fully covered lumen apposing stent (Hot SPAXUS) to drain symptomatic walled off necrosis. This intervention takes approximately 15 minutes. The administeration of the intervention will be performed by an expert interventional gastroenterologist in an endoscopy room or theatre room. The patient will be followed up at a minimum to assess clinical progress at 4 weeks and 3 months.
Intervention code [1] 318517 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325005 0
Technical success of insertion of the Hot Spaxus stent based on clinical and endoscopic examination
Timepoint [1] 325005 0
During procedure
Primary outcome [2] 325039 0
30-day post-procedure major adverse events (as defined by the ASGE lexicon for adverse events including cardiovascular, pulmonary, thromboembolic, instrumental, bleeding, infection, drug reaction, pain)
Timepoint [2] 325039 0
Day 30 post procedure
Primary outcome [3] 326207 0
Intra-procedural major adverse events (as defined by the ASGE lexicon for adverse events including cardiovascular, pulmonary, thromboembolic, instrumental, bleeding, infection, drug reaction, pain)
Timepoint [3] 326207 0
During procedure
Secondary outcome [1] 386531 0
Treatment success: Defined by clinical and radiologic resolution (using CT or MRI) of walled off necrosis (WON)
Timepoint [1] 386531 0
3 months
Secondary outcome [2] 386634 0
Other stent-related complications: stent occlusion, migration, tissue over-growth - these will be assessed endoscopically
Timepoint [2] 386634 0
1 month
Secondary outcome [3] 386635 0
Procedure duration (assessed using surgical records)
Timepoint [3] 386635 0
Day 0 (during procedure)
Secondary outcome [4] 386636 0
Stent insertion duration (surgical records will be used to clarify time)
Timepoint [4] 386636 0
Day 0 (during procedure)
Secondary outcome [5] 386637 0
Effect of pre-intervention systemic inflammatory response syndrome (SIRS) - this will be assessed clinically and blood serum samples
Timepoint [5] 386637 0
2 days
Secondary outcome [6] 386638 0
Effect of pre-intervention systemic dysfunction - this will be assessed clinically and blood serum samples
Timepoint [6] 386638 0
2 days
Secondary outcome [7] 386640 0
Pancreatic exocrine insufficiency - using a stool elastase test
Timepoint [7] 386640 0
3 months
Secondary outcome [8] 386641 0
Pancreatic endocrine insufficiency - using a blood serum sample
Timepoint [8] 386641 0
3 months
Secondary outcome [9] 386642 0
Wound infections - based on physician examination
Timepoint [9] 386642 0
3 months
Secondary outcome [10] 386643 0
Number of endoscopic interventions and direct endoscopic necrosectomies (medical records will be reviewed to assess this)
Timepoint [10] 386643 0
3 months
Secondary outcome [11] 386644 0
Length of hospital stay (medical records will be reviewed to assess this)
Timepoint [11] 386644 0
Number of days between index intervention and discharge from hospital.
Secondary outcome [12] 386645 0
Length of ICU stay (medical records will be reviewed to assess this)
Timepoint [12] 386645 0
3 months
Secondary outcome [13] 386646 0
Treatment failure (based on clinical assessment, endoscopic evaluation and MRI/CT)
Timepoint [13] 386646 0
3 months
Secondary outcome [14] 386647 0
Readmission related to the walled off necrosis (WON) - this will be assessed using medical records
Timepoint [14] 386647 0
3 months
Secondary outcome [15] 386648 0
Presence of and management of a disconnected pancreatic duct (composite secondary outcome) - assessed using an endoscopic ultrasound +/- CT/MRI
Timepoint [15] 386648 0
3 months

Eligibility
Key inclusion criteria
1. Aged 18 years old and over, and
2. Medically fit for anaesthesia, and
3. Pancreatic or peri-pancreatic walled off necrosis that is either symptomatic or infected, and
4. Imaging evidence of a WON on MRI or CT, and
5. Informed consent obtained from the patient or legal representative
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Aged under 18 years old
2. Pregnant at enrolment
3. Unable to obtain informed consent from the patient or legal representative
4. Medically unfit for anaesthesia
5. Asymptomatic collection
6. Irreversible coagulopathy: INR > 1.5
7. Irreversible thrombocytopenia: platelet count <50 x 109/L
8. Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
9. WON secondary to trauma or other surgical event that requires additional interventions such as management of liver lacerations or vascular injury
10. Surgical or endoscopic necrosectomy or pseudocyst drainage that has been performed within the preceding 12 months
11. On EUS, located >10mm from GI lumen, immature wall, intervening vessel or structure, WON size <3cm, WON contains >80% solid necrosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This study will begin after obtaining ethics approval at each site. Enrolment will be over a 6-12 month period, until 20 patients have been prospectively enrolled. The study will be completed for each patient at 3-months post EUS-guided WON drainage.

Primary outcomes (as aforementioned) will be reported descriptively using absolute numbers and percentages.
Logistic regression will be used to identify clinical factors that are associated with the primary outcome measures.

Both the categorical & continuous variables (secondary outcomes - as aforementioned) will be expressed as absolute numbers, percentages, means and medians.

STATA is the statistics program that will be used to analyse the results.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/12/2020
Date of last participant enrolment
Anticipated
1/02/2023
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 17426 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 17427 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 17428 0
Westmead Hospital - Westmead
Recruitment hospital [4] 17429 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 17430 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [6] 17431 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 31155 0
3065 - Fitzroy
Recruitment postcode(s) [2] 31156 0
3050 - Parkville
Recruitment postcode(s) [3] 31157 0
2145 - Westmead
Recruitment postcode(s) [4] 31158 0
2170 - Liverpool
Recruitment postcode(s) [5] 31159 0
4029 - Herston
Recruitment postcode(s) [6] 31160 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 306627 0
Hospital
Name [1] 306627 0
St Vincent's Hospital Melbourne
Country [1] 306627 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade, Fitzroy, Victoria, 3065
Country
Australia
Secondary sponsor category [1] 307199 0
None
Name [1] 307199 0
Address [1] 307199 0
Country [1] 307199 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306812 0
St Vincent's Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 306812 0
Ethics committee country [1] 306812 0
Australia
Date submitted for ethics approval [1] 306812 0
02/03/2020
Approval date [1] 306812 0
16/03/2020
Ethics approval number [1] 306812 0
012/20

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105098 0
Dr Bronte Holt
Address 105098 0
St Vincent's Hospital. 41 Victoria Parade, Fitzroy, Victoria, 3065.
Country 105098 0
Australia
Phone 105098 0
+61 419 535 790
Fax 105098 0
Email 105098 0
bronte.holt@svha.org.au
Contact person for public queries
Name 105099 0
Bronte Holt
Address 105099 0
St Vincent's Hospital. 41 Victoria Parade, Fitzroy, Victoria, 3065.
Country 105099 0
Australia
Phone 105099 0
+61 419 535 790
Fax 105099 0
Email 105099 0
bronte.holt@svha.org.au
Contact person for scientific queries
Name 105100 0
Bronte Holt
Address 105100 0
St Vincent's Hospital. 41 Victoria Parade, Fitzroy, Victoria, 3065.
Country 105100 0
Australia
Phone 105100 0
+61 419 535 790
Fax 105100 0
Email 105100 0
bronte.holt@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
This is a study looking at the safety and efficacy of patients undergoing an endoscopic ultrasound guided insertion of the Hot SPAXUS stent. Please see primary and secondary outcomes for further details regarding data that will be collected and shared.
When will data be available (start and end dates)?
Data availability will be from 01/05/2022 to 01/05/2037 (study data will be stored for 15 years)
Available to whom?
In a published format, the data will be available to the public
Available for what types of analyses?
Primary outcomes (as aforementioned) will be reported descriptively using absolute numbers and percentages.
Logistic regression will be used to identify clinical factors that are associated with the primary outcome measures.

Both the categorical & continuous variables (secondary outcomes - as aforementioned) will be expressed as absolute numbers, percentages, means and medians.
How or where can data be obtained?
The data will be presented in a published format either as an article and/or in oral/poster presentations at conferences


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.