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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41507

Enrollment

Registered

2014-04-28

Start date

2014-06-17

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

cancer intra-abdominal malignancy

Interventions

Patients are randomized to undergo either endoscopic ultrasound-guided celiac ganglia neurolysis or percutaneous splanchnic nerve neurolysis.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

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, due to an inoperable intra-abdominal malignancy. The pain score used to determine the primary outcome will be assessed seven days after the procedure. 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.	—

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, due to an inoperable intra-abdominal malignancy. The pain score used to determine the primary outcome will be assessed seven days after the procedure. 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.

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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. • Difference in complete response (pain score	—

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. • Difference in complete response (pain score

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)