Patients who underwent pancreaticoduodenectomy
Conditions
Interventions
Administration of Berizym. Patients assigned to the standard treatment group start taking Berizym, which is conventional compound of digestive enzymes within 3 days after registration. Daily amount o
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who underwent pylorus preserving pancreaticoduodenectomy (PPPD) or substomach preserving pancreaticoduodenectomy (SSPPD) for periampullary tumor regardless of benign or malignant tumor including pancreas tumor, extrahepatic bile duct tumor, ampullary tumor, or duodenal tumor. 2) Patients who have started diet intake. 3) Age at the time of registration is between 20 and 80 years old. 4) Within 60 days after pancreaticoduodenectomy. 5) ECOG performance status is 0 or 1. 6) Blood examination performed within 30 days before registration satisfy all of the following criterion. Leukocyte count (WBC) >= 3000 m3 Hemoglobin (Hb) >= 8.0 g/dl Platelet count >= 50,000 /mm3 Total bilirubin <= 2.0 mg/dl Creatinine <= 1.5 mg/dl 7) No hepatic steatosis confirmed by nonenhanced abdominal CT (attenuation of liver >= 40 HU) performed within 30 days before registration. 8) Patients with written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with history of taking any kind of digestive enzymes such as pancrelipase, berizym, excelase, or pancreatin within one year before registration. 2) Patients with history of allergy to bovine or porcine protein. 3) Patients with gastrointestinal comorbidities associated with malabsorption such as inflammatory bowel disease, short bowel syndrome, refractory gastrointestinal ulceration, or gastrointestinal stenosis due to esophageal, gastric or colorectal cancer. 4) Patients with history of esophagectomy of gastrectomy. 5) Patients with history of allergy to Berizym or pancrelipase. 6) Patients considered by attending doctors or psychiatrist to be unsuitable for registration due to psychological condition. 7) Pregnant or suspiciously pregnant women. 8) Patients considered by attending doctors to be unsuitable for enrollment due to any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic steatosis free survival rate one year after the registration calculated as time to event | — |
Secondary
| Measure | Time frame |
|---|---|
| Following variables 3, 6, 9, and 12 months after the registration. 1. body weight, 2. worsening of diarrhea according to the definition of CTCAE-v4.0, 3. serum albumin value, 4. serum total cholesterol value, 5. serum triglyceride value, 6. serum total bilirubin value, 7. serum glutamate oxaloacetate transaminase value, 8. serum glutamic pyruvic transaminase value, 9. serum choline esterase value, 10. serum glycohemogrobin value. In addition, incicence of diabetes mellitus, complianace of drug administration, overall survival, and cumulative incidence of hepatic steatosis one year after the regsitration. | — |
Countries
Japan
Contacts
Public ContactKazuaki Shimada
National Cancer Center Hospital Hepatobiliary and Pancreatic Surgery Division
Outcome results
None listed