Chronic intractable abdominal/back pain inoperable abdominal malignancy chronische onhoudbare buik-/rugpijn inoperabele maligniteit in buik
Conditions
Interventions
Patients are randomized to undergo either endoscopic ultrasound-guided celiac ganglia neurolysis or percutaneous splanchnic nerve neurolysis.
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: • Diagnosis of an inoperable malignant tumor in the abdomen by histopathological or imaging findings. o Inoperable malignancy is defined as local tumor infiltration into surrounding organs, distant metastases or a poor general health due to serious concomitant disease. • Baseline pain score of ≥3 on a 11-point numeric rating scale (0-10) for upper abdominal or back pain. This is assessed on the three consecutive days prior to the procedure and the average score is used as a baseline pain score. • ≥18years old.
Exclusion criteria
Exclusion criteria: • Previous CPN • Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study • Coagulopathy (INR>1.5, platelets<50.000/mm3) which has not been corrected prior to the procedure • Pregnancy • Previous participation in this trial • Severe allergy to contrast • Systemic infection or infection at the location of the first lumbar vertebra. • Karnofsky performance scale of <30%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameter is the difference in short-term efficacy between P-SNN and EUS-CGN. •Pain is measured using a 11-point numeric rating scale (0-10) for upper abdominal or back pain. Pain is assessed after seven days, the patient is asked about the pain score with regard to the previous 24 hours. This is compared to the patients baseline pain score in order to determine the reduction in pain (=efficacy). •Baseline pain score is based on an assessment by the patient. The average pain score from the three consecutive days prior to the procedure will be used to determine the baseline pain score. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Pain reduction as a result of P-SNN compared to EUS-CGN, expressed as the percentage reduction in pain 7 days after the procedure. This will be compared to the average pain score of the three consecutive days prior to the procedure (=baseline pain score). • Long-term efficacy, assessed using the pain score at twelve weeks after the procedure. If a patient dies before this time, the last filled out pain score will be used. • Proportion of complete response (pain score ≤1, seven days after the neurolysis) between P-SNN and EUS-CGN. • Opioid usage pre- and post-neurolysis, converted to daily oral morphine equivalents. • Major complications related/not related to neurolysis procedure (either P-SNN or EUS-CGN); defined as complications leading to hospitalization, unintended prolongation of hospitalization, death or repeat (endoscopic) intervention with/without a possible or definite association with neurolysis procedure as determined by the treating physician. • Minor complications related/not related to neurolysis procedure; defined as minor complications with/without a possible or definite association with neurolysis procedure as determined by the treating physician. • Common opioid related side effects: nausea, pruritus, constipation, and drowsiness. • Side–effects of neurolysis; defined as transient diarrhea, back pain, pneumothorax or orthostatic hypotension up to 3 days post-neurolysis. • Technical success; successful injection of phenol at the correct location, as confirmed with fluoroscopy (in both groups). Judgment is made by the physician performing the procedure. • Experience of patients, assessed after the procedure in patients who were awake during the procedure. • EQ5D quality of life questionnaire prior to the procedure, a week, two weeks and four weeks after the procedure and then monthly up to 6 months. • Costs of both approaches. • Time required for both procedures. • Pain diary first week, diary evaluating side-effects first wee | — |
Contacts
Public ContactW.F.W. Kappelle
P.O. box 85500 University Medical Center Utrecht Department of Gastroenterology & Hepatology Room F02.618
Outcome results
None listed