UMIN-CTR Clinical Trial

Basic information
Public title	A validation study of local steroid injection therapy with endoscopic tissue shielding method using polyglycolic sheet and fibrin glue for the prevention of stricture after entire circumferential esophageal endoscopic submucosal dissection (PF-E)
Acronym	A validation study of local steroid injection therapy with endoscopic tissue shielding method using polyglycolic sheet and fibrin glue for the prevention of stricture after entire circumferential esophageal endoscopic submucosal dissection (PF-E)
Scientific Title	A validation study of local steroid injection therapy with endoscopic tissue shielding method using polyglycolic sheet and fibrin glue for the prevention of stricture after entire circumferential esophageal endoscopic submucosal dissection (PF-E)
Scientific Title:Acronym	A validation study of local steroid injection therapy with endoscopic tissue shielding method using polyglycolic sheet and fibrin glue for the prevention of stricture after entire circumferential esophageal endoscopic submucosal dissection (PF-E)
Region	Japan

Condition
Condition	Early stage esophageal cancer after entire circumferential endoscopic submucosal dissection (ESD)
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of local steroid injection therapy with endoscopic tissue shielding method using polyglycolic acid and fibrin glue for the prevention of stricture after entire circumferential esophageal endoscopic submucosal dissection
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of stenosis after ESD
Key secondary outcomes	The number and period of endoscopic dilation, the coverage rate, the time of cover the mucosal defect, PGA sheets residual rate one week later, the number of endoscopic dilation of 12 weeks after ESD, stricture-free survival of 12 weeks after ESD, adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Local sterid (triamcinolone acetonide 100mg) injection and shielding with polyglycolic acid sheets and fibrin glue to the mucosal defect immediately after ESD.
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) Be expected to become entire circumferential mucosal defect after esophageal ESD 2) Over the age of 20 3) Dysphagia score of 0 4) Written informed consent
Key exclusion criteria	1) Active infection requiring systemic therapy 2) Pregnancy, possible pregnancy, within 28 days after delivery or breastfeeding 3) Hypersensitivity for triamcinolone acetone 4) Severe psychiatric disease
Target sample size	11

Research contact person
Name of lead principal investigator	1st name Noboru Middle name Last name Kawata
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
Zip code	411-8777
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777
TEL	055-989-5222
Email	n.kawata@scchr.jp

Public contact
Name of contact person	1st name Noboru Middle name Last name Kawata
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
Zip code	411-8777
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777
TEL	055-989-5222
Homepage URL
Email	n.kawata@scchr.jp

Sponsor
Institute	Shizuoka Cancer Center
Institute
Department

Funding Source
Organization	Shizuoka Cancer Center
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	Shizuoka Cancer Center
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777
Tel	055-989-5222
Email	n.kawata@scchr.jp

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 01 Month 01 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	No longer recruiting
Date of protocol fixation	2016 Year 12 Month 07 Day
Date of IRB	2016 Year 12 Month 07 Day
Anticipated trial start date	2016 Year 12 Month 07 Day
Last follow-up date	2019 Year 11 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 27 Day
Last modified on	2021 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029060