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| Name | Class |
|---|---|
| Pharmbio Korea Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norzyme® 40000 IU | Experimental | Single capsule of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal. |
|
| Placebo | Placebo Comparator | 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. The formulation and the form of placebo is same with the Norzyme® 40000 IU. Placebo contains microcrystalline cellulose as the main component, titanium oxide, colloidal silica, yellow iron oxide, brown iron oxide, black iron oxide, magnesium stearate, triethyl citrate, talc, and simethicone emulsion in very small amount |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in body weight at 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. | 3 months after medication |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Nutritional Status at 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 | 3 months after medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Young Jang, M.D., PhD. | Seoul National University Hospital | Study Chair |
| Jin-Young Jang, M.D., PhD. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | Bundang-gu | 463-707 | South Korea | ||
| Center for Liver Cancer, National Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31520730 | Derived | Kim H, Yoon YS, Han Y, Kwon W, Kim SW, Han HS, Yoon DS, Park JS, Park SJ, Han SS, Lee SE, Choi SH, Han IW, Kim E, Jang JY. Effects of Pancreatic Enzyme Replacement Therapy on Body Weight and Nutritional Assessments After Pancreatoduodenectomy in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Apr;18(4):926-934.e4. doi: 10.1016/j.cgh.2019.08.061. Epub 2019 Sep 12. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 2, 2020 | |
| Reset | Nov 24, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 2, 2020 | Nov 24, 2020 |
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|
| 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. |
|
| Change from baseline in stool habit at 3 months after medication |
To check change from baseline in stool habit at 3 months after medication |
| 3 months after medication |
| Goyang-si |
| Gyeonggi-do |
| 410-769 |
| South Korea |
| Dongguk University Ilsan Medical Center | Goyang | Kyeonggi | 410-773 | South Korea |
| Department of Surgery, Seoul National University College of Medicine | Seoul | 110-744 | South Korea |
| Chung-Ang University Hospital | Seoul | 156-755 | South Korea |
| Kangnam Severance Hospital | Seoul | South Korea |