UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007688 |
|---|---|
| Receipt number | R000009068 |
| Scientific Title | The safety and efficacy of a metallic full-coverd stent for preventing stricture after endoscopic submucosal dissection for large esophageal neoplasm |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2013/05/07 14:35:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
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
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
Objectives
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
Assessment
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
Public contact
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
Sponsor or person
Institute
NTT Medical Center Tokyo, Gastroenterology division
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2012 | Year | 08 | 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
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
Other related information
Management 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
