UMIN-CTR Clinical Trial

Public title

The safety and efficacy of a metallic full-coverd stent for preventing stricture after endoscopic submucosal dissection for large esophageal neoplasm

Acronym

The safety and efficacy of a metallic full-coverd stent for preventing stricture after endoscopic submucosal dissection for large esophageal neoplasm

Scientific Title

The safety and efficacy of a metallic full-coverd stent for preventing stricture after endoscopic submucosal dissection for large esophageal neoplasm

Scientific Title:Acronym

The safety and efficacy of a metallic full-coverd stent for preventing stricture after endoscopic submucosal dissection for large esophageal neoplasm

Region

Japan

Condition

Superficial esophageal neoplasm which needs semicircumferential (more than three fourths of the circumference of the esophageal lumen) or circumferential ESD

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We will evaluate the safety and efficacy of a removable metallic full-coverer stent placement for preventing stricture after esophageal semicircumferential (more than three fourths of the circumference of the esophageal lumen) or circumferential ESD

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

The safety (the incidence of severe complications)
The efficacy (the number of required endoscopic balloon dilatation within three months after stent removal)

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

Device,equipment

Interventions/Control_1

We will place a metallic full-covered stent for the patient with a mucosal defect more than three fourths of the circumference by esophageal ESD. The stent placement will be performed under both direct visualization with an endoscope and radiographic guidance. We will remove the stent 10 days after placement and check the patient's condition regularly.

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

1. The depth of neoplasm is predicted to be intramucosal or submucosal invasion less than 200 um.
2. The mucosal defect due to ESD is predicted to be three fourths of the circumference.
3. The function of key organs is within normal limits.
4. Those who submit written informed consent.

Key exclusion criteria

1. The case where micro perforation occurs during ESD.
2. The case where the proximal side of the stent may reach pharynx.
3. Those who are suffering from severe diabetes mellitus.
4. Those who received radiation to their esophagus.
5. Those who have psychiatric disease and predicted to have difficulty in participating in this study.
In addition, those who are judged to be inappropriate by doctors.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Yosuke Tsuji

Organization

NTT Medical Center Tokyo

Division name

Gastroenterology division

Zip code

Address

5-9-22, Higashi-Gotanda, Shinagawa-ku

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

NTT Medical Center Tokyo

Division name

Gastroenterology division

Zip code

Address

TEL

Homepage URL

Email

Institute

NTT Medical Center Tokyo, Gastroenterology division

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2012

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

2011

Year

12

Month

18

Day

Date of IRB

Anticipated trial start date

2012

Year

04

Month

01

Day

Last follow-up date

2013

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

04

Month

08

Day

Last modified on

2013

Year

05

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009068