UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016286 |
|---|---|
| Receipt number | R000018893 |
| Scientific Title | Feasibility study of three months enteral nutrition after esophageal surgery |
| Date of disclosure of the study information | 2015/01/21 |
| Last modified on | 2022/01/25 21:27:41 |
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Basic information
Public title
Feasibility study of three months enteral nutrition after esophageal surgery
Acronym
FAST-ERAS Trial
Scientific Title
Feasibility study of three months enteral nutrition after esophageal surgery
Scientific Title:Acronym
FAST-ERAS Trial
Region
| Japan |
Condition
Condition
Thoracic esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Feasibility of three months home enteral nutrition for patient who underwent radical esophagectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of the patients who completed the course
Key secondary outcomes
Body weight, BMI, serum albumin, prealbumin, total cholesterol, lymphocyte count, bioelectrical impedance method for body composition assessment, incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ENEVO (Liquid for Enteral Use) 250ml in a day
90 days
Interventions/Control_2
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
1.Histlogically diagnosed esophageal cancer
2.Clinical stage I, II, III, IV
3.Curative resection (R0)
4.Retrosternal gastric tube reconstruction
5.Gastrotomy
6.Discharge
7.Life expectation >= 6 months
8.No preoperative treatment or only neoadjuvant treatment
9.Written informed consents
Key exclusion criteria
1.Clinically T4
2.Metastasisof distal organ without supraclavicular lymph node metastasis
3.Impossible of home enteral nutrition
4.Pregnant or woman of child bearing potential
5.Doctor's stop not to register to the study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Tsubosa |
Organization
Shizuoka Cancer Center
Division name
Division of Esophageal Surgery
Zip code
411-8777
Address
1007 Shiminagakubo Nagaizumi-cho Shizuoka, Japan
TEL
055-989-5222
y.tsubosa@scchr.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Niihara |
Organization
Kitasato University School of Medicine
Division name
Department of Upper Gastrointestinal Surgery
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
mniihara@med.kitasato-u.ac.jp
Sponsor or person
Institute
Shizuoka Industrial Foundation Pharma Valley Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Industrial Foundation Pharma Valley Center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center Certified Review Board
Address
1007 Shiminagakubo Nagaizumi-cho Shizuoka, Japan
Tel
055-989-5222
rinsho_office@scchr.jp
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
| 2015 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8172505/pdf/10388_2020_Article_803.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8172505/
Number of participants that the trial has enrolled
24
Results
This study enrolled 24 post-esophagectomy
patients between February 2015 and September 2016. Twenty patients were administered 70% or more of the planned nutrient, with 83% of the patients completing the nutritional
intervention procedure.
Results date posted
| 2022 | Year | 01 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 01 | Month | 21 | Day |
Baseline Characteristics
There were 18 males and 6 females, with a
mean age of 61.8 years.
Mean body weight were 57.3 kg. Among the
participants, 7 (29.2%) had stage I disease, 4 (16.7%) had stage II disease, and 13
(54.2%) had stage III disease.
Participant flow
Between February 2015 and September 2016, 24 esophagectomy patients were enrolled in this study.
Adverse events
All 24 patients could be assessed for AEs
during the intervention. There was no grade 3/4 AE. Grade 2 dermatitis caused by the
tape used to fix the tube in place occurred
in 1 patient (4.2%). Grade 1 diarrhea
occurred in 1 patient (1.2%). Both AEs
improved within 2 months.
Outcome measures
The primary outcome measures in this pilot
study were chosen to determine whether or
not the planned home supplemental enteral
tube feeding nutrition would be feasible.
The total planned dose for the whole period was 22,500 mL (27,000 kcal) in 90 cans of
Enevo.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 20 | Day |
Last modified on
| 2022 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018893
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/01/25 | FULL PROTOCOL 改4.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/01/25 | FULL PROTOCOL 改4.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/01/25 | 10388_2020_Article_803.pdf |
