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Clinical Study on the Combination of Splanchnic Nerve Neurolysis with Anhydrous Ethanol and Implantable Intrathecal Drug Delivery System for the Treatment of Upper Abdominal Cancer Pain

Clinical Study on the Combination of Splanchnic Nerve Neurolysis with Anhydrous Ethanol and Implantable Intrathecal Drug Delivery System for the Treatment of Upper Abdominal Cancer Pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098991
Enrollment
Unknown
Registered
2025-03-17
Start date
2025-03-17
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer pain

Interventions

Systematic implantation with intrathecal drug infusion + splanchnic nerve block:Systematic implantation with intrathecal drug infusion + splanchnic nerve block.
Systematic implantation with intrathecal drug infusion:Systematic implantation with intrathecal drug infusion.

Sponsors

Shanghai East Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with upper abdominal malignancies (liver cancer, stomach cancer, pancreatic cancer, cholangiocarcinoma) who use opioids for analgesia; 2. Poor control of cancer pain, resting NRS>=4 points or eruption pain >=3 times a day, or inability to tolerate opioid side effects; 3. Opioid tolerance: Reduced responsiveness to opioids, requiring oral morphine > 60mg/ day or equivalent doses of other opioids to achieve the desired analgesic effect.

Exclusion criteria

Exclusion criteria: 1. Contraindications of intraspinal puncture; 2. Systemic infection or local infection of the surgical site; 3. Abnormal clotting and severe bleeding tendency; 4. The condition is serious and cannot tolerate cooperative surgery; 5. Allergic to the implanted catheter, pump and the drugs used in the pump; 6. Patients with cerebrospinal fluid circulation disorder due to intraspinal metastasis of tumor; 7. Severe mental illness; 8. Poor cognition or confusion; 9. Pregnant and lactating patients; 10. Unstable angina pectoris or cardiac obstruction in the past 6 months; Previous severe angina; Congestive heart failure; 11. The investigator determines that the subjects, including but not limited to major organ dysfunction and/or serious systemic diseases, are not suitable for participating in this clinical study; 12. Subarachnoid space injection of a single low dose of morphine hydrochloride test ineffective or serious adverse reactions.

Design outcomes

Primary

MeasureTime frame
NRS score;

Secondary

MeasureTime frame
Average number of pain outbreaks per day;Morphine dosage;Insomnia severity index;Survival rate;Incidence of opioid-related adverse reactions;Effect evaluation at 7 days after treatment;Incidence of postoperative complications;

Countries

China

Contacts

Public ContactLiao Lijun

Shanghai East Hospital

lliao@tongji.edu.cn+86 138 1742 8913

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026