Clinical trial NCT06678061: Radiofrequency Splanchnic Denervation ,neurolytic Retrocrural Celiac Plexus Block Chronic Upper Abdominal Cancer Pain
Official title: Efficacy of Radiofrequency Splanchnic Denervation Compared to Neurolytic Retrocrural Celiac Plexus Block for Patients with Chronic Upper Abdominal Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare between the efficacy of radiofrequency splanchnic denervation and neurolytic retrocrural celiac plexus block in chronic upper abdominal cancer pain

Detailed description: Abdominal cancers are not uncommon, according to WHO latest updates in cancer epidemiology published in 2020, the percentage of new cases incidence is rapidly increasing as follow: Colon (6.0%), Stomach (5.6%), Liver (4.7%), Esophagus (3.1%), Pancreas (2.6%), and Gall bladder (0.6%).

Pain is one of the chief complains in cancer patients and the leading cause for seeking medical advice. In abdominal malignancies, visceral pain is poorly localized due to both fewer receptors participating in the process of visceral pain and the scarce representation within the primary somatosensory cortex. The challenge in identifying the pain generators and effectively treat this condition explains the tendency for abdominal pain to become chronic and frustration associated with its management for both the patient and the health care provider. Effective analgesia has become sometimes difficult to institute in abdominal cancer patients because the dose-response is unpredictable and the analgesic doses may be poorly tolerated in patients who are debilitated and using several other drugs as they are usually old age, complaining of nausea, repeated vomiting, and dehydration, elevated liver enzymes especially in liver affection by primary or secondary lesions.

Many patients may have residual symptoms that impact their quality of life despite thoughtful pharmacologic and surgical treatment. So, Non pharmacologic strategies, including physical therapy, integrated and complementary medicine, lifestyle modifications, and interventional procedures may also be useful adjuncts to surgical and pharmacologic therapy.

Thus, the neurolytic sympathetic block has been proposed as an efficient, relatively simple, and repeatable method of management, bringing both relief of pain and allowing the discontinuation of drugs or at least a decrease in their dosage.

Frequently used nerve ablation and modulation methods include conventional radiofrequency ablation (RFA) using heat and chemical ablation using alcohol.

The celiac plexus lies anterior to aorta at the level of the first lumber vertebra. A block of the celiac plexus is applied most commonly to patients with pancreatic, gastric, or biliary cancer, as such patients typically have severe intractable upper abdominal pain . Splanchnic nerves are paired nerves arising from the thoracic sympathetic trunk (ganglia 5 to 12) which pierce the crura of the diaphragm at the T11 and T12 levels to join the celiac ganglion. Interruption of these nerve fibers can provide relief from pain associated with intra-abdominal malignancies .Neurolysis reduces pain by disrupting pain signals along the neural pathway The celiac plexus and splanchnic nerves are targets for neurolytic blocks for pain relief from pain caused by upper gastrointestinal tumors. And in this trial we are aiming to compare between the efficacies of both techniques in the management of chronic upper abdominal cancer pain.

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Eligibility criteria: Inclusion Criteria:

1. Patients aged from 20-70 years old, with upper GIT tumors, including cancer of the lower third of the esophagus, stomach cancer, pancreatic cancer, cancer liver, and cancer of the biliary tract,
2. Abdominal cancer pain: includes patients with NRS pain score ≥ 5. \[16\]
3. Included participants should show adequate response to diagnostic block for the splanchnic nerves, i.e. reduction of NRS pain score \> 50% at least for 2 hours

Exclusion Criteria:

- a- Patient's refusal. b- Patients medical condition as: coagulopathies, moderate or major cardiac/respiratory incapacitating diseases, liver or renal failure, infection either systemic or localized and anatomical anomalies or lesions at the spine.

c- Any psychiatric illness that would interfere with the perception and the assessment of pain, and any reason that would result in the protocol violation

Primary outcomes:
measure: the Numeric Pain Rating Scale (NRS) pain scale
timeFrame: 6 months
Secondary outcomes:
measure: 1- Total opioid consumption
timeFrame: 6 months
measure: Functional Assessment of Chronic Illness Therapy or Cancer Therapy (FACT)
timeFrame: 6 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute
Study officials:
affiliation: AssiutUniversity
name: Dr. Samy Erfan, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Nourhan Elgallay, Msc
role: PRINCIPAL_INVESTIGATOR
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