The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy

January 3, 2019 updated by: Seoul National University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 156-755
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of, 110-744
        • Department of Surgery, Seoul National University College of Medicine
      • Seoul, Korea, Republic of
        • Kangnam Severance Hospital
    • Bundang-gu
      • Seongnam, Bundang-gu, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 410-769
        • Center for Liver Cancer, National Cancer Center
    • Kyeonggi
      • Goyang, Kyeonggi, Korea, Republic of, 410-773
        • Dongguk University Ilsan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after medication
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
3 months after medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Pharmbio Korea Co., Ltd.

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 7, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-1401-145-552

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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