Radiofrequency Splanchnic Denervation ,neurolytic Retrocrural Celiac Plexus Block Chronic Upper Abdominal Cancer Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-08-01

Brief Summary

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

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Detailed Description

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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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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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radiofrequency splanchnic denervation

Radiofrequency ablation of splenic nerve. The nerves were then anesthetized with 2 mL of 2% lidocaine before RF performed. In RFA group, lesion will be performed at 80 degrees celsius for 3 lesions 2 minutes each on both sides.

Group Type ACTIVE_COMPARATOR

radiofrequency

Intervention Type DEVICE

block of neurolytic retrocrural celiac plexus block

Celiac plexuc block

Neurolytic ablation of the celiac plexus.Two milliliter of contrast material will be injected in each side for confirmation a test injection with 5 mL of 2% lidocaine to both sides, and wait for 5 minutes then inject 5 ml of 100% alcohol will in each side after 5 minutes to allow the local anesthetic to take action. 1 ml of 2%

Group Type ACTIVE_COMPARATOR

radiofrequency

Intervention Type DEVICE

block of neurolytic retrocrural celiac plexus block

Interventions

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radiofrequency

block of neurolytic retrocrural celiac plexus block

Intervention Type DEVICE

Other Intervention Names

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plexus block

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No