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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005082
Receipt No. R000006041
Scientific Title An Open-Label Prospective Randomized clicical trial to evaluate the Effect of Early Jellied Elemental Diet after Laparoscopically assisted Distal Gastrectomy
Date of disclosure of the study information 2011/04/01
Last modified on 2016/02/15

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Basic information
Public title An Open-Label Prospective Randomized clicical trial to evaluate the Effect of Early Jellied Elemental Diet after Laparoscopically assisted Distal Gastrectomy
Acronym Early Jellied Elemental Diet after Laparoscopically assisted Distal Gastrectomy
Scientific Title An Open-Label Prospective Randomized clicical trial to evaluate the Effect of Early Jellied Elemental Diet after Laparoscopically assisted Distal Gastrectomy
Scientific Title:Acronym Early Jellied Elemental Diet after Laparoscopically assisted Distal Gastrectomy
Region
Japan

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

Objectives
Narrative objectives1 to evaluate the effect of early elemental diet on improvement of bowel function and nutritional status for gastric cancer patients after laparospically assisted gastrectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Shortening of duration of the first defecation after extubation of endotracheal tube
Key secondary outcomes Advantages in Blood test: albumin, pre-albumin, retinol-binding protein, total cholesterol, Zn, Cu
Advantages in Body composition test by InBody S20TM: Body weight, Body mass index, AMC (arm muscle circumference), TSF (triceps skinfolds)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients allocated to trial group take jellied elemental diet (ELENTAL) with/without attached "flavor mix" one pack a day from the 2nd post-operative day to the 7th day.
All the patients including trial group take conventional post-operative meals from the 3rd post-operative day.
Interventions/Control_2 All the patients including trial group take conventional post-operative meals from the 3rd post-operative 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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) A gastric cancer patient diagnosed as clinical stage 1A-2B (Japanese Classification of Gastric Carcinoma The 14th Edition).
2) Planned to receive laparoscopically assisted distal gastrectomy.
3) Planned reconstruction: Gastro-duodenostomy after Billroth 1 or Gastro-jejunostomy after Roux en Y.
4) ECOG Performance Status Scale: 0-1.
5) Greater than or equal to 20 years of age and less than or equal to 80 years of age.
6) Meets the above-mentioned conditions and be able to provide written informed consent.
Key exclusion criteria 1) Neo-adjuvant chemotherapy within four weeks prior to the operation.
2) Coexistence/past history of any inflammatory bowel disease; ulcerative colitis or Crohn's disease.
3) Emergency operation.
4) Double cancer.
5) Combined resection of adjacent intestinal tract
6)Dysfunction of major organs.
7) History of allergic reaction to the components of ELENTAL.
8) Suspect of glucose metabolism disorder with severe diabetes mellitus and/or massive administration of corticosteroids
9) During pregnancy and lactation
10) Aminoacidopathy
11) Swallowing disorder
12) Any other condition that, in the investigator's opinion, places the subject at undue risk by participating in the study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Tanaka
Organization Tohoku University Hospital
Division name Division of Gastrointestinal Surgery
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL 022-717-7205
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Tanaka
Organization Tohoku University Hospital
Division name Division of Gastrointestinal Surgery
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL 022-717-7205
Homepage URL
Email

Sponsor
Institute Tohoku University Hospital
Division of Gastrointestinal Surgery
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor none
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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 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 Terminated
Date of protocol fixation
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2014 Year 11 Month 30 Day
Date of closure to data entry
2014 Year 11 Month 30 Day
Date trial data considered complete
2014 Year 11 Month 30 Day
Date analysis concluded
2014 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 14 Day
Last modified on
2016 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006041

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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