UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005411
Receipt No. R000006420
Scientific Title Balloon dilatation followed by steroid injection for anastomotic strictures after esophagectomy
Date of disclosure of the study information 2011/04/08
Last modified on 2016/04/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Balloon dilatation followed by steroid injection for anastomotic strictures after esophagectomy
Acronym BD followed by steroid
Scientific Title Balloon dilatation followed by steroid injection for anastomotic strictures after esophagectomy
Scientific Title:Acronym BD followed by steroid
Region
Japan

Condition
Condition patients with anastomotic strictures after esophagectomy
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determin whether balloon dilatation followed by steroid injection for anastomotic strictures is effective or not.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A frequency of balloon dilatation for anastomotic strictures
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 steroid injection
Interventions/Control_2 physiologic saline injection
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients without a history of balloon dilatation for anastomotic stricture.
2. Patients underwent gastric tube reconstruction.
3. Patients underwent retrosternal or posterior mediastinum reconstruction.
4. Patients without multiple organ failure.
5. Patients with informed concent.
Key exclusion criteria 1. Patients undergoing anticoagulant therapy
2. Patients with agressive tumor
3. Patients with severe diabetes.
4. Inappropriate for this trial.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name noboru hanaoka
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 1-3-3, Nakamichi Higashinariku, Osaka, Japan
TEL 06-6972-1181
Email hanaoka-no@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name noboru hanaoka
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 1-3-3, Nakamichi Higashinariku, Osaka, Japan
TEL 06-6972-1181
Homepage URL
Email hanaoka-no@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization Non
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 04 Month 08 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 Enrolling by invitation
Date of protocol fixation
2011 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 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
2011 Year 04 Month 08 Day
Last modified on
2016 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006420

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.