UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of the Percutaneus Endoscopic Gastrojejunostomy (PEG-J) tube decompression therapy for patients with chronic intestinal pseudo-obstruction (CIPO)
Title of the study (Brief title)	Efficacy of the PEG-J tube decompression therapy for the CIPO patients
Region	Japan

Condition
Condition	Chronic intestinal pseudo-obstruction(CIPO)
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to assess the decompression effect of the PEG-J tube in patients with CIPO, and establish the novel treatment available at home.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Diameter of the small intestine before and after PEG-J. 2) Frequency of abdominal pain, bloating, and nausea
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Percutaneus endoscopic gastrojejunostomy
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 who meet the diagnostic criteria for CIPO proposed by Ministry of Health, Labor, and Welfare. 2) Patients of whom written informed consent was obtained.
Key exclusion criteria	1) Patients with organic digestive tract disease. 2) Patients with current or past history of malignant disease. 3) Patients with current other digestive diseases. 4) Patients with psychiatric disorders. 5) Patients judged inappropriate for the trial by investigators.
Target sample size	20

Research contact person
Name of lead principal investigator	Atsushi Nakajima
Organization	Yokohama City University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fukuura Kanazawa-ku, Yokohama, Japan
TEL	045-787-2640
Email	nakajima-tky@umin.ac.jp

Public contact
Name of contact person	Hidenori Ohkubo
Organization	Yokohama City University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fukuura Kanazawa-ku, Yokohama, Japan
TEL	045-787-2640
Homepage URL
Email	ohkuboh@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research of Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2015 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 06 Month 01 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

Management information
Registered date	2015 Year 05 Month 14 Day
Last modified on	2018 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020364