UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Perioperative Antioxidant enha nced Nutrition Effect on Liver S urgery
Title of the study (Brief title)	PANEL Study
Region	Japan

Condition
Condition	Liver resection patients
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the effect of periop erative administration of enteral nutrition with anti-oxidants (AO D; ANOM(R)) for liver surgery p atients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Occurrence rate of infectious complications within 14 postoperative days
Key secondary outcomes	1) Changes in antioxidatic effect , 2) Improvement in liver function tests, 3) Changes in perioperative nutritional index, 4) Occurrence rate of infectious complications within 30 postoperative d ays, 5) Length of hospital stay, 6) Adverse effects

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Enteral nutrition with antioxidant supplementation (600 kcal/d ay, ANOM (R)) are given 5 days preoperatively
Interventions/Control_2	Normal enteral nutrition (600 k cal/day for 5 days preoperatively)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient undergoing liver resection including liver cirrhosis cases Over 18 years old Written informed consent is available
Key exclusion criteria	Without conditions as follows: Liver dysfunction like CHild-Pugh C or Liver damage C, Patients with hepatic coma, Patients with severe diabetes, ileus, gastroenteritis, short bowel syndrome, postgastrectomy status Congenital abnormalities in ami no acids metabolism Allergy in milk Allergy in ANOM(R) Pregnancy Responsuble physician diagnose d patients as inapropriate
Target sample size	100

Research contact person
Name of lead principal investigator	HIROYUKI SAKURAI
Organization	MIE UNIVERSITY
Division name	MEDICAL AND NURSING EDUCATION CENTER
Address	2-174 Edobashi, Tsu, Mie, 514- 8507, JAPAN
TEL	059-231-5654
Email	HIRODON@CLIN.MEDIC.MIE-U.AC.JP

Public contact
Name of contact person	HIROYUKI SAKURAI
Organization	MIE UNIVERSITY
Division name	MEDICAL AND NURSING EDUCATION CENTER
Address	2-174 Edobashi, Tsu, Mie, 514- 8507, JAPAN
TEL	059-231-5654
Homepage URL
Email	HIRODON@CLIN.MEDIC.MIE-U.AC.JP

Sponsor
Institute	MIE UNIVERSITY
Institute
Department

Funding Source
Organization	MIE UNIVERSITY
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	三重大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 15 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2010 Year 01 Month 05 Day
Anticipated trial start date	2010 Year 06 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 15 Day
Last modified on	2017 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034235