UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004249
Receipt number R000005103
Scientific Title The feasibility of a metalic stent for Esophageal benign stricture after endoscopic submucosal dissection for esophageal squamous cell neoplasms
Date of disclosure of the study information 2010/09/22
Last modified on 2013/03/24 09:37:50

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Basic information

Public title

The feasibility of a metalic stent for Esophageal benign stricture after endoscopic submucosal dissection for esophageal squamous cell neoplasms

Acronym

Metalic stent for esophageal benign stricture

Scientific Title

The feasibility of a metalic stent for Esophageal benign stricture after endoscopic submucosal dissection for esophageal squamous cell neoplasms

Scientific Title:Acronym

Metalic stent for esophageal benign stricture

Region

Japan


Condition

Condition

superficial esophageal squamous cell neoplasms

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the feasibility of the metalic stent placement, followed by stent removal after a period, for esophageal benign stricture after endoscopic submucosal dissection for superficial esophageal squamous cell neoplasms.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Incidence of the complication related with metalic stent placement.

Key secondary outcomes

1) Incidence of the re-stricture after stent removal
2) Duration of stricture-free or symptom-free period


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Place a metalic stent for esophageal benign stricture.

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1. age; 20-80 years-old
2. with esophageal benign stricture after endoscopic submucosal dissection for esophageal squamous cell neoplasms.
3. with re-stricture after endoscopic balloon dilation for esophageal benign stricture.
4. Performance status: 0, 1.
5. with or without multiple stricture.
6. without organ failure.
7. without serious complication.
8. obtained written informed consent.

Key exclusion criteria

1. post operative status of esophagectomy.
2. with overt infection or inflammation of esophagus.
3. inappropriate for this study.

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirohisa Machida

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Gastroenterology

Zip code


Address

1-4-3, Asahi-machi, Abeno, Osaka, Japan

TEL

06-6645-3811

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hirohisa Machida

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Gastroenterology

Zip code


Address

1-4-3, Asahi-machi, Abeno, Osaka, Japan

TEL

06-6645-3811

Homepage URL


Email



Sponsor or person

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Osaka City University Graduate School of Medicine

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

2010 Year 09 Month 22 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

Terminated

Date of protocol fixation

2010 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 09 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

2010 Year 09 Month 22 Day

Last modified on

2013 Year 03 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005103


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name