UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014884 |
|---|---|
| Receipt number | 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 12:17:13 |
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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
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
htakeuchi@a6.keio.jp
Sponsor or person
Institute
Department of Surgery, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017308
