UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016757
Receipt No. R000019442
Scientific Title Effect of Coadministration of Polyethylene Glycol and Dai-Kenchu-To on Image Definition and Complete Small Bowel Examination Rate in Capsule Endoscopy.
Date of disclosure of the study information 2015/03/09
Last modified on 2015/03/09

* 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 Effect of Coadministration of Polyethylene Glycol and Dai-Kenchu-To on Image Definition and Complete Small Bowel Examination Rate in Capsule Endoscopy.
Acronym Effect of PEG and DKT on capsule endoscopy
Scientific Title Effect of Coadministration of Polyethylene Glycol and Dai-Kenchu-To on Image Definition and Complete Small Bowel Examination Rate in Capsule Endoscopy.
Scientific Title:Acronym Effect of PEG and DKT on capsule endoscopy
Region
Japan

Condition
Condition small intestinal lesion
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study was to determine the effect of PEG and DKT pretreatment on image definition and gastrointestinal transit time in capsule endoscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The effect of PEG and DKT pretreatment on image definition and gastrointestinal transit time in capsule endoscopy.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient who is over 20 year-old.
Gender does not matter.
Key exclusion criteria 1) Patients who underwent resection of the small intestine.
2) Patients who used other prokinetics.
3) Patients who underwent endoscopic placement.
4) Patients who diagnosed as having massive small intestinal bleeding by capsule endoscopy.
Target sample size 178

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Hashimoto
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi, Japan
TEL +81-836-22-2241
Email has-333@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Hashimoto
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi, Japan
TEL +81-836-22-2241
Homepage URL
Email has-333@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Coadministration of PEG and DKT improved image definition and prevented a reduction of the complete small bowel examination rate due to PEG in capsule endoscopy.
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
2013 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients who underwent capsule endoscopy at our hospital between November 2007 and August 2012 were included in the study. Patients were divided into the following three groups: those receiving no pretreatment (control, n=133), those orally administered PEG (PEG, n=20), and those orally administered PEG and DKT (15g) (PEG + DKT, n=25). Image definition and complete small bowel examination rate were examined retrospectively between the three groups.
Image definition in the PEG + DKT group was significantly higher than that in the control group (p<0.05), but there was no significant differences between the PEG and control groups. The complete small bowel examination rate was significantly lower in the PEG group than in the control and PEG + DKT groups (p<0.05).

Management information
Registered date
2015 Year 03 Month 09 Day
Last modified on
2015 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019442

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.