RecruitingPhase 4ACTRN12613000269730

Examining the effect of Creon(trademark) on patients who have had an oesphagectomy or gastrectomy.

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)


Sponsor

Box Hill Hospital Department of Surgery

Enrollment

24 participants

Start Date

Jun 27, 2013

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 85 Yearss

Inclusion Criteria1

  • 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.

Exclusion Criteria5

  • 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

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Interventions

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

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.


Locations(1)

Box Hill Hospital - Box Hill

VIC, Australia

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ACTRN12613000269730