UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018347 |
|---|---|
| Receipt number | R000021238 |
| Scientific Title | Tumor navigation study using ultrasonography and intrathoracoscopic esophagectomy with marking clips |
| Date of disclosure of the study information | 2015/07/18 |
| Last modified on | 2015/07/18 13:08:16 |
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Basic information
Public title
Tumor navigation study using ultrasonography and intrathoracoscopic esophagectomy with marking clips
Acronym
Tumor navigation technique using ultrasonography and marking clips
Scientific Title
Tumor navigation study using ultrasonography and intrathoracoscopic esophagectomy with marking clips
Scientific Title:Acronym
Tumor navigation technique using ultrasonography and marking clips
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
efficacy and safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
diagnostic rate
Key secondary outcomes
safety, time to diagnose
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)the patients underwent marking clips for navigation of lesion
2)no limitation for age, gender, stage, adjuvant therapy
3)stable of general condition and acceptable for this procedure
Key exclusion criteria
the patients that we judged inadequate
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyazaki Tatsuya |
Organization
Gunma University Hospital
Division name
Integrative Center of General Surgery
Zip code
Address
3-39-15 Showa-machi Maebashi-shi Gunma Japan
TEL
027-220-8224
tatsuyamiyazaki@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyazaki Tatsuya |
Organization
Gunma University Hospital
Division name
Integrative center of general surgery
Zip code
Address
3-39-15 Showa-machi Maebashi-shi Gunma Japan
TEL
027-220-8224
Homepage URL
tatsuyamiyazaki@gunma-u.ac.jp
Sponsor or person
Institute
Integrtive center of general surgical science
Institute
Department
Personal name
Funding Source
Organization
Integrtive center of general surgical science
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
| 2015 | Year | 07 | Month | 18 | 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
diagnostic rate 100%
no complication
mean detection time 6.5min
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
| 2014 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The locations of the marking sutures and clips were confirmed in the resected specimens of all patients.
Management information
Registered date
| 2015 | Year | 07 | Month | 18 | Day |
Last modified on
| 2015 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021238
