Early Pancrelipase Trial

Randomized controlled trial of postoperative nutritional status according to the dose of pancrelipase in the early postoperative period after pancreatectomy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051210012

Enrollment

100

Registered

2021-04-26

Start date

2021-06-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatectomy cases

Interventions

arm A: Two capsules of Lipacreon (150mg/cap) given on 3 times per day, until 12 months after surgery arm B: Four capsules of Lipacreon (150mg/cap) given on 3 times per day, until 12 months after surge

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients planned to pancreatectomy 2.Over 20 years old when informed consent was written 3.Written informed consent by self-judgement

Exclusion criteria

Exclusion criteria: 1.Patients planned to total pancreatectomy 2.Patients with total gastrectomy 3.Patients with dialysis 4.Patients with liver cirrhosis or medication treatment for hepatitis 5.Pregnant or unwilling to practice contraception during the study 6.Patients with mental illness or psychiatric symptoms 7.Hypersensitivity for pancrelipase or pig protein 8.Inappropriate patients decided by principal or responsible investigator

Design outcomes

Primary

Measure	Time frame
Change of albumin level on 12 months after surgery	—

Secondary

Measure	Time frame
Change of albumin level on 6 months after surgery, Rate of protocol treatment cancellation due to >= 20% of leftover medicine, Rate of increasing the dosage of pancrelipase, Body mass index, albumin level, rate of albumin level of <3.0g/dL, cholinesterase level, total cholesterol level, triglyceride level, total lymphocyte count, prognostic nutritional status, controlled nutritional status score, CT attenuation of the liver, skeletal muscle area at 3rd lumbar vertebra level, and muscle mass on 12 months after surgery, overall survival	—

Measure

Time frame

Change of albumin level on 6 months after surgery, Rate of protocol treatment cancellation due to >= 20% of leftover medicine, Rate of increasing the dosage of pancrelipase, Body mass index, albumin level, rate of albumin level of <3.0g/dL, cholinesterase level, total cholesterol level, triglyceride level, total lymphocyte count, prognostic nutritional status, controlled nutritional status score, CT attenuation of the liver, skeletal muscle area at 3rd lumbar vertebra level, and muscle mass on 12 months after surgery, overall survival

—

Contacts

Public ContactHiromitsu Maehira

Shiga University of Medical Science

hgsurge1@belle.shiga-med.ac.jp+81-77-548-2238

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026