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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014884
Receipt No. R000017308
Scientific Title Effect of early enteral nutrition after video-assisted thoracoscopic esophagectomy for esophageal cancer, a randomized controlled trial
Date of disclosure of the study information 2014/09/01
Last modified on 2015/09/07

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Basic information
Public title Effect of early enteral nutrition after video-assisted thoracoscopic esophagectomy for esophageal cancer, a randomized controlled trial
Acronym Effect of early enteral nutrition after video-assisted thoracoscopic esophagectomy
Scientific Title Effect of early enteral nutrition after video-assisted thoracoscopic esophagectomy for esophageal cancer, a randomized controlled trial
Scientific Title:Acronym Effect of early enteral nutrition after video-assisted thoracoscopic esophagectomy
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this trial is to clarify the necessity of enteral nutrition after video-assisted thoracoscopic esophagectomy which is a less invasive surgery compared with conventional open esophagectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of weight change at postoperative day 14, complications, serum prealbumin level at postoperative day 10
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Jejunostomy and enteral nutrition after surgery
Interventions/Control_2 Venous nutrition after surgery
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
75 years-old >
Gender Male and Female
Key inclusion criteria Patient with elective video-assisted thracoscopic esopagectomy for esophageal cancer.
Patients who consent to this trial.
BMI is 18-25.
Performance status is 1 or 2.
Key exclusion criteria Patient with severe ischemic heart disease, severe cerebrovascular disease, chronic renal falure, electrolyte imbalance, severe diabetes, liver dysfunction, sever obesity, severe emaciation, pregnant, distant metastatis, allergy for Elental and anomaly of amino acid metabolism.
Salvage surgery after chemoradiation therapy for esophageal cancer.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroya Takeuchi
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL +81-3-3353-1211
Email htakeuchi@a6.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroya Takeuchi
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL +81-3-3353-1211
Homepage URL
Email htakeuchi@a6.keio.jp

Sponsor
Institute Department of Surgery, Keio University School of Medicine
Institute
Department

Funding Source
Organization Department of Surgery, Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2011 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 18 Day
Last modified on
2015 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017308

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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