UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047454 |
|---|---|
| Receipt number | R000054113 |
| Scientific Title | Prospective observational study investigating the safety and efficacy of airway stent for tracheoesophageal and bronchial esophageal fistula |
| Date of disclosure of the study information | 2022/04/11 |
| Last modified on | 2022/04/12 22:56:39 |
* 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
Prospective observational study investigating the safety and efficacy of airway stent for tracheoesophageal and bronchial esophageal fistula
Acronym
Safety and efficacy of airway stent for tracheoesophageal fistula
Scientific Title
Prospective observational study investigating the safety and efficacy of airway stent for tracheoesophageal and bronchial esophageal fistula
Scientific Title:Acronym
Safety and efficacy of airway stent for tracheoesophageal fistula
Region
| Japan |
Condition
Condition
Tracheoesophageal and bronchial esophageal fistula
Classification by specialty
| Medicine in general | Gastroenterology | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of airway stent for tracheoesophageal and bronchial esophageal fistula
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate whether the patients can eat solid food at 30 days after airway stenting
Key secondary outcomes
1.To check whether fistula is still persistent after airway stenting
2.To evaluate the safety of the procedure (e.g. pneumonia, bleeding, deviation and so on)
3.To evaluate the visual analog scale (VAS) of symptoms
4.If it complicated pneumonia before stenting, it will be improved or not
5.The survival time after airway stenting
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)Patients with fistula between the central airway and esophagus who are expected to show symptom improvement
2)Patients who are expected to restart eating after airway stenting
3)Patients who are expected to survive for more than one month
4)20 years or older
5)Informed consent
Key exclusion criteria
1)It is difficult to start eating because of esophageal obstruction or consciousness disorder, etc.
2)Patients with difficulty eating because of performance status
3)Patients who have difficulty answering VAS
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Torii |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
460-0001
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL
052-951-1111
a51009068@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Torii |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
460-0001
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL
052-951-1111
Homepage URL
a51009068@gmail.com
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Nagoya Medical 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
the Institutional Review Board of Nagoya Medical Center
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
Tel
052-951-1111
311-rec@mail.hosp.go.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
| 2022 | Year | 04 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective consecutive study
Management information
Registered date
| 2022 | Year | 04 | Month | 10 | Day |
Last modified on
| 2022 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054113
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
