UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006327
Receipt number R000007494
Scientific Title A randomized clinical trial for the efficacy and safety of local steroid injection for prevention of post-ESD esophageal stenosis
Date of disclosure of the study information 2011/09/15
Last modified on 2016/03/16 11:13:48

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Basic information

Public title

A randomized clinical trial for the efficacy and safety of local steroid injection for prevention of post-ESD esophageal stenosis

Acronym

A RCT of local steroid injection for prevention of post-ESD esophageal stenosis

Scientific Title

A randomized clinical trial for the efficacy and safety of local steroid injection for prevention of post-ESD esophageal stenosis

Scientific Title:Acronym

A RCT of local steroid injection for prevention of post-ESD esophageal stenosis

Region

Japan


Condition

Condition

Early esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy and safety of local steroid injection for prevention of post-ESD esophageal stenosis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

The proportion of patients who need endoscopic dilatation for post-ESD esophageal stenosis

Key secondary outcomes

1. The frequency of the complication with local steroid injection
2. The frequency of the complication with endoscopic dilatation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Local steroid injection (Triamcinolone Acetonide) after ESD

Interventions/Control_2

No treatment after ESD

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

Patients with superficial squamous cell carcinoma whose mucosal defect after ESD is expected to be over three-fourths of the whole circumference (being highly associated with post ESD stenosis)

Key exclusion criteria

Excluded if patients have:
1. previous therapy experience
2. steroid treatment for other diseases
3. esophageal adenocarcinoma
4. swallowing difficulty

Target sample size

32


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Takahashi

Organization

Keiyukai Sapporo Hospital

Division name

Dept. of Gastroenterology

Zip code


Address

1-1, Hondori 14 north, Shiroishi-ku, Sapporo, Hokkaido, Japan

TEL

011-863-2101

Email

hiroaki@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Takahashi

Organization

Keiyukai Sapporo Hospital

Division name

Dept. of Gastroenterology

Zip code


Address

1-1, Hondori 14 north, Shiroishi-ku, Sapporo, Hokkaido, Japan

TEL

011-863-2101

Homepage URL


Email

hiroaki@sapmed.ac.jp


Sponsor or person

Institute

Dept. of Gastroenterology, Keiyukai Sapporo 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


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

恵佑会札幌病院(北海道)


Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 15 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/25609176

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

2010 Year 01 Month 07 Day

Date of IRB


Anticipated trial start date

2010 Year 02 Month 01 Day

Last follow-up date

2011 Year 10 Month 01 Day

Date of closure to data entry

2011 Year 10 Month 01 Day

Date trial data considered complete

2011 Year 10 Month 01 Day

Date analysis concluded

2012 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 09 Month 12 Day

Last modified on

2016 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007494


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name