Percutaneous splachnic nerve neurolysis vs. endoscopic ultrasound-guided celiac ganglia neurolysis

Completed

Conditions: cancer
intra-abdominal malignancy
10017990

Registration Number: NL-OMON41507

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 94

Inclusion Criteria

• Diagnosis of an inoperable malignant tumor in the upper 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 >=4 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.
• >17 years old.

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 11th thoracic vertebra
• Karnofsky performance scale of <30%

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary parameter is the difference in short-term efficacy between P-SNN<br /><br>and EUS-CGN.<br /><br>• Pain is measured using a 11-point numeric rating scale (0-10) for upper<br /><br>abdominal or back pain, due to an inoperable intra-abdominal malignancy. The<br /><br>pain score used to determine the primary outcome will be assessed seven days<br /><br>after the procedure. This is compared to the patients baseline pain score in<br /><br>order to determine the reduction in pain (=efficacy).<br /><br>• Baseline pain score is based on an assessment by the patient. The average<br /><br>pain score from the three consecutive days prior to the procedure will be used<br /><br>to determine the baseline pain score. </p><br>

Secondary Outcome Measures