Back to resultsRadiofrequency Splanchnic Denervation Versus Retrocrural Neurolytic Celiac Block for Pancreatic Cancer Pain
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
radiofrequency splanchnic denervation
retrocrural celiac denervation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- patients with abdominal pain due to cancer pancreas
Exclusion Criteria:
- coagulopathy
- infection at site of the procedure
Sites / Locations
- DiabRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
radiofrequency splanchnic denervation
retrocrural celiac denervation
Arm Description
Outcomes
Primary Outcome Measures
the percentage of patients that gain more than 50% reduction of their pain on VAS pain score
VAS pain scale is a tool for measurement of pain intensity scored from 0 to 10 in which 0 + no pain and 10 + the worst pain immaginable
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03886298
Brief Title
Radiofrequency Splanchnic Denervation Versus Retrocrural Neurolytic Celiac Block for Pancreatic Cancer Pain
Official Title
For Patients With Pancreatic Cancer Pain, Does Radiofrequency Splanchnic Denervation Isprovide a Similar Analgesia as Neurolytic Celiac Block
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
April 10, 2020 (Anticipated)
Study Completion Date
June 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The investigators will evaluate the analgesic efficacy of radiofrequency splanchnic nerve denervation versus neurolytic retrocrural celiac denervation for patients with abdominal pain due to cancer pancreas
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
radiofrequency splanchnic denervation
Arm Type
Experimental
Arm Title
retrocrural celiac denervation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
radiofrequency splanchnic denervation
Intervention Description
the authors will denervate the splanchnic nerves via radiofrequency
Intervention Type
Procedure
Intervention Name(s)
retrocrural celiac denervation
Intervention Description
the authors will denervate the splanchnic nerves in the retrocrural space via injection of alcohol
Primary Outcome Measure Information:
Title
the percentage of patients that gain more than 50% reduction of their pain on VAS pain score
Description
VAS pain scale is a tool for measurement of pain intensity scored from 0 to 10 in which 0 + no pain and 10 + the worst pain immaginable
Time Frame
6 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with abdominal pain due to cancer pancreas
Exclusion Criteria:
coagulopathy
infection at site of the procedure
Facility Information:
Facility Name
Diab
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diab Hetta, MD
Phone
+201091090009
Email
diabgetta25@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Radiofrequency Splanchnic Denervation Versus Retrocrural Neurolytic Celiac Block for Pancreatic Cancer Pain
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