UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective randomized study of the nutritional effect by the method of nutrition management after esophagectomy for thoracic esophageal cancer patient
Title of the study (Brief title)	A prospective randomized study of the nutrition management method after esophagectomy
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of total parenteral nutrition and peripheral parenteral nutrition on nutritional status and morbidity rate
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	retinol-binding protein
Key secondary outcomes	post-operative morbidity rate

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	total parental nutrition
Interventions/Control_2	peripheral parental nutrition
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) patients histlogically confirmed esophageal cancer 2) patients planning to undergo right transthoracic esophagectomy, including thoracoscopic esophagectomy 3) patients written informed concent
Key exclusion criteria	1) patients taking contraindication element 2) patients with severe liver disease, renal disease, heart disease, and so on 3) patients with history of severe adverse event due to the drugs using in this study 4) contraindication to the drugs using in this study 5) pregnancy 6) patients judged inadequate to this study by chief doctor
Target sample size	40

Research contact person
Name of lead principal investigator	Yasuaki Nakakjima
Organization	Tokyo Medical and Dental University
Division name	Dept. Esophago-Gastric Surgery
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5254
Email	yasu.nakajima.srg1@tmd.ac.jp

Public contact
Name of contact person	Yasuaki Nakajima
Organization	Tokyo Medical and Dental University
Division name	Dept. Esophago-Gastric Surgery
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5254
Homepage URL
Email	yasu.nakajima.srg1@tmd.ac.jp

Sponsor
Institute	Dept. Esophago-Gastric Surgery, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Dept. Esophago-Gastric Surgery, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 27 Day
Anticipated trial start date	2012 Year 07 Month 30 Day
Last follow-up date	2014 Year 09 Month 10 Day
Date of closure to data entry	2014 Year 10 Month 10 Day
Date trial data considered complete	2014 Year 10 Month 15 Day
Date analysis concluded	2014 Year 11 Month 04 Day

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

Management information
Registered date	2012 Year 07 Month 28 Day
Last modified on	2017 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010056