The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy

NCT02127021 | Completed Phase 4 DMC

• 1 other identifier: H-1401-145-552
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 6

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.

Conditions

Pancreaticoduodenectomy

Keywords

Pancreaticoduodenectomy; Nutritional Status; Quality of Life; Biochemical Marker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from Baseline in Nutritional Status at 3 months after medication

  3 months after medication

• Change from baseline in stool habit at 3 months after medication

  3 months after medication

Study Arms (2)

Norzyme® 40000 IU

EXPERIMENTAL

Single capsule of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal.

Drug: Norzyme® 40000 IU

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

Drug: Placebo

Interventions

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

Also known as: Norzyme

Norzyme® 40000 IU

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Pharmbio Korea Co., Ltd.: collaborator

Study Sites (6)

Seoul National University Bundang Hospital

Seongnam, Bundang-gu, 463-707, South Korea

Location

Center for Liver Cancer, National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Dongguk University Ilsan Medical Center

Goyang, Kyeonggi, 410-773, South Korea

Location

Department of Surgery, Seoul National University College of Medicine

Seoul, 110-744, South Korea

Location

Chung-Ang University Hospital

Seoul, 156-755, South Korea

Location

Kangnam Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31520730 DERIVED

Study Officials

• Jin-Young Jang, M.D., PhD.

  Seoul National University Hospital

  STUDY CHAIR

• Jin-Young Jang, M.D., PhD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 30, 2014
• Study Start: April 1, 2014
• Primary Completion: September 7, 2017
• Study Completion: December 31, 2017
• Last Updated: January 7, 2019

Record last verified: 2017-12

Locations

KR (6)