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Trial registered on ANZCTR


Registration number
ACTRN12620001336976p
Ethics application status
Submitted, not yet approved
Date submitted
7/10/2020
Date registered
11/12/2020
Date last updated
11/12/2020
Date data sharing statement initially provided
11/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled single blinded multicentre trial of polyethylene glycol sealant to the staple line vs staple line alone in distal pancreatectomy.
Scientific title
A randomised controlled single blinded multicentre trial of polyethylene glycol sealant to the staple line vs staple line alone in distal pancreatectomy. Comparing the rate of post operative fistula formation.
Secondary ID [1] 302492 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
PEGDP-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Surgery 319344 0
Condition category
Condition code
Surgery 317300 317300 0 0
Surgical techniques
Oral and Gastrointestinal 317575 317575 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
This investigator-initiated, collaborative, randomised, controlled, single-blinded, multicentre trial will test if the use of a polyethylene glycol (PEG) sealant reduces the rate of postoperative pancreatic fistula (POPF) formation in patients undergoing distal pancreatectomy (DP). Patients will be randomised to receive standard staple closure of pancreas or staple closure plus the use of a polyethylene glycol sealant. The application of the surgical sealant will add 5 minutes to the surgical procedure. This will be administered as a once only application. This will be applied by the surgical investigator. Record of the application will be recorded in the surgical operation report.
Intervention code [1] 318787 0
Treatment: Devices
Comparator / control treatment
Standard of care staple to resection line in pancreas.
Control group
Active

Outcomes
Primary outcome [1] 325359 0
Pancreatic fistula formation determined by data linkage to medical records.
Timepoint [1] 325359 0
Post operative medical records to the time of hospital discharge. Further confirmation will be obtained from outpatient notes.
Secondary outcome [1] 387638 0
Comprehensive Complication Index integrates all complications of the Clavien–Dindo classification (CDC) and offers a metric approach to measure morbidity. All post operative complications including examples such as nausea, pain, development of ileus, renal impairment are given a weighting that calculates a score for each patient. Death will be recorded.
Timepoint [1] 387638 0
Post operative at the date of discharge.

Eligibility
Key inclusion criteria
• 18 years and over
• Disease of the pancreatic body or tail with planned treatment with elective distal pancreatectomy
• Planned open or minimally invasive approach
• Participant able to provide informed consent
• Intraoperative completion of a distal pancreatectomy (with or without splenectomy)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Participation in another trial that might alter the outcome measures of this trial
• Pre or intraoperative signs of obstruction of the pancreatic duct at the head of the gland
• Unable to provide informed consent or expected lack of compliance with postoperative regime
• Distal pancreatic resection with a staple not feasible
• Documented allergy to human serum albumin
• Renal dysfunction (eGFR <35)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
single blind by central randomisation by web based database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The intervention arm will be compared against control for all primary analyses. The chi squared test will be used for binary outcomes (POPF, death). The relative risk (RR) and RR reduction (RRR) with corresponding 95% confidence intervals, will be calculated for these variables. P values will be reported to 2 decimals, with p-values less than 0.01 reported as p < 0.01. Up to date versions of SPSS (Chicago, IL) will be used to conduct analyses. For all tests, 2-sided p-values will be used, with alpha < 0.05 level of significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
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)
NSW,QLD,VIC
Recruitment hospital [1] 17766 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 17767 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [3] 17768 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [4] 17769 0
Epworth Richmond - Richmond
Recruitment hospital [5] 17770 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [6] 17771 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [7] 17772 0
Western Private Hospital - Footscray
Recruitment hospital [8] 17773 0
Knox Private Hospital - Wantirna
Recruitment hospital [9] 17774 0
The Northern Hospital - Epping
Recruitment hospital [10] 17775 0
John Fawkner Private Hospital - Coburg
Recruitment hospital [11] 17776 0
The Alfred - Melbourne
Recruitment hospital [12] 17777 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [13] 17778 0
Jessie McPherson Private Hospital - Clayton
Recruitment hospital [14] 17779 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [15] 17780 0
Strathfield Private Hospital - Strathfield
Recruitment hospital [16] 17781 0
Mater Sydney - North Sydney
Recruitment hospital [17] 17782 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [18] 17783 0
St George Private Hospital - Kogarah
Recruitment hospital [19] 17784 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [20] 17785 0
North Shore Private Hospital - St Leonards
Recruitment hospital [21] 17786 0
Prince of Wales Hospital - Randwick
Recruitment hospital [22] 17787 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [23] 17788 0
John Hunter Hospital - New Lambton
Recruitment hospital [24] 17789 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [25] 17790 0
The Wesley Hospital - Auchenflower
Recruitment hospital [26] 17791 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 31628 0
3084 - Heidelberg
Recruitment postcode(s) [2] 31629 0
3144 - Malvern
Recruitment postcode(s) [3] 31630 0
3121 - Richmond
Recruitment postcode(s) [4] 31631 0
3050 - Parkville
Recruitment postcode(s) [5] 31632 0
3000 - Melbourne
Recruitment postcode(s) [6] 31633 0
3011 - Footscray
Recruitment postcode(s) [7] 31634 0
3152 - Wantirna
Recruitment postcode(s) [8] 31635 0
3076 - Epping
Recruitment postcode(s) [9] 31636 0
3058 - Coburg
Recruitment postcode(s) [10] 31637 0
3168 - Clayton
Recruitment postcode(s) [11] 31638 0
2050 - Camperdown
Recruitment postcode(s) [12] 31639 0
2135 - Strathfield
Recruitment postcode(s) [13] 31640 0
2060 - North Sydney
Recruitment postcode(s) [14] 31641 0
2217 - Kogarah
Recruitment postcode(s) [15] 31642 0
2065 - St Leonards
Recruitment postcode(s) [16] 31643 0
2031 - Randwick
Recruitment postcode(s) [17] 31644 0
2010 - Darlinghurst
Recruitment postcode(s) [18] 31645 0
2305 - New Lambton
Recruitment postcode(s) [19] 31646 0
2290 - Gateshead
Recruitment postcode(s) [20] 31647 0
4066 - Auchenflower
Recruitment postcode(s) [21] 31648 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 306919 0
Other Collaborative groups
Name [1] 306919 0
Institute for Breathing and Sleep
Address [1] 306919 0
Level 5 Harold Stokes Building Austin Health 145 Studley Road Heidelberg VIC 3084
Country [1] 306919 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Institute for Breathing and Sleep
Address
Level 5 Harold Stokes Building Austin Health 145 Sutdley Road Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 307477 0
None
Name [1] 307477 0
Address [1] 307477 0
Country [1] 307477 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307069 0
Austin Health
Ethics committee address [1] 307069 0
Level 8 Harold Stokes building Austin Health 145 Studley Road Heidelberg VIC 3084
Ethics committee country [1] 307069 0
Australia
Date submitted for ethics approval [1] 307069 0
28/10/2020
Approval date [1] 307069 0
Ethics approval number [1] 307069 0

Summary
Brief summary
Distal pancreatectomy is a surgical procedure commonly used to remove tumours in the body and tail of the pancreas. Postoperative pancreatic fistula formation, where fluid leaks from the remaining pancreas into the abdomen, is the most common and significant surgical complication after this surgery. This can lead to further complications such as intra-abdominal abscess, bleeding, sepsis, and delayed emptying of the stomach. Different techniques have been tried to reduce the rate of POPF. The most successful to date is the use of staples to close the cut edge of the pancreas but the rate of fistula formation continues to be clinically significant. Polyethylene glycol sealants have been successfully used in lung resection surgery to stop air leaks. This type of sealant has not been tested in pancreatic surgery. This study will examine if a polyethylene glycol sealant reduces the rate of postoperative pancreatic fistula formation when used in conjunction with stapling to seal the pancreas.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105918 0
A/Prof Mehrdad Nikfarjam
Address 105918 0
Institute for Breathing and Sleep
Level 5 Harold Stokes Building
Austin Health
145 Studley Road Heidelberg VIC 3084
Country 105918 0
Australia
Phone 105918 0
+61 3 9496 5000
Fax 105918 0
Email 105918 0
m.nikfarjam@unimelb.edu.au
Contact person for public queries
Name 105919 0
Ms Patty Lin
Address 105919 0
Institute for Breathing and Sleep
Level 5 Harold Stokes Building
Austin Health
145 Studley Road Heidelberg VIC 3084
Country 105919 0
Australia
Phone 105919 0
+61 3 9496 3688
Fax 105919 0
Email 105919 0
patty.lin2@austin.org.au
Contact person for scientific queries
Name 105920 0
A/Prof Mehrdad Nikfarjam
Address 105920 0
Institute for Breathing and Sleep
Level 5 Harold Stokes Building
Austin Health
145 Studley Road Heidelberg VIC 3084
Country 105920 0
Australia
Phone 105920 0
+61 3 9496 5000
Fax 105920 0
Email 105920 0
m.nikfarjam@unimelb.edu.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?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator Mehrdad Nikfarjam at m.nikfarjam@unimelb.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results