Clinical trial NCT06160323: Upfront EUS CGN/CPN vs Conventional Step up Approach for Inoperable Painful Pancreatic Cancer
Official title: Upfront Endoscopic Ultrasound-guided Celiac Ganglion Neurolysis Versus Conventional Step-up Approach for Patients With Painful, Inoperable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer Non-resectable
Tumor Pancreas
Pain Cancer
Keywords: Pancreatic Cancer Non-resectable
tumor pain
endoscopic ultrasound-guided celiac ganglion neurolysis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient will be randomly assigned in a 1:1 ratio to either the upfront EUS-guided CGN/CPN approach or to the conventional step-up approach at the time of EUS. Site-specific block randomization will be performed via an online web-based randomization program with a concealed, fixed block size.
Primary purpose: TREATMENT

Brief summary: Patients with unresectable pancreatic cancer are often demoralized by intractable, persistent and incapacitating pain. It must be managed aggressively and strong opioids are recommended as the mainstay of treatment. However, patients develop opioid-related adverse effects. EUS-guided celiac plexus neurolysis (CPN) and celiac ganglion neurolysis (CGN) has been shown to provide high efficacy for pain control. The optimal timing, however, is in debate.


Eligibility criteria: Inclusion Criteria:

1. Age \>= 18 years old
2. Diagnosed to have inoperable pancreatic cancer
3. Presence of tumor pain (centrally located, constant, with no other obvious cause) with a VAS \>= 3
4. Karnofsky performance status \>= 60
5. Planned for EUS examination and/or biopsy of the pancreatic tumor

Exclusion Criteria:

1. Allergy to bupivacaine, or alcohol
2. Potentially operable after neoadjuvant therapy
3. Expected survival of less than 3 months
4. Patient who is already on opioids for pain control
5. Previous percutaneous or EUS-guided CGN/ CPN
6. Recurrent pancreatic tumors after operation
7. Uncorrectable coagulopathy
8. Inability or unwillingness to provide informed consent

Primary outcomes:
measure: The mean change in VAS pain score at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: The mean percentage and absolute change in VAS pain score at 1 month
timeFrame: 1 month
measure: The mean percentage in VAS pain score at 3 month
timeFrame: 3 months
measure: Short form McGill Pain Questionnaire-2
timeFrame: 3 months
measure: Brief Pain Inventory
timeFrame: 3 months
measure: Morphine equivalent (MEQ) consumption
timeFrame: 3 months
measure: Common opioid-related adverse effects
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: Karnofsky performance status
timeFrame: 12 weeks
measure: Adverse events from the EUS-guided CGN/CPN
timeFrame: 7 days
measure: Breakthrough visits
timeFrame: 4 weeks
measure: Need for and timing EUS-guided CGN/CPN for the conventional group
timeFrame: 3months
measure: Overall survival
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: