UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility of capsule endoscopy for the screening of small intestinal lesions in patients with familial adenomatous polyposis
Title of the study (Brief title)	Feasibility of capsule endoscopy in patients with familial adenomatous polyposis
Region	Japan

Condition
Condition	Familial adenomatous polyposis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the current study is to evaluate a feasibility of capsule endoscopy in familial adenomatous polyposis patients who had previously undergone colorectal surgery.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Feasibility of capsule endoscopy
Key secondary outcomes	Evaluation of small intestinal lesions in familial adenomatous polyposis patients who had a history of colorectal surgery.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Familial adenomatous polyposis patients who were admitted to our hospital. All patients had undergone colorectal surgery.
Key exclusion criteria	Severe swallowing disorders Pregnancy Implanted cardiac pacemaker Planned MR examination within the next 2week Clinical suspicion of an intestinal obstruction
Target sample size	50

Research contact person
Name of lead principal investigator	Yutaka Saito
Organization	National Cancer Center Hospital
Division name	Endoscopy
Address	5-1-1, Tukiji Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Email	ytsaito@ncc.go.jp

Public contact
Name of contact person	Minori Matsumoto
Organization	National Cancer Center Hospital
Division name	Endoscopy
Address	5-1-1, Tukiji Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Homepage URL
Email	mmatsumo@ncc.go.jp

Sponsor
Institute	Endoscopy Division, National Cancer Center Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	国立がん研究センター中央病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 14 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 02 Month 21 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2015 Year 02 Month 27 Day
Date analysis concluded	2015 Year 06 Month 16 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Capsule endoscopy was offered to 70 consecutive patients who were admitted to our hospital. All patients gave their written informed consent.

Management information
Registered date	2014 Year 01 Month 14 Day
Last modified on	2016 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015007