The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Pancreaticoduodenectomy

Treatments: Drug: Norzyme® 40000 IU; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02127021

H-1401-145-552

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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304 participants in 2 patient groups, including a placebo group

Norzyme® 40000 IU

Experimental group

Description:

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

Treatment:

Drug: Norzyme® 40000 IU

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo