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Radiofrequency Splanchnic Denervation Versus Retrocrural Neurolytic Celiac Block for Pancreatic Cancer Pain

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ClinicalTrials.gov Identifier: NCT03886298
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Diab Fuad Hetta, Assiut University

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

Condition or disease Intervention/treatment Phase
Chronic Pain Procedure: radiofrequency splanchnic denervation Procedure: retrocrural celiac denervation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: For Patients With Pancreatic Cancer Pain, Does Radiofrequency Splanchnic Denervation Isprovide a Similar Analgesia as Neurolytic Celiac Block
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : April 10, 2020
Estimated Study Completion Date : June 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: radiofrequency splanchnic denervation Procedure: radiofrequency splanchnic denervation
the authors will denervate the splanchnic nerves via radiofrequency

Active Comparator: retrocrural celiac denervation Procedure: retrocrural celiac denervation
the authors will denervate the splanchnic nerves in the retrocrural space via injection of alcohol




Primary Outcome Measures :
  1. the percentage of patients that gain more than 50% reduction of their pain on VAS pain score [ Time Frame: 6 months postoperatively ]
    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



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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with abdominal pain due to cancer pancreas

Exclusion Criteria:

  • coagulopathy
  • infection at site of the procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886298


Locations
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Egypt
Diab Recruiting
Assiut, Assuit, Egypt, 71515
Contact: Diab Hetta, MD    +201091090009    diabgetta25@gmail.com   
Sponsors and Collaborators
Assiut University
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Responsible Party: Diab Fuad Hetta, Principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03886298    
Other Study ID Numbers: SECI-IRB-IORG0009563-725
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Cancer Pain
Pain
Neurologic Manifestations