UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005082 |
|---|---|
| Receipt number | 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 15:35:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Tohoku University Hospital
Division of Gastrointestinal Surgery
Institute
Department
Personal name
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
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
Value
https://center6.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 |
