UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027336 |
|---|---|
| Receipt number | 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 16:58:25 |
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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
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
t-iizuka@toranomon.gr.jp
Sponsor or person
Institute
Toranomon 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031324
