UMIN-CTR Clinical Trial

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

Gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Interventional

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

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

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

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

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

Institute

Fukuoka University Central Research Institute for Endoscopy

Institute

Department

Personal name

Organization

Fukuoka University Central Research Institute for Endoscopy

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福岡大学筑紫病院

Date of disclosure of the study information

2013

Year

04

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

04

Month

17

Day

Last modified on

2015

Year

06

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012284