UMIN-CTR Clinical Trial

Public title

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

Acronym

Kenacort injection or application for the esophagus

Scientific Title

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

Scientific Title:Acronym

Kenacort injection or application for the esophagus

Region

Japan

Condition

Early esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hirohito Mori

Organization

Kagawa University

Division name

Department of gastroenterology

Zip code

Address

1750-1 ooaza ikenobe miki town kida county kagawa prefecture

TEL

087-891-2156

Email

hiro4884@med.kagawa-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shintaro Fujhara

Organization

Kagawa University

Division name

Department of gastroenterology

Zip code

Address

1750-1 ooaza ikenobe miki town kida county kagawa prefecture

TEL

087-891-2156

Homepage URL

Email

joshin@med.kagawa-u.ac.jp

Institute

Kagawa University

Institute

Department

Personal name

Organization

Kagawa University

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

06

Month

15

Day

URL releasing protocol

Publication of results

Partially published

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

Recruitment status

Completed

Date of protocol fixation

2009

Year

05

Month

15

Day

Date of IRB

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

Other related information

The study (UMIN000005546,3743) was reregistered and was discontinued.
This study was original version.

Registered date

2010

Year

06

Month

15

Day

Last modified on

2016

Year

08

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004556