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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027203
Receipt No. R000031154
Scientific Title Efficacy and Safety of Endoscopic Ultrasound Guided Central versus Bilateral Celiac Plexus Neurolysis for Managing Abdominal Pain Associated with Pancreatic Cancer
Date of disclosure of the study information 2019/04/01
Last modified on 2017/05/01

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Basic information
Public title Efficacy and Safety of Endoscopic Ultrasound Guided Central versus Bilateral Celiac Plexus Neurolysis for Managing Abdominal Pain Associated with Pancreatic Cancer
Acronym Endoscopic Ultrasound Guided Central versus Bilateral Celiac Plexus Neurolysis for Managing Abdominal Pain Associated with Pancreatic Cancer
Scientific Title Efficacy and Safety of Endoscopic Ultrasound Guided Central versus Bilateral Celiac Plexus Neurolysis for Managing Abdominal Pain Associated with Pancreatic Cancer
Scientific Title:Acronym Endoscopic Ultrasound Guided Central versus Bilateral Celiac Plexus Neurolysis for Managing Abdominal Pain Associated with Pancreatic Cancer
Region
Africa

Condition
Condition is EUS Guided Safe and effective in managing pancreatic cancer pain and with method is better ( Central VS Bilateral
and what is the best time for intervention early or late salvage therapy ?
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 aim of this study is to compare central endoscopic ultrasound guided
versus bilateral celiac plexus neurolysis using absolute alcohol for pain control with pancreatic cancer
Basic objectives2 Others
Basic objectives -Others the optimal time for intervention early vs late salvage therapy
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes central endoscopic ultrasound guided
versus bilateral celiac plexus neurolysis using absolute alcohol for pain control with pancreatic cancer which is better ?
by assessing pain duration before the procedure, the
dose and type of analgesic used, and visual analog scale pain score pre and
post-treatment at day 7th , 14th and after two months.
Key secondary outcomes The best Time of intervention early or salvage therapy
Decreased requirement for analgesics

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 First group
- central Endoscopic Ultrasound guided celiac nerve neurolysis in managing pain in patient
with pancreatic cancer
Interventions/Control_2 second group
- bilateral Endoscopic Ultrasound guided celiac nerve neurolysis in managing pain in patient
with pancreatic cancer
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
18 years-old <
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria - age older than 18 years;
- Severe abdominal or back pain due to confirmed pancreatic cancer
(surgical biopsy or EUS-FNA) .
- Presence of unrespectable pancreatic cancer (distant metastasis; the
invasion of celiac trunk or superior mesentery artery) or intolerability to
3
surgery because of other systemic disorders.
- Informed consent.
Key exclusion criteria - Patients whose general condition cannot tolerate an endoscopic
procedure.
- Patient refusal of the procedure.
- Acute abdominal complaint attributed to other causes.
- Coagulopathy that makes the procedure risky.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hussein Hassan Okasha
Organization Cairo university
Division name faculty of medicine
Zip code
Address 350 Port Said St. Bab El Khalk, Cairo
TEL 00201001000502
Email okasha.hussein@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name admin
Organization faculty of medicine
Division name research affair
Zip code
Address Kasr Al Ainy St. Cairo, Egypt
TEL 0020223682030
Homepage URL http://medicine.cu.edu.eg
Email Admin@kasralainy.edu.eg

Sponsor
Institute cairo univesity , faculty of medicine
Institute
Department

Funding Source
Organization cairo univesity , faculty of medicine
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2019 Year 04 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 01 Day
Last modified on
2017 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031154

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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