UMIN-CTR Clinical Trial

Public title

Examination about the usefulness of steroid spraying using a spray tube after esophageal cancer ESD

Acronym

Steroid spraying using a spray tube after esophageal cancer ESD

Scientific Title

Examination about the usefulness of steroid spraying using a spray tube after esophageal cancer ESD

Scientific Title:Acronym

Steroid spraying using a spray tube after esophageal cancer ESD

Region

Japan

Condition

esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of steroid spraying method using a spray tube for post esophageal ESD ulcer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The prevention effect of the stenosis by the spraying method using a spraying tube.
Stenosis is assessed by endoscopic findings, dysphagia score, with or without endoscopic balloon dilation.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Immediately after esophagus ESD, steroids are sprayed using a spray tube (Fine Jet Top). The spray solution is triamcinolone acetonide 40 mg, diluted with saline to a total of 20 ml. Endoscopic follow up after treatment is on the second day, one week, one month, two months after treatment to assess the degree of stenosis, presence or absence of contingencies, and dysphagia score.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who undergo ESD for esophageal cancer and are expected to resect 3/4 or more of the lumen.

Key exclusion criteria

Patients judged to be unsuitable for this study.

Target sample size

25

Name of lead principal investigator

1st name	Atsushi
Middle name
Last name	Goto

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

755-8505

Address

Minami-kogushi 1-1-1, Ube, Yamaguchi

TEL

0836-22-2243

Email

agoto@yamaguchi-u.ac.jp

Name of contact person

1st name	Atsushi
Middle name
Last name	Goto

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

755-8505

Address

Minami-kogushi 1-1-1, Ube, Yamaguchi

TEL

0836-22-2243

Homepage URL

Email

agoto@yamaguchi-u.ac.jp

Institute

Yamaguchi University Graduate School of Medicine, Department of Gastroenterology and Hepatology

Institute

Department

Personal name

Organization

Yamaguchi University Graduate School of Medicine, Department of Gastroenterology and Hepatology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Yamaguchi University Medical School Hospital

Address

Minami-kogushi 1-1-1, Ube, Yamaguchi

Tel

0836-22-2428

Email

me223@yamaguchi-u.ac.jp

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

2019

Year

08

Month

02

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/35898149/

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35898149/

Number of participants that the trial has enrolled

27

Results

Intralesional steroid infusion using a spray tube is a simple and safe technique that is adequately effective in preventing stenosis.

Results date posted

2023

Year

08

Month

05

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

This study included patients who underwent ESD for superficial esophageal cancer at Yamaguchi University Hospital between November 2018 and May 2021 and had a mucosal defect
involving more than three-quarters of the lumen after resection.

Participant flow

When a lesion with a tumor diameter >5 cm was resected in its entire circumference, a combination of steroid injection and
oral steroids was deemed necessary, and the patient was excluded from the study.
Patients who underwent additional surgical resections after ESD were also excluded because of their need for rapid treatment.

Adverse events

Stenosis was identified in five patients (18.5%), and EBD was performed.

Outcome measures

Endoscopic examination was performed before treatment, and follow-up examinations were performed 1 week, 1 month, and 2 months after treatment to test scope passage.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

10

Month

23

Day

Date of IRB

2018

Year

11

Month

28

Day

Anticipated trial start date

2018

Year

11

Month

28

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

08

Month

01

Day

Last modified on

2023

Year

08

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042829