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Trial registered on ANZCTR


Registration number
ACTRN12619000152123
Ethics application status
Approved
Date submitted
8/01/2019
Date registered
1/02/2019
Date last updated
1/02/2019
Date data sharing statement initially provided
1/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Limited Routine Total Parenteral Nutrition versus oral diet progression post Whipple procedure to assess affect on patient functionality
Scientific title
Limited Routine Total Parenteral Nutrition versus oral diet progression post pancreaticoduodenectomy procedure to evaluate the role of parenteral nutrition on Patient functionality
Secondary ID [1] 296988 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pancreatic cancer 310950 0
pancreatitis 310951 0
Cancer: Bowel - small bowel (duodenum and ileum) 310952 0
Condition category
Condition code
Cancer 309616 309616 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 309617 309617 0 0
Pancreatic
Oral and Gastrointestinal 309654 309654 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
All patients will follow the RPA Whipple’s protocol for oral diet progression. Oral diet: NBM day 0-1, Clear Fluid diet day 2-4, Full Fluid diet day 3-5, Post Gastrectomy diet day >4.
Where clear diet is clear liquids only, full fluid diet is opaque liquids only and post gastrectomy diet is a diet and meal frequency appropriate for patients in the early post-operative phase after a gastrectomy or oesophagogastrectomy, and to minimise risk of dumping syndrome or oesophageal blockage (as per NSW Agency of Clinical Innovation diet specifications] .

The intervention group (n = 10) patients will be placed on TPN within 24hrs post pancreaticoduodenectomy with oral diet progression. TPN will be calculated to meet patient’s estimated nutritional requirements using Schofield Equation. TPN will be titrated to goal rate using existing practice as per hospital policy “Parental Nutrition (ICU patients)”.TPN will be given via pre-existing central line inserted pre-op. IV fluids given to intervention arm as per RPA Hospital Pancreaticoduodenectomy Checklist [IVT Day 0 post-operatively use Hartman’s Solution. Chart rate at 150mls/hour and on the ward if a fluid bolus is required, the preference is to use 100mls 20% Albumin]

Diet progression:
Day 0-1: NBM + TPN goal rate
Day 2-4: Clear Fluid diet + TPN goal rate
Day 3-5: Full Fluid diet + TPN half goal rate
Day > 4: Post Gastrectomy diet + TPN half goal rate or ceased
In addition to the above as deeded appropriate by the medical team, the patients may receive: IV fluids to meet hydration needs, oral nutritional supplements as appropriate (if oral intake is inadequate to meet estimated nutritional requirements alone).
The number of days from initial surgery to when the TPN is ceased will be recorded.

Measurement data will be stored via a secure method within REDCap.
The pre-operative and intra-operative data is already collected by the Hospital Upper Gastrointestinal Outcomes database (HUGO) (Protocol No X16-0068 & HREC/16/RPAH/84).

Baseline: Weight, BMI, Grip strength, QOL questionnaire [EQ-5D-5L] and 24hr food recall.
Day 1 post-op: Subjective Global Assessment (SGA)
Day 3: Grip strength, weight, BMI, % weight loss, 24hrs dietary recall on total calorie + protein intake and TPN nutritional contributions. Complications. QOL questionnaire [EQ-5D-5L]. Drain/serum Amylase levels.
Day 5: Drain/serum Amylase levels
Day 7: Grip strength, weight, BMI, % weight loss, 24hrs dietary recall on total calorie + protein intake and TPN nutritional contributions. QOL questionnaire. [EQ-5D-5L].
Day of discharge: postoperative complications and length of stay.
One month post-discharge: number of complication free days, SGA and hand grip strength. To be collected in the Gastro Dietetics Outpatient Clinic.
QOL questionnaire [EQ-5D-5L]
One assessor will be collecting the data; Kiah Witney-Cochrane.
Intervention code [1] 313260 0
Treatment: Other
Comparator / control treatment
Control group (n =10) patients will follow normal oral diet progression post pancreaticoduodenectomy as per the current RPA Hospital Pancreaticoduodenectomy Checklist .
Oral diet progression to commence in ICU and then continue with transfer to the ward.

Diet progression:
Day 0-1: NBM
Day 2-4: Clear Fluid diet
Day 3-5: Full Fluid diet
Day > 4: Post Gastrectomy diet
In addition to the above as deeded appropriate by the medical team, the patients may receive: IV fluids to meet hydration needs, oral nutritional supplements as appropriate (if oral intake is inadequate to meet estimated nutritional requirements alone).

Measurement data will be stored via a secure method within REDCap.
The pre-operative and intra-operative data is already collected by the Hospital Upper Gastrointestinal Outcomes database (HUGO) (Protocol No X16-0068 & HREC/16/RPAH/84).

Baseline: Weight, BMI, Grip strength, QOL questionnaire [EQ-5D-5L] and 24hr food recall.
Day 1 post-op: Subjective Global Assessment (SGA)
Day 3: Grip strength, weight, BMI, % weight loss, 24hrs dietary recall on total calorie + protein intake and TPN nutritional contributions. Complications. QOL questionnaire [EQ-5D-5L]. Drain/serum Amylase levels.
Day 5: Drain/serum Amylase levels
Day 7: Grip strength, weight, BMI, % weight loss, 24hrs dietary recall on total calorie + protein intake and TPN nutritional contributions. QOL questionnaire. [EQ-5D-5L].
Day of discharge: postoperative complications and length of stay.
One month post-discharge: number of complication free days, SGA and hand grip strength. To be collected in the Gastro Dietetics Outpatient Clinic.
QOL questionnaire [EQ-5D-5L]
One assessor will be collecting the data; Kiah Witney-Cochrane.
Control group
Active

Outcomes
Primary outcome [1] 318579 0
The primary aim of this study is to determine the feasibility of providing total parenteral nutrition meeting estimated nutritional requirements versus standard diet progression post pancreaticoduodenectomy.
Timepoint [1] 318579 0
Composite primary outcome: The retention rate will be defined as the percentage of individuals who completed the intervention. This will be determined post discharge of the patient from Royal Prince Alfred Hospital.
Adherence will be defined as the percentage of TPN goal rate reached. Adherence will be calculated at day 4 post randomisation, and will be determined by number of patients in the intervention group who had reached goal rate TPN and the number of days at goal rate.
The goal rate of TPN will be determined in ICU and will be calculated using Schofield Equation specific for the individuals age and gender, with activity factor of 1.0-1.1 and injury factor of 1.2-1.25 and estimated protein requirements using protein targets of 1.2-1.5g/kgBW/day as per ESPEN guideline on clinical nutrition in the intensive care unit.
Secondary outcome [1] 365411 0
Handgrip strength; will be assessed using a dynamometer
Timepoint [1] 365411 0
Will be assessed at baseline, day 3, day 7 and one month post randomisation
Secondary outcome [2] 365412 0
Nutritional status: will be defined using Subjective Global Assessment
Timepoint [2] 365412 0
Will be assessed day one and one month post randomisation
Secondary outcome [3] 365413 0
Total estimate nutritional requirements provided; will be assessed using food diary and / or calculation of provision of total parenteral nutrition provided.
Timepoint [3] 365413 0
Will be assessed at baseline, day 3 and day 7 post randomisation
Secondary outcome [4] 365414 0
Length of hospital stay
Timepoint [4] 365414 0
Will be assessed by the duration of inpatient hospital stay with the day of surgery considered as day 0 until the day of discharged using data linkage to medical records.
Secondary outcome [5] 365415 0
Quality of life; assessed using questionnaire [EQ-5D-5L]
Timepoint [5] 365415 0
Will be assessed at baseline, day 3, day 7 and one month post randomisation
Secondary outcome [6] 365416 0
Composite secondary outcome
Complication rates: will be defined as the total number of complications post-operatively and calculated based on drain/serum Amylase levels
Timepoint [6] 365416 0
Serum amylase will be assessed on day 3 and day 5 post randomisation and final assessment of complication rates will occur on day of discharge.

Eligibility
Key inclusion criteria
- Patients undergoing intended curative pancreaticoduodenectomy at RPAH, inclusive of other extended surgical procedures.
- Ability to provide written consent
- Between 18-99 years of age
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient unable to consent due to language barriers or cognitive function.
- Procedure abandoned due to disease advancement / not clinically indicated upon starting procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomized within 24hrs post-surgery to either control or intervention group. Patients will be randomized via envelope method by an individual not associated with the study. Due to the nature of the study, study participants and investigators will not be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients to be removed from the study if dietary intervention of either enteral or parenteral is required by a patient outside of the study parameters.
Patients with complications requiring take back surgery within 24hrs of initial surgery
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size was based on the number of cases that the UGI consultants at RPA currently conduct during a calendar year. In total the department will see approximately 20 patients undergoing Pancreaticoduodectomy or Pylorus preserving Pancreaticoduodectomy within 1 year. As this is a feasibility study a full sample size calculation has not been performed.

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
Recruitment hospital [1] 12831 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 25300 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 301561 0
Self funded/Unfunded
Name [1] 301561 0
N/A
Address [1] 301561 0
N/A
Country [1] 301561 0
Primary sponsor type
Hospital
Name
Sydney Local Health District
Address
Sydney Local Health District
Royal Prince Alfred Hospital
Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 301261 0
None
Name [1] 301261 0
N/A
Address [1] 301261 0
N/A
Country [1] 301261 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302292 0
Sydney Local Health District Ethics Review Committee (RPAH Zone) [EC00113]
Ethics committee address [1] 302292 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown, NSW 2050
Ethics committee country [1] 302292 0
Australia
Date submitted for ethics approval [1] 302292 0
05/10/2018
Approval date [1] 302292 0
12/12/2018
Ethics approval number [1] 302292 0
HREC/18/RPAH/632

Summary
Brief summary
The purpose of this study is to investigate the effectiveness of two methods of food introduction following a pancreaticoduodenectomy (otherwise known as Whipple procedure).

Who is it for?
You may be eligible for this study if you are aged 18 or over, and are undergoing a pancreaticoduodenectomy (or Whipple procedure) at Royal Prince Alfred Hospital in Sydney.

Study details
Participants will be randomised by chance into two groups. After their planned Whipple procedure, each group will follow a similar nutritional plan, reintroducing foods in a defined manner. One group (the ‘intervention’) will also have nutritional supplementation through a needle in the shoulder placed before surgery. For the 7 days after surgery and one month later, both groups will complete a number of questionnaires and strength tests.
It is hoped this research will demonstrate the feasibility of performing the study and, to see if there is an improvement in a participants overall function if they get the food via a needle compared to the usual diet progression after the surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89722 0
Miss Kiah Witney-Cochrane
Address 89722 0
Royal Prince Alfred Hospital
Building 12, Missenden Rd
Camperdown, NSW 2050
Country 89722 0
Australia
Phone 89722 0
+61 2 9515 4647
Fax 89722 0
+61 2 9515 5047
Email 89722 0
Kiah.WitneyCochrane@health.nsw.gov.au
Contact person for public queries
Name 89723 0
Miss Kiah Witney-Cochrane
Address 89723 0
Royal Prince Alfred Hospital
Building 12, Missenden Rd
Camperdown, NSW 2050
Country 89723 0
Australia
Phone 89723 0
+61 2 9515 4647
Fax 89723 0
+61 2 9515 5047
Email 89723 0
Kiah.WitneyCochrane@health.nsw.gov.au
Contact person for scientific queries
Name 89724 0
Miss Kiah Witney-Cochrane
Address 89724 0
Royal Prince Alfred Hospital
Building 12, Missenden Rd
Camperdown, NSW 2050
Country 89724 0
Australia
Phone 89724 0
+61 2 9515 4647
Fax 89724 0
+61 2 9515 5047
Email 89724 0
Kiah.WitneyCochrane@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 955 0
Study protocol
Citation [1] 955 0
Link [1] 955 0
Email [1] 955 0
Other [1] 955 0
Type [2] 956 0
Other
Citation [2] 956 0
Link [2] 956 0
Email [2] 956 0
Other [2] 956 0
Participant information sheet
Type [3] 957 0
Informed consent form
Citation [3] 957 0
Link [3] 957 0
Email [3] 957 0
Other [3] 957 0
Type [4] 958 0
Ethical approval
Citation [4] 958 0
Link [4] 958 0
Email [4] 958 0
Other [4] 958 0
Summary results
No Results