UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Susumu Eguchi
Organization	Nagasaki University Hospital
Division name	Department of Surgery
Address	1-7-1 Sakamoto, Nagasaki, Japan
TEL	+81958197316
Email	sueguchi@nagasaki-u.ac.jp

Public contact
Name of contact person	Kengo Kanetaka
Organization	Nagasaki University Hospital
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011998