ANZCTR - Registration

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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]

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)

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Surgery

Other surgery

Oral and Gastrointestinal

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]

Treatment: Drugs

Comparator / control treatment

Placebo: Gelatine capsules filled with microcrystalline cellulose.

Control group

Placebo

Outcomes

Primary outcome [1]

Weight: Body mass assessed using the same calibrated digital scales in the Box Hill Hospital Outpatient department.

Timepoint [1]

After 4 week and 9 week assessment

Primary outcome [2]

Bowel function

Timepoint [2]

Participants record daily bowel activity (Bristol stool chart) from baseline until the end of week 9.

Primary outcome [3]

Quality of life Questionnaire: FACIT-D

Timepoint [3]

After 4 week and 9 week assessment

Secondary outcome [1]

Faecal elastase: Faecal assay

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Box Hill Hospital - Box Hill

Recruitment postcode(s) [1]

3128 - Box Hill

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Box Hill Hospital Surgical department

Address [1]

Nelson Road
BOX HILL VIC 3128

Country [1]

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]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Health Research and Ethics Committee

Ethics committee address [1]

Eastern Health Office of Research and Ethics
Level 2
5 Arnold Street
Box Hill VIC 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/03/2013

Approval date [1]

25/06/2013

Ethics approval number [1]

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

Dr Mary Ann Johnson

Address

c/o Suite 14, Level3, 1 Arnold Street, Box Hill VIC 3128

Country

Australia

Phone

+61 3 98953333

Fax

MaryAnn.Johnson@easternhealth.org.au

Contact person for public queries

Name

Mary Ann Johnson

Address

Box Hill Hospital
Nelson Road
BOX HILL VIC 3128

Country

Australia

Phone

+61 3 98953333

Fax

creonresearch@gmail.com

Contact person for scientific queries

Name

Mary Ann Johnson

Address

Box Hill Hospital
Nelson Road
BOX HILL VIC 3128

Country

Australia

Phone

+61 3 98953333

Fax

majjam888@gmail.com

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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