UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009455
Receipt number R000011110
Scientific Title Evaluate incidence of gastroesophageal reflux with high viscosity contrast medium.
Date of disclosure of the study information 2012/12/03
Last modified on 2013/12/09 21:28:45

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Basic information

Public title

Evaluate incidence of gastroesophageal reflux with high viscosity contrast medium.

Acronym

Evaluate incidence of gastroesophageal reflux with high viscosity contrast medium.

Scientific Title

Evaluate incidence of gastroesophageal reflux with high viscosity contrast medium.

Scientific Title:Acronym

Evaluate incidence of gastroesophageal reflux with high viscosity contrast medium.

Region

Japan


Condition

Condition

Patients with PEG

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Compare the incidence of gastroesophageal reflux with high (10,000mPa/s) and medium (6,000mPa/s , historical data) viscosity contrast medium.
Also evaluate the factors associated with gastroesophageal reflux.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Incidence of gastroesophageal reflux .

Key secondary outcomes

Incidence of gastroesophageal reflux by hiatus hernia.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

X ray examination with high viscosity contrast medium injected through gastrostoma.

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients older than 20 years.
2)Patients who have given written informed consent by himself or his representative.
3)Patients with PEG

Key exclusion criteria

1)Patients with ileus.
2)Patients with no residual intestinal function.
3)Patients with gastrostoma for decompression.
4)Patients with bronchial incision and bronchial cannula.
5)Patients with pneumonia
6) Patients with a history of upper digestive tract resection. (excluding minor resection such as polypectomy.)
7)Patients with allergy to apple.
8)Patients with a history of hypersensitivity to iodine or iodinated contrast media.
9)Patients who determine inappropriate to enroll clinical study by investigator.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsuya Shimizu

Organization

Saiseikai Matsusaka General Hospital

Division name

Department of Internal Medicine

Zip code


Address

1-15-6 Asahi, Matsusaka city, Mie 515-8557, Japan

TEL

0598-51-2626

Email



Public contact

Name of contact person

1st name
Middle name
Last name Atsuya Shimizu

Organization

Saiseikai Matsusaka General Hospital

Division name

Department of Internal Medicine

Zip code


Address

1-15-6 Asahi, Matsusaka city, Mie 515-8557, Japan

TEL

0598-51-2626

Homepage URL


Email

nst@matsusaka.saiseikai.or.jp


Sponsor or person

Institute

Saiseikai Matsusaka General Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Ishinomaki Senshu University

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

済生会松阪総合病院(三重県)、医療法人清田病院(北海道)、町立長沼病院(北海道)/ Saiseikai Matsusaka General Hospital, Kiyota Hospital, Naganuma municipal Hospital


Other administrative information

Date of disclosure of the study information

2012 Year 12 Month 03 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 11 Month 05 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 03 Day

Last follow-up date

2013 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 12 Month 02 Day

Last modified on

2013 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011110


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name