Pain Cancer, Pancreatic Cancer Non-resectable, Tumor Pancreas
Conditions
Keywords
Pancreatic Cancer Non-resectable, tumor pain, endoscopic ultrasound-guided celiac ganglion neurolysis
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.
Interventions
PROCEDUREEUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis
The EUS scope was first inserted into the stomach, and the coeliac trunk was visualized by scanning from the lesser curve of the gastric body. After visualization, the scope was rotated clockwise, enabling visualization and identification of the left adrenal gland. The coeliac ganglia are often seen to the left of the coeliac artery, between the aorta and the left adrenal gland, at the level between the coeliac artery and the left adrenal artery. They are also visualized cephalad to the coeliac artery in some cases. Hypoechoic nodular structures linked by hypoechoic threads residing in the periphery of this region were defined as the coeliac ganglia . A 19G or 22G needle was used for puncture of the CGN. After confirming the lack of backflow of blood with aspiration, a mixture of 5ml of 0.25-0.5% bupivacaine and 5ml absolute alcohol was injected. For cases in which celiac ganglia could not be visualized, EUS-guided coeliac plexus neurolysis (CPN) will be performed.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patient will be masked on their randomization until (i) 3 month from randomization (study endpoint) or (ii) after 4 weeks if VAS score \>= 7 or VAS score fails to improve by 20% despite optimal oral analgesics, when they will be allowed to opt for EUS-guided CGN/ CPN. The pain assessment will be performed by assessors who are blinded to the randomized group each time.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The mean change in VAS pain score at 3 months | 3 months | The mean change in VAS pain score at 3 months when compared to baseline (pre-procedure) between upfront EUS group and conventional step-up group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The mean percentage and absolute change in VAS pain score at 1 month | 1 month | The mean percentage and absolute change in VAS pain score at 1 month when compared to baseline (pre-procedure) |
| The mean percentage in VAS pain score at 3 month | 3 months | The mean percentage in VAS pain score at 3 month when compared to baseline (pre-procedure) |
| Short form McGill Pain Questionnaire-2 | 3 months | The absolute and mean percentage change in Short form McGill Pain Questionnaire-2 |
| Brief Pain Inventory | 3 months | The absolute and mean percentage change in Brief Pain Inventory |
| Morphine equivalent (MEQ) consumption | 3 months | Absolute use and percentage change of morphine (expressed in morphine equivalent (MEQ) consumption) when compared to baseline |
| Common opioid-related adverse effects | 3 months | Common opioid-related adverse effects including nausea, pruritus, constipation and drowsiness will be recorded |
| Quality of life | 3 months | Changes of the score in quality of life (EORTC QLQ-C30) |
| Karnofsky performance status | 12 weeks | Karnofsky performance status at baseline, 4 weeks, 8 weeks and 12 weeks |
| Adverse events from the EUS-guided CGN/CPN | 7 days | Adverse events from the EUS-guided CGN/CPN will be recorded |
| Breakthrough visits | 4 weeks | Breakthrough visits in between the 4 weeks |
| Need for and timing EUS-guided CGN/CPN for the conventional group | 3months | Need for and timing EUS-guided CGN/CPN for the conventional group will be recorded |
| Overall survival | 48 weeks | Date of death will be recorded |
Countries
Hong Kong
Contacts
CONTACTShannon Melissa Chan
Outcome results
None listed