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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027336
Receipt No. R000031324
Scientific Title Clinical evaluations of autologous fibrin glue and polyglycolic acid sheets as preventing esophageal stricture after endoscopic submucosal dissection of superficial esophageal neoplasms
Date of disclosure of the study information 2017/05/15
Last modified on 2017/05/14

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Basic information
Public title Clinical evaluations of autologous fibrin glue and polyglycolic acid sheets as preventing esophageal stricture after endoscopic submucosal dissection of superficial esophageal neoplasms
Acronym The efficacy of shielding method with autologous fibrin glue and polyglycolic acid sheets for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection
Scientific Title Clinical evaluations of autologous fibrin glue and polyglycolic acid sheets as preventing esophageal stricture after endoscopic submucosal dissection of superficial esophageal neoplasms
Scientific Title:Acronym The efficacy of shielding method with autologous fibrin glue and polyglycolic acid sheets for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection
Region
Japan

Condition
Condition superficial esophageal neoplasms
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the safety and efficacy of shielding method with autologous fibrin glue and polyglycolic acid sheets after esophageal endoscopic submucosal dissection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of postoperative esophageal stricture (within 26 weeks after ESD)
Key secondary outcomes The number of sessions of endoscopic balloon dilatation required to resolve any strictures, and the interval between ESD and developing the regenerating epithelium.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver Other
Interventions/Control_1 shielding with autologous fibrin glue and polyglycolic acid sheets
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. The patient must be greater than 20 years old.
2. Superficial esophageal squamous cell carcinoma or high grade intraepithelial neoplasia is diagnosed pathologically.
3. The patient is supposed to undergo ESD in our institute.
4. The mucosal defect is supposed to be more than the half circumference of esophagus.
Key exclusion criteria 1. The mucosal defect is supposed to be entire circumference of esophagus.
2. The lesion is supposed to be SM or deeper.
3. The level of Hb is under 11.
4. The performance is poor and it is difficult to undergo ESD.
5. Severe cardiac disease (Aortic stenosis, etc)
6. The patient has a history of fever, diarrhea, or dental extraction within 72 hours.
7. Others
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiro Iizuka
Organization Toranomon Hospital
Division name Department of Gastroenterology
Zip code
Address 2-2-2 Toranomon Minato-ku Tokyo
TEL 03-3588-1111
Email t-iizuka@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiro Iizuka
Organization Toranomon Hospital
Division name Department of Gastroenterology
Zip code
Address 2-2-2 Toranomon Minato-ku Tokyo
TEL 03-3588-1111
Homepage URL
Email t-iizuka@toranomon.gr.jp

Sponsor
Institute Toranomon Hospital
Institute
Department

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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 15 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 Preinitiation
Date of protocol fixation
2017 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 15 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
2017 Year 05 Month 14 Day
Last modified on
2017 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031324

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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