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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000010251
Receipt No. 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

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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
Email 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
Email kanetaka@nagasaki-u.ac.jp

Sponsor
Institute Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

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
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
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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011998

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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