Upfront EUS CGN/CPN vs Conventional Step up Approach for Inoperable Painful Pancreatic Cancer

Not Applicable

Recruiting

Interventions: Procedure: EUS-guided coeliac ganglion neurolysis / celiac plexus 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis	EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis	Patient would undergo a EUS diagnostic procedure with or without a biopsy. Patient would be blinded to the group they were assigned. The procedure will be performed with a linear array echoendoscope (EUS) under conscious sedation or monitored anaesthesia care. For cases in which celiac ganglia could not be visualized, EUS-guided coeliac plexus neurolysis (CPN) will be performed.
Conventional step-up approach	EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis	Patient would undergo a EUS diagnostic procedure with or without a biopsy. Patient would be blinded to the group they were assigned. The concept of the conventional step-up approach is to follow ESMO clinical practice guidelines for cancer pain. In case of inadequate pain control, the analgesics will be stepped up according to the guidelines. After 4 weeks, if patient's VAS score more than 7 or VAS score fails to improve by 20% despite optimal oral analgesics, patients are given the option of EUS-guided CGN/ CPN.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
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
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
Short form McGill Pain Questionnaire-2	3 months	The absolute and mean percentage change in Short form McGill Pain Questionnaire-2
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
Overall survival	48 weeks	Date of death will be recorded