UMIN-CTR Clinical Trial

Public title

The Study for the Difference in Gastric Motility between Elemental Diet (Elental) and Oligomeric Formula (Twinline) in the Patients Performed Percutaneous Endoscopic Gastrostomy

Acronym

The Study for the Difference in Gastric Motility between Elemental Diet (Elental) and Oligomeric Formula (Twinline) in the Patients Performed Percutaneous Endoscopic Gastrostomy

Scientific Title

The Study for the Difference in Gastric Motility between Elemental Diet (Elental) and Oligomeric Formula (Twinline) in the Patients Performed Percutaneous Endoscopic Gastrostomy

Scientific Title:Acronym

The Study for the Difference in Gastric Motility between Elemental Diet (Elental) and Oligomeric Formula (Twinline) in the Patients Performed Percutaneous Endoscopic Gastrostomy

Region

Japan

Condition

Dysphasia

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In the patients who were performed percutaneous endoscopic gastrostomy, we investigate the difference in gastric motility between elemental diet (Elental) and oligomeric formula (Twinline).

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Gastric motility examined by ultrasonography (US) after feeding

1) Gastric emptying rate (GER):

GER = [(pyloric antral area (PA) at 1 minute after the end of feeding - PA at 15 minutes after the end of feeding) / PA at 1 minute after the end of feeding] * 100 (%)

We measure the PA by positioning the US probe vertically simultaneously visualized the antrum, superior mesenteric artery, and abdominal aorta.

2) Antral contraction:

Motility Index (MI) = Frequency * Amplitude

Frequency = the number of contractions per 3 minutes

Amplitude = [(PA at the time of relaxation - PA at the time of contraction) / PA at the time of relaxation] * 100 (%)

We calculate MI in 2-5 minutes after the end of feeding.

Key secondary outcomes

Change in blood glucose levels (BG):

The difference between BG before feeding and 30 minutes after the end of feeding

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

In this study, we include the patients who are admitted to our hospital for periodic replacement of gastrostomy catheters under total enteral nutrition.

Key exclusion criteria

We exclude the patients who have any of the following items.

1) vomiting

2) diarrhea (frequency of mushy or watery stool is 3 times a day or more)

3) fever (body temperature is higher than 37.5 degree centigrade)

4) hypoxemia (oxygen saturation measured on room air is less than 92%)

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Yusaku Kajihara

Organization

Fuyoukai Murakami Hospital

Division name

Department of Gastroenterology

Zip code

Address

3-3-14 Hamada, Aomori 030-0843, Japan

TEL

+81-17-729-8888

Email

yukajihara-gi@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Yusaku Kajihara

Organization

Fuyoukai Murakami Hospital

Division name

Department of Gastroenterology

Zip code

Address

3-3-14 Hamada, Aomori 030-0843, Japan

TEL

+81-17-729-8888

Homepage URL

Email

yukajihara-gi@umin.ac.jp

Institute

Fuyoukai Murakami Hospital

Institute

Department

Personal name

Organization

Fuyoukai Murakami Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

Date of disclosure of the study information

2015

Year

04

Month

01

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

Terminated

Date of protocol fixation

2015

Year

03

Month

26

Day

Date of IRB

Anticipated trial start date

2015

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

On admission, we confirm that there are no problems affecting gastric motility in esophagogastroduodenoscopy for the replacement of gastrostomy catheter.

We feed in the early morning after overnight fasting on the 2nd and 3rd hospital day, and examine gastric motility by using a SSA-660A Xario US system (Toshiba, Japan) with a 3.5-MHz convex array transducer. Furthermore, we investigate the change in BG which can relate to gastric emptying.

We number all subjects in turns, and administer Elental (300 mL) on the 2nd hospital day and Twinline (300 mL) on the 3rd hospital day to the patients with odd numbers (administer Twinline (300 mL) on the 2nd hospital day and Elental (300 mL) on the 3rd hospital day to the patients with even numbers). The rate of administration is 250 mL per hour.

We conduct all statistical analyses using EZR (easy R) version 1.23 and consider a p value of <0.05 to be statistically significant. We use the Shapiro-Wilk test for normality and the F test for variance; we also use the two-sided paired t-test or two-sided Wilcoxon signed rank test for the difference between Elental and Twinline.

Registered date

2015

Year

03

Month

27

Day

Last modified on

2016

Year

05

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019554

Single case data URL

Value
https://center6.umin.ac.jp/ice/19554