UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluations of autologous fibrin glue and polyglycolic acid sheets as preventing esophageal stricture after endoscopic submucosal dissection of superficial esophageal neoplasms
Title of the study (Brief title)	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	Toshiro Iizuka
Organization	Toranomon Hospital
Division name	Department of Gastroenterology
Address	2-2-2 Toranomon Minato-ku Tokyo
TEL	03-3588-1111
Email	t-iizuka@toranomon.gr.jp

Public contact
Name of contact person	Toshiro Iizuka
Organization	Toranomon Hospital
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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