UMIN-CTR Clinical Trial

Basic information
Public title	Endoscopic ultrasound-guided celiac ganglia neurolysis vs. celiac plexus neurolysis with bilateral technique for cancer pain: a randomized trial
Acronym	Study on comparison of pain relief effect between EUS-CGN and EUS-CPN with bilateral technique
Scientific Title	Endoscopic ultrasound-guided celiac ganglia neurolysis vs. celiac plexus neurolysis with bilateral technique for cancer pain: a randomized trial
Scientific Title:Acronym	Study on comparison of pain relief effect between EUS-CGN and EUS-CPN with bilateral technique
Region	Japan

Condition
Condition	malignant tumor
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess whether the efficacy and safety of EUS-CGN is not inferior to EUS-CPN with bilateral technique for cancer pain
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain relief effect
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	EUS-CGN
Interventions/Control_2	EUS-CPN with bilateral technique
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) A malignant tumor has been diagnosed based on histopathological findings or imaging findings. 2) upper abdominal pain or back pain which the Visual Analogue Scale (VAS) is more than 4. 3) ECOG Performance status (PS) 3 or less. 4) Over 20 years old.
Key exclusion criteria	1) Informed consent cannot be obtained 2) Communication is not possible due to consciousness disorder or mental disorder 3) Abnormal coagulation (PT-INR 1.5 or more) 4) Platelet count less than 50,000 / microL 5) Anticoagulants and antiplatelet agents cannot be discontinued 6) Presence of esophageal and/or gastric varices 7) Presence of abdominal plexus block before 8) Presence of alcohol intolerance 9) The examination responsibility or the attending doctor judged it to be inappropriate for the subject
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Yasuda
Organization	University of Toyama
Division name	Third Department of Internal Medicine
Zip code	930-0194
Address	2630 Sugitani, Toyama city, Toyama prefecture, Japan
TEL	076-434-7301
Email	yasudaich@gmail.com

Public contact
Name of contact person	1st name Nobuhiko Middle name Last name Hayashi
Organization	University of Toyama
Division name	Third Department of Internal Medicine
Zip code	930-0194
Address	2630 Sugitani, Toyama city, Toyama prefecture, Japan
TEL	076-434-7301
Homepage URL
Email	h.nobu.116@gmail.com

Sponsor
Institute	University of Toyama
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center for Clinical Reserch in Toyama University Hospital
Address	2630 Sugitani, Toyama city, Toyama prefecture, Japan
Tel	076-415-8857
Email	rinri@adm.u-toyama.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

Other administrative information
Date of disclosure of the study information	2021 Year 03 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	Preinitiation
Date of protocol fixation	2020 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2024 Year 03 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	2020 Year 10 Month 03 Day
Last modified on	2022 Year 04 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047934