UMIN-CTR Clinical Trial

Basic information
Public title	Clinical efficacy of triamcinolone acetonide-filling method for the prevention of esophageal stenosis after subcircumferential or circumferential ESD (multicenter phase II study)
Acronym	esophageal triamcinolone acetonide-filling method
Scientific Title	Clinical efficacy of triamcinolone acetonide-filling method for the prevention of esophageal stenosis after subcircumferential or circumferential ESD (multicenter phase II study)
Scientific Title:Acronym	esophageal triamcinolone acetonide-filling method
Region	Japan

Condition
Condition	superficial esophageal carcinoma requiring 3/4 round or more resection by ESD
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To estimate the efficacy and safety of the esophageal triamcinolone acetonide (TA)-filling method in the prevention of esophageal stenosis after subcircumferential and circumferential ESD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence rate of severe stenosis
Key secondary outcomes	A total number of Endoscopic balloon dilatation (EBD) and additional TA-filling procedure, dysphagia score, complete re-epithelialization time without stenosis, and other 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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	no control (single arm)
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)Endoscopically diagnosed as the superficial esophageal cancer with a half of circumference or more . 2)Neither lymph nor distant metastasis was recognized by X-ray, abdominal ultrasonography, endoscopic ultrasonography, and computed tomography. 3)Post-ESD ulcer is expected to reach three quater or more. 4)Prognosis is expected to be improved by endoscopic resection of the lesion. 5)General status is expected to be tolerant of general or intravenouos anesthesia. 6)Patient agree with the participation in the study.
Key exclusion criteria	1)severe infection of pharyngolarynx or esophagus. 2)high risk of drug aspiration due to the vocal code paralysis or dysphagea.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kotaro Shibagaki
Organization	Shimane University Hospital
Division name	Gastroenterology
Zip code
Address	89-1 Enya, Izumo, Japan
TEL	+81-85320-2190
Email	kotaro@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kotaro Shibagaki
Organization	Shimane University Hospital
Division name	Gastroenterology
Zip code
Address	89-1 Enya, Izumo, Japan
TEL	+81-85320-2190
Homepage URL
Email	kotaro@med.shimane-u.ac.jp

Sponsor
Institute	Gastroenterology, Faculty of Medicine, Shimane University
Institute
Department

Funding Source
Organization	No fund.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2016 Year 11 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	Open public recruiting
Date of protocol fixation	2016 Year 09 Month 30 Day
Date of IRB	2016 Year 09 Month 26 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2017 Year 11 Month 20 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 10 Month 12 Day
Last modified on	2020 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028066