UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010251 |
|---|---|
| Receipt number | R000011998 |
| Scientific Title | Safety and efficacy of transplantation of tissue-engineered autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2018/09/18 16:57:34 |
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Basic information
Public title
Safety and efficacy of transplantation of tissue-engineered autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer
Acronym
Safety and efficacy of transplantation of oral mucosal epithelial cell sheets in preventing formation of strictures after ESD
Scientific Title
Safety and efficacy of transplantation of tissue-engineered autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer
Scientific Title:Acronym
Safety and efficacy of transplantation of oral mucosal epithelial cell sheets in preventing formation of strictures after ESD
Region
| Japan |
Condition
Condition
superficial esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the safety and efficacy of transplantation of tissue-engineered autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intra and post-operative morbidity, stricture, dysphagia score
Key secondary outcomes
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
| Maneuver | Other |
Interventions/Control_1
We transplant tissue-engineered autologous oral mucosal epithelial cell sheets to ulcer surface after endoscopic submucosal dissection for esophageal cancer
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with large esophageal cancer expected to result in a post-ESD artificial ulcer of a size of not less than two-thirds of the circumference
Key exclusion criteria
Exclusion criteria includes severe diabetes mellitus, heart disease, renal desease, active double cancers, undergoing treatment for oral, laryngeal, pharyngeal cancers, receiving radiotherapy for early esophageal cancer
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Eguchi |
Organization
Nagasaki University Hospital
Division name
Department of Surgery
Zip code
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
+81958197316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Kanetaka |
Organization
Nagasaki University Hospital
Division name
Department of Surgery
Zip code
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7316
Homepage URL
kanetaka@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University
Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University
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
| 2013 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
| 2013 | Year | 03 | Month | 15 | Day |
Last modified on
| 2018 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011998
