UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Balloon dilatation followed by steroid injection for anastomotic strictures after esophagectomy
Title of the study (Brief title)	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

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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

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	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	noboru hanaoka
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gastrointestinal Oncology
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	noboru hanaoka
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gastrointestinal Oncology
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

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	Non
Organization
Division
Category of Funding Organization	Self funding
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	2011 Year 04 Month 08 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/icdr_e/ctr_view.cgi?recptno=R000006420