UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study for efficacy and safety of capsule endoscopy in children
Title of the study (Brief title)	Prospective study for pediatric capsule endoscopy
Region	Japan

Condition
Condition	Small bowel diseases
Classification by specialty	Gastroenterology Gastrointestinal surgery Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the actual condition of use of capsule endoscopes in children in Japan, and to study its usefulness and safety prospectively in multiple facilities.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total small intestine observation rate
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	0 years-old <=
Age-upper limit	18 years-old >
Gender	Male and Female
Key inclusion criteria	Among Inpatients or outpatients in the hospitals which participate this study, patients who are suspected to have small bowel disease or have known small intestinal diseases, and who will receive capsule endoscopy. 1. Patients younger than 18 years at the time of consent 2. Patients with their or their legal representative's written consent under the free will and sufficient understanding after receiving enough explanation for the participation in this study
Key exclusion criteria	1. Abdominal X-ray examination, abdominal ultrasound examination, history of history, surgical history, clinical findings or other information sugest gastrointestinal obstruction or fistulas. 2. A patient with obvious intestinal stenosis which is expected to cause capsule retention. 3. A patient in which a cardiac pacemaker or other electro-medical device is implanted. 4. A patient with a history of barium-sulfate-induced allergy (for the patients who will recieve patency capsule. 5. patients whom research director or research collaborator judged inappropriate as subjects
Target sample size	200

Research contact person
Name of lead principal investigator	Tsuyoshi Sogo
Organization	Saiseikai Yokohama City Tobu Hospital
Division name	Department of Pediatric Hepatology and Gastroenterology
Address	3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa, Japan
TEL	045-576-3000
Email	t_sogo@tobu.saiseikai.or.jp

Public contact
Name of contact person	Tsuyoshi Sogo
Organization	Saiseikai Yokohama City Tobu Hospital
Division name	Department of Pediatric Hepatology and Gastroenterology
Address	3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa, Japan
TEL	045-576-3000
Homepage URL
Email	t_sogo@tobu.saiseikai.or.jp

Sponsor
Institute	Saiseikai Yokohama City Tobu Hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 05 Month 16 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 01 Month 23 Day
Anticipated trial start date	2017 Year 05 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	1. age, sex, height, body mass index (BMI), history of abdominal surgery 2. purpose of capsule endoscopy (CE) 3. Gastrointestinal endoscopy before CE 4. Balloon asisted enteroscopy 5. Diagnosis before CE and final diagnosis 6. Results of capsule endoscopy 7. Capability of swallowing capsule endoscopy, time for swallowing CE or patency capsule 8. Methods for preperation 9. Intervention after starting CE 10. Grade of bowel cleansing 11. contribution of CE 12. Usage og real time viewer 13. Methods for introducing CE (in cases that patients cannot swallow CE) 14. Time for introducing CE (in cases that patients cannot swallow CE) 15. Outcome and CE retention 16. Adverse events 17. Serum citrulline level 18. serum prealbumin level 19. serum transferrin level 20. serum and urin uric acid and creatinine level, and urinary specific gravity 21. Lewis Score

Management information
Registered date	2017 Year 05 Month 16 Day
Last modified on	2017 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031334