CancerNCT06678061
Radiofrequency Splanchnic Denervation ,Neurolytic Retrocrural Celiac Plexus Block Chronic Upper Abdominal Cancer Pain
A study testing radiofrequency in people with Cancer, run by Assiut University at 2 sites in Egypt.
Trial summary
To compare between the efficacy of radiofrequency splanchnic denervation and neurolytic retrocrural celiac plexus block in chronic upper abdominal cancer pain Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cancer
- What is being tested?
- radiofrequency
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Feb 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
- Abdominal cancer pain: includes patients with NRS pain score ≥ 5. [16]
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Assiut University
Asyut, Asyut Governorate, 71515
South Egypt Cancer Institute
Asyut, Asyut Governorate, 71515
About this study
Official title: Efficacy of Radiofrequency Splanchnic Denervation Compared to Neurolytic Retrocrural Celiac Plexus Block for Patients With Chronic Upper Abdominal Cancer Pain
To compare between the efficacy of radiofrequency splanchnic denervation and neurolytic retrocrural celiac plexus block in chronic upper abdominal cancer pain
Read the 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.
:
- Conditions
- Cancer
- Being tested
- radiofrequency
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequencyDevice
Also called plexus block
block of neurolytic retrocrural celiac plexus block
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency splanchnic denervation | Active comparator | 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. Receives: Device: radiofrequency |
| Celiac plexuc block | Active comparator | 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% Receives: Device: radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Numeric Pain Rating Scale (NRS) pain scale
Change in the Numeric Pain Rating Scale (NRS) pain scale at the first 2 weeks compared to the pre-procedural pain
Measured: 6 months
Secondary outcomes (3)
1- Total opioid consumption
daily consumption of opioid
Measured: 6 months
Functional Assessment of Chronic Illness Therapy or Cancer Therapy (FACT)
measure patient quality of life
Measured: 6 months
Patient Health Questionnaire (PHQ-9)
measure depression and anxiety
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Feb 2024
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NourhanMohammedAlaaElgalaly, Assiut University
- Investigators
- Dr. Samy Erfan, MD, Study director, AssiutUniversityNourhan Elgallay, Msc, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678061
- Sponsor's protocol ID
- ERSDCNRCPBPCUACP
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gilbody S, Richards D, Brealey S, Hewitt C. Screening for depression in medical settings with the Patient Health Questionnaire (PHQ): a diagnostic meta-analysis. J Gen Intern Med. 2007 Nov;22(11):1596-602. doi: 10.1007/s11606-007-0333-y. Epub 2007 Sep 14.
PubMed 17874169Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.
PubMed 18388841Cherny N, Ripamonti C, Pereira J, Davis C, Fallon M, McQuay H, Mercadante S, Pasternak G, Ventafridda V; Expert Working Group of the European Association of Palliative Care Network. Strategies to manage the adverse effects of oral morphine: an evidence-based report. J Clin Oncol. 2001 May 1;19(9):2542-54. doi: 10.1200/JCO.2001.19.9.2542.
PubMed 11331334Miguel R. Interventional treatment of cancer pain: the fourth step in the World Health Organization analgesic ladder? Cancer Control. 2000 Mar-Apr;7(2):149-56. doi: 10.1177/107327480000700205.
PubMed 10783819Peipert JD, Cella D. Bifactor analysis confirmation of the factorial structure of the Functional Assessment of Cancer Therapy-General (FACT-G). Psychooncology. 2019 May;28(5):1149-1152. doi: 10.1002/pon.5062. Epub 2019 Apr 17. No abstract available.
PubMed 30883962Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
PubMed 15621359
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Radiofrequency Splanchnic Denervation Compared to Neurolytic Retrocrural Celiac Plexus Block for Patients With Chronic Upper Abdominal Cancer Pain
- ClinicalTrials.gov ID
- NCT06678061
- Acronym / sponsor ID
- ERSDCNRCPBPCUACP
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiofrequency splanchnic denervation | Active comparator | Device: radiofrequencyRadiofrequency 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. |
| Celiac plexuc block | Active comparator | Device: radiofrequencyNeurolytic 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% |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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,
- Abdominal cancer pain: includes patients with NRS pain score ≥ 5. [16]
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequencyAlso: plexus blockblock of neurolytic retrocrural celiac plexus block | Device | Celiac plexuc block, radiofrequency splanchnic denervation |
Primary outcome
the Numeric Pain Rating Scale (NRS) pain scale
Time frame: 6 months
Change in the Numeric Pain Rating Scale (NRS) pain scale at the first 2 weeks compared to the pre-procedural pain
3 secondary outcomes
1- Total opioid consumption
Time frame: 6 months
Functional Assessment of Chronic Illness Therapy or Cancer Therapy (FACT)
Time frame: 6 months
Patient Health Questionnaire (PHQ-9)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Results publication: PubMed 17874169Gilbody S, Richards D, Brealey S, Hewitt C. Screening for depression in medical settings with the Patient Health Questionnaire (PHQ): a diagnostic meta-analysis. J Gen Intern Med. 2007 Nov;22(11):1596-602. doi: 10.1007/s11606-007-0333-y. Epub 2007 Sep 14.
- Results publication: PubMed 18388841Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.
- Results publication: PubMed 11331334Cherny N, Ripamonti C, Pereira J, Davis C, Fallon M, McQuay H, Mercadante S, Pasternak G, Ventafridda V; Expert Working Group of the European Association of Palliative Care Network. Strategies to manage the adverse effects of oral morphine: an evidence-based report. J Clin Oncol. 2001 May 1;19(9):2542-54. doi: 10.1200/JCO.2001.19.9.2542.
- Results publication: PubMed 10783819Miguel R. Interventional treatment of cancer pain: the fourth step in the World Health Organization analgesic ladder? Cancer Control. 2000 Mar-Apr;7(2):149-56. doi: 10.1177/107327480000700205.
- Results publication: PubMed 30883962Peipert JD, Cella D. Bifactor analysis confirmation of the factorial structure of the Functional Assessment of Cancer Therapy-General (FACT-G). Psychooncology. 2019 May;28(5):1149-1152. doi: 10.1002/pon.5062. Epub 2019 Apr 17. No abstract available.
- Results publication: PubMed 15621359Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Samy Erfan, MD study director
AssiutUniversity
Nourhan Elgallay, Msc principal investigator
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency in people with Cancer, run by Assiut University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Numeric Pain Rating Scale (NRS) pain scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06678061, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.