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The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy

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ClinicalTrials.gov Identifier: NCT02127021
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
Pharmbio Korea Co., Ltd.
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreaticoduodenectomy Drug: Norzyme® 40000 IU Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Prospective Study for the Effects of High Dose Pancreatic Enzyme Replacement Therapy on Body Weight, Quality of Life, and Nutritional Assessment After Pancreatoduodenectomy
Study Start Date : April 2014
Actual Primary Completion Date : September 7, 2017
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
Experimental: Norzyme® 40000 IU
Single capsule of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal.
Drug: Norzyme® 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
Other Name: Norzyme

Placebo Comparator: Placebo
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
Drug: Placebo
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127021


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Bundang-gu, Korea, Republic of, 463-707
Center for Liver Cancer, National Cancer Center
Goyang, Gyeonggi, Korea, Republic of, 410-769
Dongguk University Ilsan Medical Center
Goyang, Kyeonggi, Korea, Republic of, 410-773
Department of Surgery, Seoul National University College of Medicine
Seoul, Korea, Republic of, 110-744
Chung-Ang University Hospital
Seoul, Korea, Republic of, 156-755
Kangnam Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Pharmbio Korea Co., Ltd.
Investigators
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Study Chair: Jin-Young Jang, M.D., PhD. Seoul National University Hospital
Principal Investigator: Jin-Young Jang, M.D., PhD. Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02127021     History of Changes
Other Study ID Numbers: H-1401-145-552
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: December 2017
Keywords provided by Seoul National University Hospital:
Pancreaticoduodenectomy
Nutritional Status
Quality of Life
Biochemical Marker