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Combined Fluoroscopy and CT Guided Radiofrequency Ablation of Thoracic Dorsal Root Ganglia in Severe Thoracic Pain

Primary Purpose

Cancer-related Problem/Condition

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
combined CT-fluroscopy
standard fluroscopy
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer-related Problem/Condition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients aged 18 years or more
  • suffering from chronic moderate-to-severe pain ( VAS score ≥ 40 mm)
  • due to malignancy involving the chest and pain was refractory to the maximally tolerated dose of opioids for at least four weeks. Malignancies included : lung cancer, pleural mesothelioma, chest wall tumors and metastatic deposits of the chest.

Exclusion Criteria:

  • sepsis, coagulopathy
  • malignant epidural invasion
  • distorted local anatomy
  • severe cardiorespiratory compromise
  • neuropsychiatric illness
  • history of drug dependence and known allergy to contrast media or the used medications.

Sites / Locations

  • Department of Anesthesia and Pain medicine.National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Interventional:Combined CT-fluroscopy

Interventional: standard fluroscopy

Arm Description

Combined CT-fluroscopic radiofrequency ablation of thoracic dorsal root ganglia.

Fluroscopic radiofrequency ablation of thoracic dorsal root ganglia.

Outcomes

Primary Outcome Measures

pain relief.
Pain intensity measured by visual analog scale (VAS).It measures the pain intensity and percentage of pain relief.The investigators used 100 mm horizontal scale with left zero end representing no pain and right 100 end representing worst pain.Scores ranging 0-39 reflect mild pain , 40-69 moderate pain and 70-100 severe pain.

Secondary Outcome Measures

patient satisfaction.
The secondary outcome measure will be assessed using patient satisfaction with the patient global impression of changes (PGIC).It measures the degree of patient overall satisfaction after the performed procedure. It includes 7 domains ranging from 1 to 7. the first domain indicates that the patient is very much improved while the 7th domain indicates that he is very much worsened by the procedure.

Full Information

First Posted
April 22, 2018
Last Updated
May 25, 2018
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT03533413
Brief Title
Combined Fluoroscopy and CT Guided Radiofrequency Ablation of Thoracic Dorsal Root Ganglia in Severe Thoracic Pain
Official Title
A Modified Technique of Combined Fluoroscopy and CT Guided Thermal Radiofrequency Ablation of Thoracic Dorsal Root Ganglia in Intractable Pain Associated With Thoracic Malignancies: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

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
In the current study, extra-guidance other than conventional fluoroscopy - will be integrated to improve the success of the transforaminal approach to the thoracic dorsal root ganglia (DRG). The investigators hypothesize that joining CT scan with fluoroscopy to guide RF ablation through the transforaminal route may enhance its efficacy and safety in relieving the intractable pain associated with chest malignancies. The current study aimed to compare the results of thermal radiofrequency ablation (TRFA) of the thoracic DRG under combined CT and fluoroscopy guidance with the classic standard fluoroscopy technique.
Detailed Description
Thoracic pain represents about 3-5% of pain clinics' visitors worldwide .Post-thoracotomy pain occurs in 30%-50% of patients undergoing thoracotomy .Interventional therapies include epidural or intrathecal drug injection, intercostal nerve block, sympathectomy, rhizotomy, and percutaneous cervical cordotomy. Rhizotomy refers to the selective segmental destruction of the dorsal sensory rootlets to interrupt pain perception by the spinal cord. This could be accomplished either neurosurgically, chemically or using selective percutaneous procedures such as cryoanalgesia and radiofrequency (RF) ablation.There are many technical difficulties in approaching the deep-seated thoracic dorsal root ganglia (DRG) through the transforaminal route.The spine is kyphotic - with the tip at T6 - and slightly scoliotic to the right side even in normal subjects . Spinous processes are acute, especially at T5-T8 level. Besides, broad and wide laminae together with narrow intervertebral foramina are other obstacles .The intervertebral foramina are further masked by the facet joints and the crowdedness of the costovertebral and the costotransverse joints .For all these factors, more guidance - other than conventional fluoroscopy - may improve the success of the transforaminal approach to the thoracic DRG. The investigators hypothesize that joining CT scan with fluoroscopy to guide RF ablation through the transforaminal route can enhance its efficacy and safety in relieving the intractable pain of chest malignancies. The current study aimed to compare the results of thermal radiofrequency ablation (TRFA) of the thoracic DRG under combined CT and fluoroscopy guidance with the classic standard fluoroscopy technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Problem/Condition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional:Combined CT-fluroscopy
Arm Type
Active Comparator
Arm Description
Combined CT-fluroscopic radiofrequency ablation of thoracic dorsal root ganglia.
Arm Title
Interventional: standard fluroscopy
Arm Type
Active Comparator
Arm Description
Fluroscopic radiofrequency ablation of thoracic dorsal root ganglia.
Intervention Type
Procedure
Intervention Name(s)
combined CT-fluroscopy
Intervention Description
Radiofrequency ablation of thoracic dorsal root ganglia guided by combined CT-Fluroscopy
Intervention Type
Procedure
Intervention Name(s)
standard fluroscopy
Intervention Description
Radiofrequency ablation of thoracic dorsal root ganglia guided by standard fluroscopy only
Primary Outcome Measure Information:
Title
pain relief.
Description
Pain intensity measured by visual analog scale (VAS).It measures the pain intensity and percentage of pain relief.The investigators used 100 mm horizontal scale with left zero end representing no pain and right 100 end representing worst pain.Scores ranging 0-39 reflect mild pain , 40-69 moderate pain and 70-100 severe pain.
Time Frame
12 weeks follow up
Secondary Outcome Measure Information:
Title
patient satisfaction.
Description
The secondary outcome measure will be assessed using patient satisfaction with the patient global impression of changes (PGIC).It measures the degree of patient overall satisfaction after the performed procedure. It includes 7 domains ranging from 1 to 7. the first domain indicates that the patient is very much improved while the 7th domain indicates that he is very much worsened by the procedure.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients aged 18 years or more suffering from chronic moderate-to-severe pain ( VAS score ≥ 40 mm) due to malignancy involving the chest and pain was refractory to the maximally tolerated dose of opioids for at least four weeks. Malignancies included : lung cancer, pleural mesothelioma, chest wall tumors and metastatic deposits of the chest. Exclusion Criteria: sepsis, coagulopathy malignant epidural invasion distorted local anatomy severe cardiorespiratory compromise neuropsychiatric illness history of drug dependence and known allergy to contrast media or the used medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab H Shaker, MD
Organizational Affiliation
National Cancer Institute- Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia and Pain medicine.National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be a shared team work study during which all the investigators will have equally distributed roles.
Citations:
PubMed Identifier
31852438
Citation
Reyad RM, Ghobrial HZ, Shaker EH, Reyad EM, Shaaban MH, Hashem RH, Darwish WM. Modified technique for thermal radiofrequency ablation of Thoracic dorsal root ganglia under combined fluoroscopy and CT guidance: a randomized clinical trial. BMC Anesthesiol. 2019 Dec 18;19(1):234. doi: 10.1186/s12871-019-0906-4.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/8788580
Description
clinical journal of pain

Learn more about this trial

Combined Fluoroscopy and CT Guided Radiofrequency Ablation of Thoracic Dorsal Root Ganglia in Severe Thoracic Pain

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