Clinical trial NCT03533413: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Problem/Condition
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: pain relief.
timeFrame: 12 weeks follow up
Secondary outcomes:
measure: patient satisfaction.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Anesthesia and Pain medicine.National Cancer Institute
Study officials:
affiliation: National Cancer Institute- Cairo University
name: Ehab H Shaker, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.