Cancer, Malignant TumorsCONCERNNCT06978673
Neurolytic Block Techniques In Abdominal Visceral Cancer Pain
A study testing Splanchnic nerve neurolysis - 5 ml of absolute alcohol (100%) and Celiac Plexus Neurolysis - 5 ml of absolute alcohol (100%) in people with Cancer, Malignant Tumors and Abdominal Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
The neurolytic blocks of sympathetic chains are commonly used for the treatment of cancer-related pain. This study aims to compare celiac plexus neurolysis and splanchnic nerve neurolysis for the treatment of abdominal visceral pain and its influence on the quality of life of patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Malignant Tumors, Abdominal Cancer, Cancer Pain
- What is being tested?
- Splanchnic nerve neurolysis - 5 ml of absolute alcohol (100%) and Celiac Plexus Neurolysis - 5 ml of absolute alcohol (100%)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- 30 May 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older Presence of localized visceral pain in the upper abdomen originating from cancer of the stomach, duodenum, distal esophagus, ascending or transverse colon, liver, biliary tract, or pancreas
- Ineffectiveness of analgesic treatment with third-step opioids according to the WHO analgesic ladder, including:
- Opioids (≥ 60 mg/day of morphine equivalents) Antidepressants (tricyclic or dual-action), at any dosage Gabapentinoids, at any dosage Presence of side effects from analgesics that are difficult to manage with medication
Who cannot join
- Presence of ascites Presence of deep vein thrombosis Presence of hepatic failure: Child-Pugh class B or C Presence of renal failure: estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m² Use of any anticoagulant medication
- Clinical coagulation disorder, defined as:
- INR > 1.5 Prothrombin activity < 70% or prothrombin time > 13.5 seconds aPTT > 40 seconds Cardiovascular failure: NYHA class III
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Instituto de Cancer Do Estado
São Paulo, São Paulo, 01246-000
Karenthan A Rodrigues, MD., +55 11 998110737, karenthan.abreu@hc.fm.usp.br
Angela M Sousa, MD. PhD., +55 11 38933268, angela.sousa@hc.fm.usp.br
About this study
Official title: Comparison of Neurolytic Block Techniques for the Treatment of Abdominal Visceral Pain and Their Influence On The Quality of Life of Patients With Cancer
The neurolytic blocks of sympathetic chains are commonly used for the treatment of cancer-related pain. This study aims to compare celiac plexus neurolysis and splanchnic nerve neurolysis for the treatment of abdominal visceral pain and its influence on the quality of life of patients with cancer.
Read the detailed description
Double-blind randomized clinical trial.
The objective of the study is to compare the analgesic efficacy of splanchnic nerve neurolysis with alcohol to celiac plexus block with alcohol, with pain relief as the primary outcome. It also aims to quantify the adverse effects of the techniques as secondary outcomes. The sample size calculation will be based on comparing the mean pain scores on the Numerical Rating Scale of patients in the Control Group and the Intervention Group, evaluated after completing the second month of treatment. A two-tailed t-test will be sufficient and will require an adequate sample size. Therefore, for the chosen sample design with a significance level of α=5%, a power of 1-β=80%, assuming M1=5.0 and M2=3.5 and a standard deviation of 2.0, the sample size required is n=58. the sample size required is n=58. Considering a 10% dropout rate, the final sample size will be increased to 64 participants. Convenience sampling (a non-probabilistic sampling method) will be used. Participants will be randomly allocated to the groups using a list generated by a program obtained at https://www.randomizer.org. The proportion between the participants in the groups will be 1:1, with 32 patients allocated to the Intervention arm and 32 to the Control arm. The allocation of the total 64 participants will be determined by randomly assigned sequential letters (A or B) generated by the computer (website https://www.randomizer.org), randomly assigning numbers from 0 to 64 to each group: Control Group (Celiac Block) and Intervention Group (Splanchnic Nerve Block). The Control Group will receive celiac plexus neurolysis with absolute alcohol, and the Intervention Group will receive splanchnic nerve neurolysis with alcohol. The statistical analysis will be performed in program R version 3.5.1. The results obtained will be presented as mean + standard deviation for continuous data or absolute frequency for described data. For quantitative variables, the Student's t-test will be used for normally distributed data, or the Mann-Whitney test for non-normally distributed data. For qualitative variables, the chi-square test will be used or Fisher's exact test. Significant difference is defined as p < 0.05. Data will be collected and managed using REDCap data capture tools.
- Conditions
- Cancer, Malignant Tumors, Abdominal Cancer, Cancer Pain, Visceral Pain, Cancer-related Pain, Pain Management
- Being tested
- Splanchnic nerve neurolysis - 5 ml of absolute alcohol (100%), Celiac Plexus Neurolysis - 5 ml of absolute alcohol (100%)
- Keywords
- cancer pain, visceral pain, abdominal cancer, cancer, abdominal pain, cancer-related pain, pain management, neurolytic block, splanchnic nerve block, celiac plexus block, sympathetic neurolysis
- Medical subject headings
- Neoplasms, Cancer Pain, Visceral Pain, Agnosia, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splanchnic nerve neurolysis - 5 ml of absolute alcohol (100%)Procedure or surgery
Also called SPLANCHNIC NERVE BLOCK, SPLANCHNIC NERVE BLOCKADE, SPLANCHNIC BLOCK
Splanchnic neurolysis will be performed with 5 ml of absolute alcohol on each side at the level of the eleventh thoracic vertebra.
Celiac Plexus Neurolysis - 5 ml of absolute alcohol (100%)Procedure or surgery
Also called Celiac plexus block
Celiac plexus neurolysis will be performed with 5 ml of absolute alcohol on each side at the level of the first lumbar vertebra.
| Study group | Role | What they receive |
|---|---|---|
| CELIAC PLEXUS NEUROLYSIS | Active comparator | The patient, under sedation and breathing spontaneously with oxygen support, will be placed in the horizontal prone position. Fluoroscopy will be used to locate the first lumbar vertebra, which will serve as a reference for the puncture site. Two 22G × 15 cm needles will be introduced bilaterally, up to 6 cm from the midline at the level of L1, and directed superiorly toward the transverse process of L1 under coaxial vision. Once they reach the vertebral body bilaterally, the needles will be positioned anterior to the vertebral body of L1, in the retroperitoneal region. The needle stylet will be removed, and the absence of blood, cerebrospinal fluid, or urine returning through the needle will be verified. If none of these signs are present, 2 ml of non-ionic contrast will be administered through the needle to confirm proper positioning in the retroperitoneum. After confirmation, 5 ml of absolute alcohol will be injected bilaterally. Receives: Procedure: Celiac Plexus Neurolysis - 5 ml of absolute alcohol (100%) |
| SPLANCHNIC NERVE NEUROLYSIS | Experimental | The patient, under spontaneous breathing with oxygen support, will be placed in the horizontal prone position and supported by cushions placed under the iliac crests and chest. With a mark maintained over T11, the fluoroscopy machine will be positioned obliquely (approximately 45º), and the movement of the diaphragm-as well as its relationship with the vertebral body-will be observed during inspiration and expiration. The entry point will be at the junction of the rib and the vertebral body. The needle will be introduced using coaxial visualization to reach the lateral aspect of the vertebral body, near the costovertebral angle. With the fluoroscopy in profile, the needle will be advanced to the anterior third of the vertebral body, and any return of blood or cerebrospinal fluid will be checked. Non-ionic contrast will then be injected to confirm the needle position in both anteroposterior and lateral views. Finally, 5 ml of absolute alcohol will be injected through each needle. Receives: Procedure: Splanchnic nerve neurolysis - 5 ml of absolute alcohol (100%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAIN SCORE
Pain will be assessed using the Numerical Rating Scale (NRS), a scale from 0 to 10 where: 0 indicates no pain and 10 indicates the worst possible pain.
Scores are typically categorized as:
Mild pain: 0-3 Moderate pain: 4-6 Severe pain: 7-10
Additionally, the Descriptive Verbal Scale will be used, with the following categories:
No pain Mild pain Moderate pain Severe pain.
Measured: 1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure
Secondary outcomes (2)
Quality of life assessment.
Quality of life will be assessed using the Brief Pain Inventory - Short Form (SF-36) questionnaire, which evaluates both pain intensity and its impact on daily functioning.
The questionnaire covers two main areas:
Pain Severity - Patients rate their pain at its:
Worst Least Average Current (right now) (using a 0-10 numeric scale, where 0 = no pain and 10 = pain as bad as you can imagine).
Pain Interference - Assesses how much pain interferes with:
General activity Mood Walking ability Normal work Relationships with others Sleep Enjoyment of life (also rated on a 0-10 scale, where 0 = does not interfere and 10 = completely interferes).
Additionally, the questionnaire includes:
A pain location diagram Information about current pain medications and their effectiveness Description of pain relief methods.
Measured: 1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure
Adverse Events
Adverse events inherent to the studied procedures will be assessed and recorded. These include:
Abdominal pain; Diarrhea; Hypotension (low blood pressure); Back pain; Nausea and vomiting; Fever; Bloating or abdominal distention; Delayed gastric emptying; Injury to surrounding structures (e.g., blood vessels or organs); Nerve damage; Impaired digestive function; Local infection at the puncture site; Loss of autonomic function; Pneumothorax.
Measured: 1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start30 May 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cancer, Malignant TumorsStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, amsousa, Instituto do Cancer do Estado de São Paulo
- Investigators
- Angela M Sousa, MD. PhD., Study director, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978673
- Sponsor's protocol ID
- NP 076-210
- Acronym
- CONCERN
- Status last verified
- May 2025
- First submitted
- 10 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koyyalagunta D, Engle MP, Yu J, Feng L, Novy DM. The Effectiveness of Alcohol Versus Phenol Based Splanchnic Nerve Neurolysis for the Treatment of Intra-Abdominal Cancer Pain. Pain Physician. 2016 May;19(4):281-92.
PubMed 27228515Ahmed A, Arora D. Fluoroscopy-guided Neurolytic Splanchnic Nerve Block for Intractable Pain from Upper Abdominal Malignancies in Patients with Distorted Celiac Axis Anatomy: An Effective Alternative to Celiac Plexus Neurolysis - A Retrospective Study. Indian J Palliat Care. 2017 Jul-Sep;23(3):274-281. doi: 10.4103/IJPC.IJPC_28_17.
PubMed 28827930Uehara Y, Matsumoto Y, Kosugi T, Sone M, Nakamura N, Mizushima A, Miyashita M, Morita T, Yamaguchi T, Satomi E. Availability of and factors related to interventional procedures for refractory pain in patients with cancer: a nationwide survey. BMC Palliat Care. 2022 Sep 26;21(1):166. doi: 10.1186/s12904-022-01056-6.
PubMed 36154936Hochberg U, Ingelmo P, Sole E, Miro J, Rivera G, Perez J. Early Interventional Treatments for Patients with Cancer Pain: A Narrative Review. J Pain Res. 2023 May 18;16:1663-1671. doi: 10.2147/JPR.S405808. eCollection 2023.
PubMed 37223437Noble M, Gress FG. Techniques and results of neurolysis for chronic pancreatitis and pancreatic cancer pain. Curr Gastroenterol Rep. 2006 Apr;8(2):99-103. doi: 10.1007/s11894-006-0004-x.
PubMed 16533471Comlek S. Pain Control with Splanchnic Neurolysis in Pancreatic Cancer Patients Unresponsive to Celiac Plexus Neurolysis. J Pain Res. 2020 Aug 12;13:2023-2031. doi: 10.2147/JPR.S266689. eCollection 2020.
PubMed 32848449Yamamuro M, Kusaka K, Kato M, Takahashi M. Celiac plexus block in cancer pain management. Tohoku J Exp Med. 2000 Sep;192(1):1-18. doi: 10.1620/tjem.192.1.
PubMed 11128864Paul A, Borkar A. Fluoroscopy-Guided Splanchnic Nerve Block for Cancer-Associated Pain. Cureus. 2022 Oct 31;14(10):e30944. doi: 10.7759/cureus.30944. eCollection 2022 Oct.
PubMed 36465781Lu F, Li X, Song L, Ye L, Wang X, Wang R. Efficacy and Safety of Celiac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis in the Management of Abdominal Cancer Pain: A Meta-analysis of 359 Patients. Pain Physician. 2024 Jan;27(1):1-10.
PubMed 38285023
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Neurolytic Block Techniques for the Treatment of Abdominal Visceral Pain and Their Influence On The Quality of Life of Patients With Cancer
- ClinicalTrials.gov ID
- NCT06978673
- Acronym / sponsor ID
- CONCERN / NP 076-210
- Conditions
- Cancer, Malignant Tumors, Abdominal Cancer, Cancer Pain, Visceral Pain, Cancer-related Pain, Pain Management
- Keywords
- cancer pain, visceral pain, abdominal cancer, cancer, abdominal pain, cancer-related pain, pain management, neurolytic block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 May 2025 (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.
The neurolytic blocks of sympathetic chains are commonly used for the treatment of cancer-related pain. This study aims to compare celiac plexus neurolysis and splanchnic nerve neurolysis for the treatment of abdominal visceral pain and its influence on the quality of life of patients with cancer.
Detailed description
Double-blind randomized clinical trial.
The objective of the study is to compare the analgesic efficacy of splanchnic nerve neurolysis with alcohol to celiac plexus block with alcohol, with pain relief as the primary outcome. It also aims to quantify the adverse effects of the techniques as secondary outcomes. The sample size calculation will be based on comparing the mean pain scores on the Numerical Rating Scale of patients in the Control Group and the Intervention Group, evaluated after completing the second month of treatment. A two-tailed t-test will be sufficient and will require an adequate sample size. Therefore, for the chosen sample design with a significance level of α=5%, a power of 1-β=80%, assuming M1=5.0 and M2=3.5 and a standard deviation of 2.0, the sample size required is n=58. the sample size required is n=58. Considering a 10% dropout rate, the final sample size will be increased to 64 participants. Convenience sampling (a non-probabilistic sampling method) will be used. Participants will be randomly allocated to the groups using a list generated by a program obtained at https://www.randomizer.org. The proportion between the participants in the groups will be 1:1, with 32 patients allocated to the Intervention arm and 32 to the Control arm. The allocation of the total 64 participants will be determined by randomly assigned sequential letters (A or B) generated by the computer (website https://www.randomizer.org), randomly assigning numbers from 0 to 64 to each group: Control Group (Celiac Block) and Intervention Group (Splanchnic Nerve Block). The Control Group will receive celiac plexus neurolysis with absolute alcohol, and the Intervention Group will receive splanchnic nerve neurolysis with alcohol. The statistical analysis will be performed in program R version 3.5.1. The results obtained will be presented as mean + standard deviation for continuous data or absolute frequency for described data. For quantitative variables, the Student's t-test will be used for normally distributed data, or the Mann-Whitney test for non-normally distributed data. For qualitative variables, the chi-square test will be used or Fisher's exact test. Significant difference is defined as p < 0.05. Data will be collected and managed using REDCap data capture tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CELIAC PLEXUS NEUROLYSIS | Active comparator | Procedure: Celiac Plexus Neurolysis - 5 ml of absolute alcohol (100%)The patient, under sedation and breathing spontaneously with oxygen support, will be placed in the horizontal prone position. Fluoroscopy will be used to locate the first lumbar vertebra, which will serve as a reference for the puncture site. Two 22G × 15 cm needles will be introduced bilaterally, up to 6 cm from the midline at the level of L1, and directed superiorly toward the transverse process of L1 under coaxial vision. Once they reach the vertebral body bilaterally, the needles will be positioned anterior to the vertebral body of L1, in the retroperitoneal region. The needle stylet will be removed, and the absence of blood, cerebrospinal fluid, or urine returning through the needle will be verified. If none of these signs are present, 2 ml of non-ionic contrast will be administered through the needle to confirm proper positioning in the retroperitoneum. After confirmation, 5 ml of absolute alcohol will be injected bilaterally. |
| SPLANCHNIC NERVE NEUROLYSIS | Experimental | Procedure: Splanchnic nerve neurolysis - 5 ml of absolute alcohol (100%)The patient, under spontaneous breathing with oxygen support, will be placed in the horizontal prone position and supported by cushions placed under the iliac crests and chest. With a mark maintained over T11, the fluoroscopy machine will be positioned obliquely (approximately 45º), and the movement of the diaphragm-as well as its relationship with the vertebral body-will be observed during inspiration and expiration. The entry point will be at the junction of the rib and the vertebral body. The needle will be introduced using coaxial visualization to reach the lateral aspect of the vertebral body, near the costovertebral angle. With the fluoroscopy in profile, the needle will be advanced to the anterior third of the vertebral body, and any return of blood or cerebrospinal fluid will be checked. Non-ionic contrast will then be injected to confirm the needle position in both anteroposterior and lateral views. Finally, 5 ml of absolute alcohol will be injected through each needle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years or older Presence of localized visceral pain in the upper abdomen originating from cancer of the stomach, duodenum, distal esophagus, ascending or transverse colon, liver, biliary tract, or pancreas
- Ineffectiveness of analgesic treatment with third-step opioids according to the WHO analgesic ladder, including:
- Opioids (≥ 60 mg/day of morphine equivalents) Antidepressants (tricyclic or dual-action), at any dosage Gabapentinoids, at any dosage Presence of side effects from analgesics that are difficult to manage with medication
Key exclusion criteria (3 listed)
- Presence of ascites Presence of deep vein thrombosis Presence of hepatic failure: Child-Pugh class B or C Presence of renal failure: estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m² Use of any anticoagulant medication
- INR > 1.5 Prothrombin activity < 70% or prothrombin time > 13.5 seconds aPTT > 40 seconds Cardiovascular failure: NYHA class III
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 |
|---|---|---|
| Splanchnic nerve neurolysis - 5 ml of absolute alcohol (100%)Also: SPLANCHNIC NERVE BLOCK, SPLANCHNIC NERVE BLOCKADE, SPLANCHNIC BLOCKSplanchnic neurolysis will be performed with 5 ml of absolute alcohol on each side at the level of the eleventh thoracic vertebra. | Procedure or surgery | SPLANCHNIC NERVE NEUROLYSIS |
| Celiac Plexus Neurolysis - 5 ml of absolute alcohol (100%)Also: Celiac plexus blockCeliac plexus neurolysis will be performed with 5 ml of absolute alcohol on each side at the level of the first lumbar vertebra. | Procedure or surgery | CELIAC PLEXUS NEUROLYSIS |
Primary outcome
PAIN SCORE
Time frame: 1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure
Pain will be assessed using the Numerical Rating Scale (NRS), a scale from 0 to 10 where: 0 indicates no pain and 10 indicates the worst possible pain. Scores are typically categorized as: Mild pain: 0-3 Moderate pain: 4-6 Severe pain: 7-10 Additionally, the Descriptive Verbal Scale will be used, with the following categories: No pain Mild pain Moderate pain Severe pain.
2 secondary outcomes
Quality of life assessment.
Time frame: 1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure
Adverse Events
Time frame: 1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 27228515Koyyalagunta D, Engle MP, Yu J, Feng L, Novy DM. The Effectiveness of Alcohol Versus Phenol Based Splanchnic Nerve Neurolysis for the Treatment of Intra-Abdominal Cancer Pain. Pain Physician. 2016 May;19(4):281-92.
- Background: PubMed 28827930Ahmed A, Arora D. Fluoroscopy-guided Neurolytic Splanchnic Nerve Block for Intractable Pain from Upper Abdominal Malignancies in Patients with Distorted Celiac Axis Anatomy: An Effective Alternative to Celiac Plexus Neurolysis - A Retrospective Study. Indian J Palliat Care. 2017 Jul-Sep;23(3):274-281. doi: 10.4103/IJPC.IJPC_28_17.
- Background: PubMed 36154936Uehara Y, Matsumoto Y, Kosugi T, Sone M, Nakamura N, Mizushima A, Miyashita M, Morita T, Yamaguchi T, Satomi E. Availability of and factors related to interventional procedures for refractory pain in patients with cancer: a nationwide survey. BMC Palliat Care. 2022 Sep 26;21(1):166. doi: 10.1186/s12904-022-01056-6.
- Background: PubMed 37223437Hochberg U, Ingelmo P, Sole E, Miro J, Rivera G, Perez J. Early Interventional Treatments for Patients with Cancer Pain: A Narrative Review. J Pain Res. 2023 May 18;16:1663-1671. doi: 10.2147/JPR.S405808. eCollection 2023.
- Background: PubMed 16533471Noble M, Gress FG. Techniques and results of neurolysis for chronic pancreatitis and pancreatic cancer pain. Curr Gastroenterol Rep. 2006 Apr;8(2):99-103. doi: 10.1007/s11894-006-0004-x.
- Background: PubMed 32848449Comlek S. Pain Control with Splanchnic Neurolysis in Pancreatic Cancer Patients Unresponsive to Celiac Plexus Neurolysis. J Pain Res. 2020 Aug 12;13:2023-2031. doi: 10.2147/JPR.S266689. eCollection 2020.
- Background: PubMed 11128864Yamamuro M, Kusaka K, Kato M, Takahashi M. Celiac plexus block in cancer pain management. Tohoku J Exp Med. 2000 Sep;192(1):1-18. doi: 10.1620/tjem.192.1.
- Background: PubMed 36465781Paul A, Borkar A. Fluoroscopy-Guided Splanchnic Nerve Block for Cancer-Associated Pain. Cureus. 2022 Oct 31;14(10):e30944. doi: 10.7759/cureus.30944. eCollection 2022 Oct.
- Background: PubMed 38285023Lu F, Li X, Song L, Ye L, Wang X, Wang R. Efficacy and Safety of Celiac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis in the Management of Abdominal Cancer Pain: A Meta-analysis of 359 Patients. Pain Physician. 2024 Jan;27(1):1-10.
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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.
Angela M Sousa, MD. PhD. study director
Instituto do Cancer do Estado de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splanchnic nerve neurolysis - 5 ml of absolute alcohol (100%) and Celiac Plexus Neurolysis - 5 ml of absolute alcohol (100%) in people with Cancer, Malignant Tumors and Abdominal Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 3 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: opening soon, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela M Sousa, MD. PhD. (+55 1198558-8339, angela.sousa@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAIN SCORE (time frame: 1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure). 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 NCT06978673, which also lists 9 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 3 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.