The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy

Pancreaticoduodenectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127021
• Other study ID #: H-1401-145-552
• Status: Completed
• Phase: Phase 4
• Start date: April 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: December 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: December 31, 2017
• Est. primary completion date: September 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreaticoduodenectomy

Intervention

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
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Center for Liver Cancer, National Cancer Center	Goyang	Gyeonggi
Korea, Republic of	Dongguk University Ilsan Medical Center	Goyang	Kyeonggi
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Bundang-gu
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Department of Surgery, Seoul National University College of Medicine	Seoul
Korea, Republic of	Kangnam Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Pharmbio Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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