UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029419 |
|---|---|
| Receipt number | R000033621 |
| Scientific Title | Study on the Effectiveness of Octreotide Treatment for Chyle Leakage after Neck Dissection |
| Date of disclosure of the study information | 2017/10/04 |
| Last modified on | 2021/10/15 14:42:23 |
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Basic information
Public title
Study on the Effectiveness of Octreotide Treatment for Chyle Leakage after Neck Dissection
Acronym
Study on the Effectiveness of Octreotide Treatment for Chyle Leakage after Neck Dissection
Scientific Title
Study on the Effectiveness of Octreotide Treatment for Chyle Leakage after Neck Dissection
Scientific Title:Acronym
Study on the Effectiveness of Octreotide Treatment for Chyle Leakage after Neck Dissection
Region
| Japan |
Condition
Condition
Choking leak after cervical dissection
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Study on the Effectiveness of Octreotide Treatment for Chyle Leakage after Neck Dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of octreotide
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
| Medicine |
Interventions/Control_1
Octreotide subcutaneous injection
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 whose age is over 20 in consent acquisition
2. Patients with Chyle Leakage after Neck Dissection
3. Patients given written informed consent
Key exclusion criteria
1. Patients with some history of hypersensitivity to Octreotide
2. Patients who are judged inappropriate by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mitsue |
| Middle name | |
| Last name | Yada |
Organization
Osaka General Medical Center
Division name
Department of Oral and Maxillofacial Surgery
Zip code
558-8558
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
mitsue@gh.opho.jp
Public contact
Name of contact person
| 1st name | Mitsue |
| Middle name | |
| Last name | Yada |
Organization
Osaka General Medical Center
Division name
Department of Oral and Maxillofacial Surgery
Zip code
558-8558
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
Homepage URL
mitsue@gh.opho.jp
Sponsor or person
Institute
Osaka General Medical Center
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
Medical Center Clinical Research Review Board
Address
3-1-56 bandai-higashi sumiyoshi-ku Osaka, Osaka
Tel
06-6692-1201
kenkyu-crb@gh.opho.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 | 10 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
2
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
| 2017 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 04 | Day |
Last modified on
| 2021 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033621
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
