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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020890
Receipt No. R000024103
Scientific Title Randomized controlled trial of efficacy of oligomeric formula (HINE E-GEL) vs polymeric formula (MEIN) after esophagectomy for esophageal cancer with ileocolic reconstruction
Date of disclosure of the study information 2016/02/04
Last modified on 2016/02/24

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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 ileocolic reconstruction
Acronym Randomized controlled trial of efficacy of oligomeric formula (HINE E-GEL) vs polymeric formula (MEIN) after esophagectomy for esophageal cancer with ileocolic reconstruction
Scientific Title Randomized controlled trial of efficacy of oligomeric formula (HINE E-GEL) vs polymeric formula (MEIN) after esophagectomy for esophageal cancer with ileocolic 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 ileocolic 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 postopetrative 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 Cluster
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: Ileocolic reconstruction

Written informed consent.
Key exclusion criteria Pt. without enterostomy

Pt. without iliocolic 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 40

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
Email 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
Email yu.ohkura107@gmail.com

Sponsor
Institute Department of Gastroenterological Surgery, Toranomon Hospital
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 04 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 04 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 04 Day
Last modified on
2016 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024103

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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