Clinical trial NCT02127021: The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreaticoduodenectomy
Keywords: Pancreaticoduodenectomy
Nutritional Status
Quality of Life
Biochemical Marker
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Pharmbio Korea Co., Ltd.
First posted: 2014-04-30
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline in body weight at 3 months after medication
timeFrame: 3 months after medication
Secondary outcomes:
measure: Change from Baseline in Nutritional Status at 3 months after medication
timeFrame: 3 months after medication
measure: Change from baseline in stool habit at 3 months after medication
timeFrame: 3 months after medication
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Bundang-gu
city: Goyang
country: Korea, Republic of
facility: Center for Liver Cancer, National Cancer Center
state: Gyeonggi
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Medical Center
state: Kyeonggi
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Seoul National University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam Severance Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Young Jang, M.D., PhD.
role: STUDY_CHAIR
affiliation: Seoul National University Hospital
name: Jin-Young Jang, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.