UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017574
Receipt number R000020364
Scientific Title Efficacy of the Percutaneus Endoscopic Gastrojejunostomy (PEG-J) tube decompression therapy for patients with chronic intestinal pseudo-obstruction (CIPO)
Date of disclosure of the study information 2015/06/01
Last modified on 2018/10/02 19:38:12

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Basic information

Public title

Efficacy of the Percutaneus Endoscopic Gastrojejunostomy (PEG-J) tube decompression therapy for patients with chronic intestinal pseudo-obstruction (CIPO)

Acronym

Efficacy of the PEG-J tube decompression therapy for the CIPO patients

Scientific Title

Efficacy of the Percutaneus Endoscopic Gastrojejunostomy (PEG-J) tube decompression therapy for patients with chronic intestinal pseudo-obstruction (CIPO)

Scientific Title:Acronym

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

1st name
Middle name
Last name Atsushi Nakajima

Organization

Yokohama City University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

3-9 Fukuura Kanazawa-ku, Yokohama, Japan

TEL

045-787-2640

Email

nakajima-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hidenori Ohkubo

Organization

Yokohama City University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

3-9 Fukuura Kanazawa-ku, Yokohama, Japan

TEL

045-787-2640

Homepage URL


Email

ohkuboh@yokohama-cu.ac.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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)



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 06 Month 01 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

2014 Year 10 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020364


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name