UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of local steroid injection or application on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early-stage esophageal cancer - Preventing esophageal stenosis due to scar formation during the epithelial regeneration process
Title of the study (Brief title)	Kenacort injection or application for the esophagus
Region	Japan

Condition
Condition	Early esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Local steroid injection or application therapy is effective for preventing esophageal stricture after endoscopic submucosal dissection (ESD). We evaluated the effectiveness of triamcinolone acetonide (TA) application followed by balloon dilatation compared to steroid injection and application following endoscopic submucosal dissection for esophageal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome measure was the difference in stricture rate between groups determined by gastrografin esophagograms on PODs 5, 8, 12, 15, 20, 30, and 60 between 2 gouups.
Key secondary outcomes	The number of EBD procedures, the number of procedure-related bleeding events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment Maneuver
Interventions/Control_1	In the local steroid injection group, 0.2 ml (2 mg) TA was locally injected into the ulcer floor at 8 mm intervals with extra care to avoid injection and following 5 min balloon dilatation (12-15 mm in diameter) was performed on PODs 5, 8, 12, and 15. Gastrografin esophagograms was also taken on PODs 5, 8, 12, 15, 20, 30, and 60. The 45-degree RAO position to evaluate esophageal stricture.
Interventions/Control_2	In the steroid gel application group on each PODs 5, 8, 12, and 15 triamcinolone acetonide (TA) gel was locally applied onto the ulcer floor and following balloon dilatation was performed immediately. The TA gel was made and applied as follows: total of 10 ml TA (100 mg) was mixed with 7.5 ml Endolubri jelly to make 17.5 ml of gel
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	30 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with early-stage esophageal cancer who had undergone endoscopic submucosal dissection with an excision of three fourths to the full circumference of the esophagus from whom informed consent was obtained
Key exclusion criteria	nothing in particular
Target sample size	45

Research contact person
Name of lead principal investigator	Hirohito Mori
Organization	Kagawa University
Division name	Department of gastroenterology
Address	1750-1 ooaza ikenobe miki town kida county kagawa prefecture
TEL	087-891-2156
Email	hiro4884@med.kagawa-u.ac.jp

Public contact
Name of contact person	Shintaro Fujhara
Organization	Kagawa University
Division name	Department of gastroenterology
Address	1750-1 ooaza ikenobe miki town kida county kagawa prefecture
TEL	087-891-2156
Homepage URL
Email	joshin@med.kagawa-u.ac.jp

Sponsor
Institute	Kagawa University
Institute
Department

Funding Source
Organization	Kagawa University
Organization
Division
Category of Funding Organization
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	2010 Year 06 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 05 Month 15 Day
Anticipated trial start date	2009 Year 06 Month 01 Day
Last follow-up date	2016 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	The study (UMIN000005546,3743) was reregistered and was discontinued. This study was original version.

Management information
Registered date	2010 Year 06 Month 15 Day
Last modified on	2016 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004556