UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021056 |
|---|---|
| Receipt number | R000024297 |
| Scientific Title | Randomized controlled trial of efficacy of oligomeric formula (HINE E-GEL) vs polymeric formula (MEIN) after esophagectomy for esophageal cancer with gastric tube reconstruction |
| Date of disclosure of the study information | 2016/02/16 |
| Last modified on | 2017/02/03 11:20:00 |
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Basic information
Public title
Randomized controlled trial of efficacy of oligomeric formula (HINE E-GEL) vs polymeric formula (MEIN) after esophagectomy for esophageal cancer with gastric tube reconstruction
Acronym
Randomized controlled trial of efficacy of oligomeric formula (HINE E-GEL) vs polymeric formula (MEIN) after esophagectomy for esophageal cancer with gastric tube reconstruction
Scientific Title
Randomized controlled trial of efficacy of oligomeric formula (HINE E-GEL) vs polymeric formula (MEIN) after esophagectomy for esophageal cancer with gastric tube reconstruction
Scientific Title:Acronym
Randomized controlled trial of efficacy of oligomeric formula (HINE E-GEL) vs polymeric formula (MEIN) after esophagectomy for esophageal cancer with gastric tube reconstruction
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of oligomeric formula for postoperative diarrhea and nutritional status
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of diarrhea and fecal condition (Bristol stool form scale)
Successful rate of administration of nutrients(7 postoperative days)
Key secondary outcomes
Postoperative complications, Nutrition status (Rapid turnover protein, weight change), Laboratory evidence, Length of stay in intensive care unit, Postoperative hospital stay, Tube obstruction
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 | Food |
Interventions/Control_1
Oligomeric formula
Administration period:
Until postoperative day 7
Dosage:
Start at 10ml/h
10ml/h increase every day
Interventions/Control_2
Polymeric formula
Administration period:
Until postoperative day 7
Dosage:
Start at 10ml/h
10ml/h increase every day
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
Esophageal cancer patients underwent esophagectomy and enterostomy
Reconstruction methods: Gastric tube reconstruction
Written informed consent.
Key exclusion criteria
Pt. without enterostomy
Pt. without gastric tube reconstruction
Pt. with a history of digestive surgery (except appendectomy)
Pt. with colon or other digestive surgery simultaneously
Pt. with an allergic of milk or soy or gelatin including nutrients
Pt. with a tendency for loose stool (at 6 times or more of defecation per day)
No informed consent is obtained
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Harushi Udagawa |
Organization
Toranomon hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan.
TEL
03-3588-1111
udagawah@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Ohkura |
Organization
Toranomon hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan.
TEL
03-3588-1111
Homepage URL
yu.ohkura107@gmail.com
Sponsor or person
Institute
Department of Gastroenterological Surgery, Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery, Toranomon Hospital
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 16 | 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
| 2016 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 16 | 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
| 2016 | Year | 02 | Month | 16 | Day |
Last modified on
| 2017 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024297
