UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002558 |
|---|---|
| Receipt number | R000003127 |
| Scientific Title | Clinical trial of ethanolamine oleate sclerotherapy for hemangioma in the oral and maxillofacial region |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2020/04/21 21:31:19 |
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Basic information
Public title
Clinical trial of ethanolamine oleate sclerotherapy for hemangioma in the oral and maxillofacial region
Acronym
Clinical trial of ethanolamine oleate sclerotherapy for hemangioma
Scientific Title
Clinical trial of ethanolamine oleate sclerotherapy for hemangioma in the oral and maxillofacial region
Scientific Title:Acronym
Clinical trial of ethanolamine oleate sclerotherapy for hemangioma
Region
| Japan |
Condition
Condition
low flow hemangioma of oral and maxillofacial region
Classification by specialty
| Radiology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of ethanolamine oleate sclerotherapy for low flow hemangioma in the oral and maxillofacial region
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of tumor size in clinical findings or MRI remarks.
Recurrence rate at 1 year after treatment
Key secondary outcomes
Incidences of complications or side effects
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 | Maneuver |
Interventions/Control_1
We measure the blood flow in the tumor with CT using contrast medium.
If the tumor ia low flow, we inject 5% ethanolamine oleate and watch for 5 minutes. After that, we collect the sclerosing agent.
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
Patient who has low flow hemangioma
Patient who accept the participation in this trial
Key exclusion criteria
Patient who has kidney trouble (24h CCr<= 70L/day)
Patient who is unsuitable to this trial
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yosiho |
| Middle name | |
| Last name | Yamashita |
Organization
Saga University Hospital
Division name
Oral and maxillofacial Surgery
Zip code
849-8501
Address
5-1-1, Nabeshima, Saga, Japan
TEL
0952-34-2397
Yamashy2@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Danjo |
Organization
Saga University Hospital
Division name
Oral and maxillofacial Surgery
Zip code
849-8501
Address
5-1-1, Nabeshima, Saga, Japan
TEL
0952-34-2397
Homepage URL
danjoat@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Hospital
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
Radiology, Saga University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research center, Saga University Hospital
Address
5-1-1, Nabeshima, Saga, Japan
Tel
0952343357
kenkyu-shinsei@ml.cc.saga-u.ac.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
佐賀大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/latest-detail/jRCTs071180067
Publication of results
Unpublished
Result
URL related to results and publications
https://jrct.niph.go.jp/latest-detail/jRCTs071180067
Number of participants that the trial has enrolled
9
Results
The lesion was reduced in all caseses. Threre were no peri-operative adverse events that met the discontinuation criteria. The adverse events included postoperative pain and swelling thich could be dealt with by observing and taking painkillers. THere was one case od recurrence of lesion, and no obvious recurrence of lesion was observed after retreatment.
Results date posted
| 2020 | Year | 04 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with venous malformations in the oral and maxillofacial region who have a tumor with low flow diagnosed on MRI. Regardless of age or sex, the patient was the one who gave the informed consent directly. Also, patients with low renal function with estimated creatinine clrearance of <60 ml/min were excluded.
Participant flow
After consenting to this study, it will be confirmed by MRI and blood exam that the indication criteria are met. Perform procedures in the angiography room with IVR specialists. After local anesthesia, puncture, angiography and CT under angiography measure the distribution of blood vessels and flow. Block the blood flow and inject a hardening agents. After 5minutes, collect the curing agent as much as possible. Angiography was performed agein, and it was confirmed that the blood flow had disappeared, hemostatis was confirmed, and the procedure was completed. Follow-up observation after procedure and determination of therapeutic effect by MRI 3 months later.
Adverse events
Post-operative pain, swelling, fever, local erosion, ulceration
Outcome measures
Therapeutic effect, adverse event rate, recurrence rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2009 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2009 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | 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
| 2009 | Year | 09 | Month | 28 | Day |
Last modified on
| 2020 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003127
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