UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001684
Receipt number R000002012
Scientific Title A Randomized Controlled Trial of the Usefulness of Double Balloon Enteroscopy and Single Balloon Enteroscopy for Difficult Cases of Colonoscope Insertion
Date of disclosure of the study information 2009/02/02
Last modified on 2010/11/24 22:40:02

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Basic information

Public title

A Randomized Controlled Trial of the Usefulness of Double Balloon Enteroscopy and Single Balloon Enteroscopy for Difficult Cases of Colonoscope Insertion

Acronym

RCT of DBE vs. SBE for difficult colonoscope insertion

Scientific Title

A Randomized Controlled Trial of the Usefulness of Double Balloon Enteroscopy and Single Balloon Enteroscopy for Difficult Cases of Colonoscope Insertion

Scientific Title:Acronym

RCT of DBE vs. SBE for difficult colonoscope insertion

Region

Japan


Condition

Condition

Colon disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To estimate efficacy and safety on balloon enteroscopy using double balloon enteroscopy or single balloon enteroscopy for completion of colon examination after incomplete colonoscopy with conventional colonoscope

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Total colonoscopy rate
Examination time
Manual compression rate
Changing position rate
X-ray exposure time
Diagnostic yield

Key secondary outcomes

Patient's pain on examination,
Operability of endoscopy
Complication


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Double balloon enteroscopy

Interventions/Control_2

Single balloon enteroscopy

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who had incomplete colonoscopy with a conventional colonoscope

Key exclusion criteria

Patients with known fulminant colitis or colorectal malignancy
Incomplete colonoscopy because of fixed stenosis or poor bowel preparation
Severe hepatic dysfunction or severe renal dysfunction

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yutaka Yamaji

Organization

The University of Tokyo

Division name

Department of Gastroenterology

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yutaka Yamaji

Organization

The University of Tokyo

Division name

Department of Gastroenterology

Zip code


Address

7-3-1, Hongo, Bunkyo-ku,Tokyo, Japan

TEL

03-3815-5411

Homepage URL


Email

yamaji-tky@umin.ac.jp


Sponsor or person

Institute

Department of Gastroenterology, The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

2009 Year 02 Month 02 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

2008 Year 07 Month 03 Day

Date of IRB


Anticipated trial start date

2008 Year 08 Month 01 Day

Last follow-up date

2009 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 02 Month 02 Day

Last modified on

2010 Year 11 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002012


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name