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NCT Number: NCT02127021

The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy

Up to now, the studies concerning nutritional assessment after pancreatic resection were rare. The low-dose pancreatic enzyme treatment after pancreatectomy showed no significant benefit in terms of nutritional status. This study is a multicenter randomized phase IV study by using high-dose Norzyme® (40,000 IU) to evaluate quality of life and nutritional status after pancreaticoduodenectomy.

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Key information

Conditions

Pancreaticoduodenectomy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital, Seongnam, Bundang-gu, South Korea

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About this study

There are not enough studies evaluating nutritional parameters in patients with pancreatic resection. After pancreatic surgery, there are several ways to improve patient condition in terms of quality of life including nutrition.

In the investigators previous study, pancreatic enzyme supplement through the administration of Norzyme® 25000 IU containing lipase 25000 IU, amylase 22500 IU, and protease 1250 IU after various type of pancreatectomy to improve quality of life and nutritional status failed to prove its effectiveness. After administration of low-dose Norzyme® (25000 IU), some patients showed weight gain, but statistically significant conclusions were not obtained mainly because of various types of pancreatectomy and low supplementary dosage of pancreatic enzyme.

Therefore, the investigators design this study to find out the effect of high-dose Norzyme® (40000 IU) on weight gain, quality of life, stool habit change, and nutritional status in patients with pancreaticoduodenectomy. The investigators will evaluate the effectiveness and adequacy of high-dose pancreatic supplementary treatment through a randomized, placebo-using, single-blinded, and multicenter study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 75 years
  • ECOG performance status : 0,1,2
  • Patients who underwent pancreaticoduodenectomy or pylorus preserving pancreaticoduodenectomy
  • stool elastase ≤200, preoperatively and postoperatively
  • Patients consented to this study

Exclusion criteria

  • Patients with comorbidities such as liver cirrhosis, chronic renal failure, heart failure, and inflammatory bowel disease which can affect the assessment of quality of life or nutritional status
  • Patients underwent major abdominal organ surgery such as gastrectomy and colon resection which can affect the assessment of quality of life or nutritional status
  • Patients with locoregional recurrence or distant metastasis
  • Patients which were not able to progress diet and medication within 10 days after surgery
  • Patients with pork allergy

Treatment and study plan

Norzyme® 40000 IU

Drug

A kind of pancreatic enzyme supplement containing lipase: 40,000 FIP, amylase: 25,000 FIP, and protease: 1,500 FIP Single capsule of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal

Other names: Norzyme

Placebo

Drug

Single capsule of placebo drug with the same appearance of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal.

Primary outcomes

  1. Change from Baseline in body weight at 3 months after medication

    Time frame: 3 months after medication

    Body weight will be measured 3 times during the entire study period, once preoperatively and two times postoperatively. After surgery, weight will be measured before medication and at the 3 months after medication.These serial weight measurements will be analyzed to figure out changes in body weight over time.

Secondary outcomes

  1. Change from Baseline in Nutritional Status at 3 months after medication

    Time frame: 3 months after medication

    To assess the nutritional status of the patient underwent pancreaticoduodenectomy by testing fasting blood glucose, C-peptide, Insulin, Hb A1c, serum protein, serum albumin, serum pre-albumin, and transferrin

  2. Change from baseline in stool habit at 3 months after medication

    Time frame: 3 months after medication

    To check change from baseline in stool habit at 3 months after medication

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Pharmbio Korea Co., Ltd.

Registry information

Official study title

Prospective Study for the Effects of High Dose Pancreatic Enzyme Replacement Therapy on Body Weight, Quality of Life, and Nutritional Assessment After Pancreatoduodenectomy

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 30, 2014
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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