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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002536
Receipt No. 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

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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
Email

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
Email YASUDAIC@aol.com

Sponsor
Institute EUS-CPN/CGN study group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003098

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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