Pancreaticoduodenectomy
Conditions
Keywords
Pancreaticoduodenectomy, Nutritional Status, Quality of Life, Biochemical Marker
Brief summary
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.
Detailed description
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.
Interventions
DRUGNorzyme® 40000 IU
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
DRUGPlacebo
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.
Sponsors
Pharmbio Korea Co., Ltd.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in body weight at 3 months after medication | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in stool habit at 3 months after medication | 3 months after medication | To check change from baseline in stool habit at 3 months after medication |
| Change from Baseline in Nutritional Status at 3 months after medication | 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 |
Countries
South Korea
Outcome results
None listed