Early Pancrelipase Trial

JRCT ID: jRCTs051210012

Registered date:26/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatectomy cases
• Date of first enrollment: 29/06/2021
• Target sample size: 100
• Study type: Interventional

Intervention(s)

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 surgery

Outcome(s)

• Primary Outcome: Change of albumin level on 12 months after surgery
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude 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

Related Information

• Primary Sponsor: Maehira Hiromitsu