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

July 3, 2019 updated by: Diab Fuad Hetta, Assiut University

For Patients With Pancreatic Cancer Pain, Does Radiofrequency Splanchnic Denervation Isprovide a Similar Analgesia as Neurolytic Celiac Block

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, 71515
        • Recruiting
        • Diab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with abdominal pain due to cancer pancreas

Exclusion Criteria:

  • coagulopathy
  • infection at site of the procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 10, 2019

Primary Completion (ANTICIPATED)

April 10, 2020

Study Completion (ANTICIPATED)

June 10, 2020

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (ACTUAL)

March 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SECI-IRB-IORG0009563-725

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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