Clinical trial · Interventional
Outcomes of Fluoroscopy-Guided Transdiscal Splanchnic Nerve Neurolysis for Upper Abdominal Cancer Pain.
Clinical Outcomes and Safety of Fluoroscopy-Guided Transdiscal Splanchnic Nerve Neurolysis in Patients With Upper Abdominal Cancer Pain: A Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
The goal of this prospective study is to learn whether fluoroscopy-guided transdiscal splanchnic nerve neurolysis can safely reduce severe upper abdominal cancer pain in adults with pancreatic, gastric, or hepatobiliary cancer. The study will also assess whether this procedure can reduce the need for opioid pain medicines and improve patients' functional status and quality of life. The main questions it aims to answer are: Does the procedure reduce patients' pain one month after treatment? Does it reduce the amount of opioid pain medication patients need? Does it improve functional status and quality of life? What complications or side effects occur after the procedure? How long does pain relief last, and how often is repeat treatment needed? Participants will: First receive a diagnostic splanchnic nerve block with local anesthetic. If the diagnostic block provides at least 50% pain relief, undergo transdiscal splanchnic nerve neurolysis using fluoroscopy guidance. Receive a neurolytic agent (absolute alcohol or phenol) through a needle placed at the T11-T12 or T12-L1 level. Have their pain, opioid medication use, functional status, complications, and satisfaction assessed before treatment and during follow-up. Complete follow-up assessments at 1 week, 1 month, 3 months, and 6 months after the procedure. Complete a quality-of-life questionnaire before treatment and at 1 month. The primary outcome will be the change in pain score on the 0-10 Numeric Rating Scale at 1 month after the procedure.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Hepatobiliary Cancer | Malignant Hepatobiliary Neoplasm | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Upper Abdominal Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemical Neurolysis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemical Neurolysis
- description
- Participant will undergo chemical neurolysis using the study specified neurolytic agent for management of chronic pain. the intervention will be administered according to study protocol, with participant followed prospectively for pain relief and treatment related outcomes
- interventionNames
- Procedure: Chemical Neurolysis
Primary outcomes (1)
- measure
- Change in pain intensity
- timeFrame
- Baseline to 1 month after the procedure
- description
- Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents the worst imaginable pain. The change in NRS pain score from baseline will be assessed following fluoroscopy-guided transdiscal splanchnic nerve neurolysis.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. Confirmed diagnosis of pancreatic, gastric, or hepatobiliary malignancy with epigastric/upper abdominal pain. Baseline NRS ≥ 7 despite optimized pharmacotherapy, or intolerable opioid side effects. ≥ 50% pain relief on diagnostic splanchnic nerve block. Able to provide informed consent. Exclusion Criteria: * Coagulopathy (INR \> 1.5, platelets \< 50,000/µL). Local or systemic infection. Uncontrolled hypotension or severe cardiopulmonary compromise precluding prone positioning. Intestinal obstruction. Known allergy to contrast, local anesthetic, or the neurolytic agent. Patient refusal.
References
Publications (13)
- BACKGROUNDvon Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ. 2007 Oct 20;335(7624):806-8. doi: 10.1136/bmj.39335.541782.AD. PMID 17947786
- BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
- BACKGROUNDGoyal S, Kumar A, Goyal D, Attar P, Bhandari B, Purohit G, Mahiswar AP, Gupta S. Efficacy of splanchnic nerve neurolysis in the management of upper abdominal cancer pain: A systematic review and meta-analysis. Indian J Anaesth. 2023 Dec;67(12):1036-1050. doi: 10.4103/ija.ija_439_23. Epub 2023 Dec 13. PMID 38343676
- BACKGROUNDLuo L, Cao X, Qiu M, Zhu M, Yan Y, Zhang D, Zhang X. Splanchnic nerve block via transdiscal and paraspinal approach in the treatment of pain in advanced pancreatic cancer: A randomized controlled trial. Medicine (Baltimore). 2025 Sep 19;104(38):e44250. doi: 10.1097/MD.0000000000044250. PMID 40988238
- BACKGROUNDYanaizumi R, Nagamine Y, Harada S, Kuramochi T, Ota S, Abe Y, Nakagawa M, Kamijima K, Hayashi M, Tazawa T, Ogawa K, Goto T. Efficacy and Safety of Neurolytic Splanchnic Nerve Block via Transintervertebral Disc Approach to Retrocrural Space: A Multicenter Retrospective Study. Pain Ther. 2022 Dec;11(4):1359-1372. doi: 10.1007/s40122-022-00432-7. Epub 2022 Sep 28. PMID 36169799
- BACKGROUNDCai Z, Zhou X, Wang M, Kang J, Zhang M, Zhou H. Splanchnic nerve neurolysis via the transdiscal approach under fluoroscopic guidance: a retrospective study. Korean J Pain. 2022 Apr 1;35(2):202-208. doi: 10.3344/kjp.2022.35.2.202.