Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000269730
Ethics application status
Approved
Date submitted
4/03/2013
Date registered
6/03/2013
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the effect of Creon(trademark) on patients who have had an oesphagectomy or gastrectomy.
Scientific title
Pancreatic Enzyme Replacement Therapy in patients after Major Upper Gastro-Intestinal Operations (PERTUGI) - A Randomized Controlled Trial to Assess Weight Change, Quality of Life, and Faecal Elastase in patients receiving enzyme supplementation with Creon (Trademark)
Secondary ID [1] 282062 0
Nil known
Universal Trial Number (UTN)
U1111-1140-1480
Trial acronym
PERTUGI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic exocrine insufficiency (PEI) 288549 0
Condition category
Condition code
Diet and Nutrition 288877 288877 0 0
Other diet and nutrition disorders
Surgery 288878 288878 0 0
Other surgery
Oral and Gastrointestinal 288879 288879 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
Randomised controlled crossover trial where oral pancreatic replacement therapy (in Australia called Creon) will be compared to placebo. Each study arm will be 4 weeks. Creon will be prescribed at a dose of 40,000 BPU lipase three times daily with meals, and 25,000 BPU with every snacks (from 0 up to a 2 maximum per day). The placebo will physically (as much as possible) represent the active medication and will contain an inert substance.

After the 4 weeks participant will be reviewed and assessed for weight, bowel function, faecal elastase and Quality of life questionnaire. The participant will then have one week 'washout' and then take the other medication of the crossover. The same parameters at the 4 week will then be done again at completion of week 9.
Intervention code [1] 286661 0
Treatment: Drugs
Comparator / control treatment
Placebo: Gelatine capsules filled with microcrystalline cellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 289007 0
Weight: Body mass assessed using the same calibrated digital scales in the Box Hill Hospital Outpatient department.
Timepoint [1] 289007 0
After 4 week and 9 week assessment
Primary outcome [2] 289008 0
Bowel function
Timepoint [2] 289008 0
Participants record daily bowel activity (Bristol stool chart) from baseline until the end of week 9.
Primary outcome [3] 289009 0
Quality of life Questionnaire: FACIT-D
Timepoint [3] 289009 0
After 4 week and 9 week assessment
Secondary outcome [1] 301554 0
Faecal elastase: Faecal assay
Timepoint [1] 301554 0
After 4 week and 9 week assessment

Eligibility
Key inclusion criteria
post major upper gastrointestinal surgery at least 3months, are more than 6 weeks post chemoradiotherapy and are clinically stable. Can provide informed consent to complete the study . It is an expectation that patients included will be able to attend one initial and two follow-up appointments.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who:
- cannot cease alcohol consumption
- whom informed consent cannot be obtained
-those patients with chronic pancreatitis, celiac disease, Chron’s disease and Zollinger-Ellison syndrome
-Any patient who is known to be hypersensitive to porcine protein must also be excluded, as this constitutes the primary active ingredient of the trial medication

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)
Twenty patients post major upper gastrointestinal surgery, who are at least 3 months post surgery and are at least 6 weeks post chemoradiotherapy. Will be recruited for the study from the Box Hill Hospital Upper GI and Hepatobiliary surgical unit outpatient clinic The treating clinician will see the patient in the normal way and identify potential patients for recruitment, based on inclusion and exclusion criteria. After the clinician has completed their consultation with the patient, they will leave the room. The principal researcher will then meet the patient in the consulting room with a written summary of the project and explain the project verbally. The patient will be given an opportunity to ask questions regarding the trial, and may either decide to participate at the time of the initial interview, or take a period of a week or more to make their decision. The principal researcher will take patient’s contact details if they would like to participate or are considering participating, and will likewise provide their contact details. For those patients considering participation, verbal consent will be obtained to contact the patient by phone after one week, to establish their decision. Informed consent in the form of a document requiring the patient’s signature will be obtained at the time of the final decision of the patient. Once a participant has consented, they will be sent to the Box Hill Hospital Pharmacy. Allocation will be conducted by the Box Hill Trial Pharmacist, who will randomised the patients to either container A or B. The principal researcher and the participant will be blinded as to which medication is taken.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In order to successfully randomize participants to commence the treatment or placebo arm and to avoid imbalance in the number of patients assigned to each group, a blocked randomization process will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed by using Chi-squared tests for categorical data and Student’s t test for continuous data (with the assumption of data approximating a Normal distribution and the two samples with equivalent variances). Statistical significance will be considered at P < 0.05 and power will be set at 80%

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2013
Actual
27/06/2013
Date of last participant enrolment
Anticipated
1/12/2018
Actual
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
24
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 709 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 6455 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 286837 0
Hospital
Name [1] 286837 0
Box Hill Hospital Surgical department
Country [1] 286837 0
Australia
Primary sponsor type
Hospital
Name
Box Hill Hospital Department of Surgery
Address
Nelson Road
BOX HILL VIC 3128
Country
Australia
Secondary sponsor category [1] 285626 0
None
Name [1] 285626 0
None
Address [1] 285626 0
Country [1] 285626 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288903 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 288903 0
Eastern Health Office of Research and Ethics
Level 2
5 Arnold Street
Box Hill VIC 3128
Ethics committee country [1] 288903 0
Australia
Date submitted for ethics approval [1] 288903 0
28/03/2013
Approval date [1] 288903 0
25/06/2013
Ethics approval number [1] 288903 0
E49/1213

Summary
Brief summary
This research project is aimed at people who have had major upper gastrointestinal abdominal surgery more than three months ago, are not currently on chemoradiotherapy and who may therefore have symptoms or signs of pancreatic exocrine insufficiency (PEI).

Pancreatic exocrine insufficiency (PEI) occurs when something prevents the pancreas from functioning properly. In the healthy state the pancreas releases substances into the intestinal system to break down the food we eat. In patients with major upper gastrointestinal abdominal surgery this process can be impaired due to changes in the mechanical passage of food, physiological changes from the surgery due to hormonal changes or due to poor function of the pancreas. This means that some patients with major upper gastrointestinal abdominal surgery cannot breakdown fats and so they cannot absorb fats from their food. This results in:

- weight loss
- or inability to gain weight
- non-absorption of essential vitamins found in fats (for example vitamin A, D, E and K)
- unpleasant fatty diarrhoea which is frequent, foul smelling and difficult to flush

Pancreatic enzyme replacement therapy (or PERT) refers to a medication which replaces the most important of the body’s natural pancreatic enzymes and therefore can allow better breakdown and absorption of fats. This may help patients who have had major upper gastrointestinal abdominal surgery to maintain a healthy weight, and have reduction in the unpleasant side effects of frequent diarrhoea. Hence the treatment may reduce weight loss, and malnutrition, and may improve quality of life.

Creon (Trademark) is the trade name of this medication, and is approved in Australia to treat the symptoms discussed already (such as diarrhoea) in patients with evidence of pancreatic exocrine insufficiency. However, it is not always prescribed by specialists and the exact indications for its use have not been fully defined. Therefore, this medication needs to be tested to establish if it is an effective treatment for some of these major upper gastrointestinal abdominal surgery symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38278 0
Dr Mary Ann Johnson
Address 38278 0
c/o Suite 14, Level3, 1 Arnold Street, Box Hill VIC 3128
Country 38278 0
Australia
Phone 38278 0
+61 3 98953333
Fax 38278 0
Email 38278 0
[email protected]
Contact person for public queries
Name 38279 0
Mary Ann Johnson
Address 38279 0
Box Hill Hospital
Nelson Road
BOX HILL VIC 3128
Country 38279 0
Australia
Phone 38279 0
+61 3 98953333
Fax 38279 0
Email 38279 0
[email protected]
Contact person for scientific queries
Name 38280 0
Mary Ann Johnson
Address 38280 0
Box Hill Hospital
Nelson Road
BOX HILL VIC 3128
Country 38280 0
Australia
Phone 38280 0
+61 3 98953333
Fax 38280 0
Email 38280 0
[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

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