Refractory abdominal pain associated with advanced malignancy, especially upper abdominal or retroperitoneal pain related to celiac plexus involvement
Conditions
Interventions
CT-guided percutaneous celiac plexus radiofrequency ablation group:CT-guided percutaneous celiac plexus radiofrequency ablation
Celiac plexus radiotherapy group:In the celiac plexus radiotherapy (CPRS) group, treatment consisted of a single or multiple fractions of 25 Gy stereotactic body radiotherapy (SBRT)
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age greater than 18 years. 2.Histologically or cytologically confirmed metastatic or unresectable malignancy. 3.Presence of severe retroperitoneal pain syndrome consistent with celiac plexus involvement, characterized by at least one of the following: pain mainly located in the upper abdomen or subxiphoid region with radiation to the back or lower back; band-like, deep dull pain or persistent aching pain; or pain distribution judged by the investigator to be consistent with celiac plexus or retroperitoneal pain syndrome; 4.Radiological evidence, such as contrast-enhanced CT or MRI, confirming anatomical involvement of the celiac plexus, including pancreatic cancer, or other malignancies with imaging evidence of direct tumor invasion of the celiac vessels or celiac plexus, or blurred soft-tissue changes around the celiac vessels suggesting tumor encasement. 5.Persistent pain score >=5 according to the Brief Pain Inventory-Short Form (BPI-SF) despite regular analgesic treatment. 6.ECOG performance status score of 0–2. 7.Expected survival longer than 3 months. 8.No prior history of celiac plexus radiotherapy. 9.No prior successful celiac plexus block or neurolytic/destructive treatment. 10.Voluntary participation in the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Known contraindication to any medication or radiotherapy regimen used in this study. 2.Severe coagulation dysfunction or uncorrectable bleeding tendency, defined as any of the following: platelet count 1.5; or APTT >1.5 times the upper limit of normal. 3.Infection in the celiac plexus region. 4.Pregnant or lactating women. 5.Patients who are unable to understand the study, independently provide informed consent, or comply with treatment and follow-up; patients suspected of cognitive impairment will be screened using Mini-Cog, and those with a score <3 will not be enrolled. 6.Pain not primarily caused by celiac plexus involvement, such as bone metastasis or intestinal obstruction. 7.Prior celiac plexus surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score;Incidence of adverse events;Opioid consumption;Duration of pain response;Complete pain response rate; | — |
Countries
China
Contacts
Public ContactFang fang
Zhongshan Hospital, Fudan University
Outcome results
None listed