Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: COELIAC PLEXUS NEUROLYSIS FOR PAIN RELIEF IN ADVANCED CANCER: NEUROLYSIS OF COELIAC PLEXUS WITH 99% ETHYL ALCOHOL,FOR PAIN RELIEF IN ADVANCED MALIGNANCY
Control Intervention1: SINGLE FR
Sponsors
DR BRA INSTITUTE CANCER ROTARY HOSPITAL
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients aged 18 years and above. Diagnosis of upper gastrointestinal malignancy with abdominal pain. Experiencing pain that is refractory to standard analgesic management, defined as an average pain intensity score of more than or equals to 5 on a 0 to 10 Numerical Rating Scale or equivalent on the Brief Pain Inventory Short Form over the past week despite optimised analgesic therapy. Ability to provide informed consent to participate in the study. Willingness to comply with study procedures and follow up visits. Eastern Cooperative Oncology Group physical status classification less than or equal to III.
Exclusion criteria
Exclusion criteria: Patients with contraindications to celiac plexus neurolysis or celiac plexus radio surgery. Prior celiac plexus neurolytic procedure or celiac plexus irradiation. History of severe cardiac disease, including significant arrhythmias, heart block, or severe heart failure. Coagulopathy or bleeding disorders. Inability to provide informed consent or comply with study procedures. Infection at needle insertion site. Eastern Cooperative Oncology Group PS more than or equal to IV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the change in average pain intensity from baseline to 6 weeks post-intervention, as measured by the Brief Pain Inventory Short Form, between patients with advanced cancer receiving celiac plexus neurolysis and those receiving single fraction stereotactic body radiation therapy to celiac plexus.Timepoint: BASELINE TWO, FOUR, SIX WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the change in worst pain intensity from baseline to fortnightly till 6 weeks post-intervention, as measured by the BPI-SF, between the two treatment groups.Timepoint: BASELINE TWO, FOUR, SIX WEEKS;To compare the change in opioid consumption (measured as morphine equivalent daily dose) from baseline to fortnightly till 6 weeks post-intervention between the two treatment groups.Timepoint: BASELINE TWO, FOUR, SIX WEEKS;To compare the change in quality of life from baseline to 6 weeks post-intervention, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), between the two treatment groups.Timepoint: BASELINE SIX WEEKS;To compare the incidence and severity of adverse events related to each intervention within the first 6 weeks post-procedure.Timepoint: BASELINE TWO, FOUR, SIX WEEKS;To compare overall patient satisfaction with the procedure.Timepoint: BASELINE SIX WEEKS | — |
Countries
India
Contacts
Public ContactDR NISHKARSH GUPTA
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
Outcome results
None listed