UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of synthetic ghrelin as a treatment for acute pulmonary complications of patients with esophageal carcinoma who undergo subtotal esophagectomy
Acronym	Feasibility study of synthetic ghrelin as a treatment for acute pulmonary complications of patients with subtotal esophagectomy
Scientific Title	Feasibility study of synthetic ghrelin as a treatment for acute pulmonary complications of patients with esophageal carcinoma who undergo subtotal esophagectomy
Scientific Title:Acronym	Feasibility study of synthetic ghrelin as a treatment for acute pulmonary complications of patients with subtotal esophagectomy
Region	Japan

Condition
Condition	thoracic esophageal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery Chest surgery Endocrine surgery Laboratory medicine Operative medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We aim the drug development of synthetic "ghrelin" as novel anti-inflammatory agent and designed the double blinded, parallelgroup study with fixed three dose regimen, randomized phase 2 study for the proof of concept and dose finding; that was "Feasibility study of synthetic ghrelin as a treatment for acute pulmonary complications of patients with esophageal carcinoma who undergo subtotal esophagectomy"
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	the level of IL-6 concentration in the blood at POD3
Key secondary outcomes	pulmonary complications, duration of SIRS (systemic inflammatory response syndrome), the level of CRP, the level of IL-6 at POD1, 5, 7 and adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	at the same time
Interventions/Control_2	at the same time
Interventions/Control_3	at the same time
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. thoracic esophageal cancer
Key exclusion criteria	1. invasion
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Middle name Last name Doki Yuichiro
Organization	Osaka University Hospital
Division name	Department of Gastroenterological Surgery
Zip code
Address	2-2, Yamadaoka, Suita, Osaka
TEL	06-6879-3251
Email	ydoki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Miyazaki Yasuhiro
Organization	Osaka University Hospital
Division name	Department of Gastroenterological Surgery
Zip code
Address	2-2, Yamadaoka, Suita, Osaka
TEL	06-6879-3251
Homepage URL
Email	ymiyazaki@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Osaka University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	大阪大学医学部附属病院（大阪府）、近畿大学医学部附属病院（大阪府）、大阪府立成人病センター（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date	2017 Year 02 Month 16 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 02 Month 13 Day
Last modified on	2017 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030002

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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