UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002536 |
|---|---|
| Receipt number | R000003098 |
| Scientific Title | Endoscopic Ultrasound-guided Celiac Plexus Neurolysis vs Direct Celiac Ganglia Neurolysis for upper abdominal cancer pain: A randomized multicenter phase-II trial |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2012/03/24 10:32:53 |
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Basic information
Public title
Endoscopic Ultrasound-guided Celiac Plexus Neurolysis vs Direct Celiac Ganglia Neurolysis for upper abdominal cancer pain: A randomized multicenter phase-II trial
Acronym
EUS-CPN vs EUS-CGN for cancer pain
Scientific Title
Endoscopic Ultrasound-guided Celiac Plexus Neurolysis vs Direct Celiac Ganglia Neurolysis for upper abdominal cancer pain: A randomized multicenter phase-II trial
Scientific Title:Acronym
EUS-CPN vs EUS-CGN for cancer pain
Region
| Japan |
Condition
Condition
Upper abdominal cancer pain
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of EUS-CGN for cancer pain in comparison to EUS-CPN
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
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, procedure period, and incidence of complications.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
EUS-CPN
Interventions/Control_2
EUS-CGN
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
Inclusion criteria:
1. Patients with upper abdominal malignancy whose diagnosis was confirmed by pathological or imaging results.
2. Patients with upper abdominal or back pain of grade-4 or more visual analog scale (VAS) score.
3. Patients with relatively good performance status, ECOG PS 3 or less.
Key exclusion criteria
1) Patients whose informed consent could not be obtained.
2) Patients with lack of communication ability.
3) PT-INR: >= 1.5.
4) Platelet count: <=50,000/mm2.
5) Regularly user of anti-coagulants, and in case that the administration cannot be suspended.
6) Patients with esophageal or cardia varices.
7) Patients with severe alcohol intolerance.
8) In case that doctors judged inappropriate for the entry to this study.
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
Address
1-1, Yanagido, Gifu 501-1194, Japan
TEL
058-230-6308
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
Address
1-1, Yanagido, Gifu 501-1194, Japan
TEL
058-230-6308
Homepage URL
YASUDAIC@aol.com
Sponsor or person
Institute
EUS-CPN/CGN study group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
岐阜大学医学部附属病院消化器内科(岐阜県),岐阜市民病院消化器内科(岐阜県),岐阜県総合医療センター消化器科(岐阜県),愛知県がんセンター消化器内科(愛知県),福島県立医科大学消化器内科(福島県),手稲渓仁会病院消化器病センター(北海道),山口大学医学部附属病院消化器病態内科学(山口県),JA広島厚生連尾道総合病院内視鏡センター(広島県),伊達赤十字病院消化器科(北海道),北海道大学病院消化器内科(北海道),札幌医科大学附属病院第四内科(北海道),近畿大学消化器内科(大阪府),東京医科大学第四内科(東京都),北里大学医学部附属病院消化器内科(神奈川県),横浜市立大学消化器内科(神奈川県),大阪市立大学消化器内科(大阪府)
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 21 | Day |
Last modified on
| 2012 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003098
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
