UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025447
Receipt number R000029060
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)
Date of disclosure of the study information 2017/01/01
Last modified on 2021/07/01 17:03:19

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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 or person

Institute

Shizuoka Cancer Center

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029060


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name