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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010516
Receipt No. R000012284
Scientific Title Randomized controlled trial to investigate usefulness of lipid emulsion loading test for endoscopic diagnosis of gastric early epithelial neoplasia
Date of disclosure of the study information 2013/04/22
Last modified on 2015/06/11

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Basic information
Public title Randomized controlled trial to investigate usefulness of lipid emulsion loading test for endoscopic diagnosis of gastric early epithelial neoplasia
Acronym Ice cream loading test
Scientific Title Randomized controlled trial to investigate usefulness of lipid emulsion loading test for endoscopic diagnosis of gastric early epithelial neoplasia
Scientific Title:Acronym Ice cream loading test
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate whether or not gastric epithelia neoplasia can absorb external lipids after loading with ice cream
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference in increasing rates of lipid droplets (white opaque substance) visualized by magnifying endoscopy with narrow-band imaging between the groups with and without ice-cream loading
Key secondary outcomes Correlation between histological subtype and lipid absorptive neoplasia

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Food
Interventions/Control_1 Oral intake of one cut of Ice-cream with emulsified lipid
Interventions/Control_2 Oral intake of one cup of placebo ice without any lipid
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 1. The patients with gastric cancer or adenoma which were subjected to endoscopic resection
2. The early gastric cancers should meet the criteria of indications for endoscopic resection based on Guidelines by Japanese Cancer Association
3. The patients whose ECOG performance status should be 0 or 1
4. The patients with age 20 years old
5. The patients who can intake a cup of ice cream
6. The patients who gave written informed consent
Key exclusion criteria 1. The neoplasias with erosion, ulceration or bleeding which disturb the endoscopic observation of surface morphology
2. The patients with serious underlying disorders
3. The patients with past history of gastrectomy
4. The patients with lactose intolerance
5. The patients that were determined to be inappropriate to participate in the study by the investigators
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenshi Yao
Organization Fukuoka University Chikushi Hospital
Division name Department of Endoscopy
Zip code
Address 1-1-1 Zokumyoin Chikushino-city Fukuoka
TEL 092-921-1011
Email k.ohtsu0120@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kensei Ohtsu
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1-1 Zokumyoin Chikushino, Japan
TEL 092-921-1011
Homepage URL
Email yao@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Central Research Institute for Endoscopy
Institute
Department

Funding Source
Organization Fukuoka University Central Research Institute for Endoscopy
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 福岡大学筑紫病院

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 22 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 Completed
Date of protocol fixation
2012 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 13 Day
Last follow-up date
2014 Year 07 Month 31 Day
Date of closure to data entry
2015 Year 06 Month 10 Day
Date trial data considered complete
2015 Year 06 Month 11 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 17 Day
Last modified on
2015 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012284

Research Plan
Registered date File name

Research case data specifications
Registered date File name
2015/06/11 150611ラクトアイス負荷試験解析手順.docx

Research case data
Registered date File name
2015/06/11 150611ラクトアイス試験データ一覧UMIN登録.xlsx


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