UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008129 |
|---|---|
| Receipt number | R000009559 |
| Scientific Title | Endoscopic Ultrasound-Celiac plexus neurolysis for Cancer pain in alcohol intolerance patient; Retrospective analysis of the utility of endoscopic ulatrasound-guided celiac plexus neurolysis using phenol. |
| Date of disclosure of the study information | 2012/06/18 |
| Last modified on | 2014/09/09 16:18:25 |
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Basic information
Public title
Endoscopic Ultrasound-Celiac plexus neurolysis for Cancer pain in alcohol intolerance patient; Retrospective analysis of the utility of endoscopic ulatrasound-guided celiac plexus neurolysis using phenol.
Acronym
A feasibility study of EUS-CPN using phenol.
Scientific Title
Endoscopic Ultrasound-Celiac plexus neurolysis for Cancer pain in alcohol intolerance patient; Retrospective analysis of the utility of endoscopic ulatrasound-guided celiac plexus neurolysis using phenol.
Scientific Title:Acronym
A feasibility study of EUS-CPN using phenol.
Region
| Japan |
Condition
Condition
Patients who underwent EUS-CPN for cancer pain.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and safety of EUS-CPN using phenol by comparing to EUS-CPN using ethanol.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain relief effect at 7 days after the treatment (ratio of effective cases)
Key secondary outcomes
Ratio of complete pain relief cases at 7 days after the treatment, Difference of VAS between before and 7 days after the treatment, duration of pain relief effect and incidence of complications.
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
Patients who underwent EUS-CPN.
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Ishiwatari |
Organization
Sapporo Medical University
Division name
4th department of Internal Medicine
Zip code
Address
Minami 1-jo, ishi 16-chome, Chuoku, Sapporo
TEL
011-611-2111
ishihiro@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Ishiwatari |
Organization
Sapporo Medical University
Division name
4th department of Internal Medicine
Zip code
Address
South-1, West-16, Chuoku, Sapporo
TEL
011-611-2111
Homepage URL
ishihiro@sapmed.ac.jp
Sponsor or person
Institute
4th department of Internal Medicine, Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
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 | 06 | Month | 18 | 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
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
Main results already published
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study
Management information
Registered date
| 2012 | Year | 06 | Month | 09 | Day |
Last modified on
| 2014 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009559
