NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051210012

Registered date:26/04/2021

Early Pancrelipase Trial

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPancreatectomy cases
Date of first enrollment29/06/2021
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeChange of albumin level on 12 months after surgery
Secondary OutcomeChange 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 maximumNot applicable
GenderBoth
Include criteria1.Patients planned to pancreatectomy 2.Over 20 years old when informed consent was written 3.Written informed consent by self-judgement
Exclude criteria1.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

Contact

Public contact
Name Hiromitsu Maehira
Address Seta-tsukinowa-cho, Otsu, Shiga Shiga Japan 520-2192
Telephone +81-77-548-2238
E-mail hgsurge1@belle.shiga-med.ac.jp
Affiliation Shiga University of Medical Science
Scientific contact
Name Hiromitsu Maehira
Address Seta-tsukinowa-cho, Otsu, Shiga Shiga Japan 520-2192
Telephone +81-77-548-2238
E-mail hgsurge1@belle.shiga-med.ac.jp
Affiliation Shiga University of Medical Science