UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and Safety of Endoscopic Ultrasound Guided Central versus Bilateral Celiac Plexus Neurolysis for Managing Abdominal Pain Associated with Pancreatic Cancer
Title of the study (Brief title)	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	Hussein Hassan Okasha
Organization	Cairo university
Division name	faculty of medicine
Address	350 Port Said St. Bab El Khalk, Cairo
TEL	00201001000502
Email	okasha.hussein@gmail.com

Public contact
Name of contact person	admin
Organization	faculty of medicine
Division name	research affair
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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