Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change in VAS pain score at 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The mean percentage and absolute change in VAS pain score at 1 month | The mean percentage and absolute change in VAS pain score at 1 month when compared to baseline (pre-procedure) | 1 month |
| The mean percentage in VAS pain score at 3 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shannon Melissa Chan | Contact | 852-35052627 | shannonchan@surgery.cuhk.edu.hk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Recruiting | Hong Kong | Hong Kong | 00000 | Hong Kong |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
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.
Not provided
Not provided
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.
|
The mean percentage in VAS pain score at 3 month when compared to baseline (pre-procedure)
| 3 months |
| Short form McGill Pain Questionnaire-2 | The absolute and mean percentage change in Short form McGill Pain Questionnaire-2 | 3 months |
| Brief Pain Inventory | The absolute and mean percentage change in Brief Pain Inventory | 3 months |
| Morphine equivalent (MEQ) consumption | Absolute use and percentage change of morphine (expressed in morphine equivalent (MEQ) consumption) when compared to baseline | 3 months |
| Common opioid-related adverse effects | Common opioid-related adverse effects including nausea, pruritus, constipation and drowsiness will be recorded | 3 months |
| Quality of life | Changes of the score in quality of life (EORTC QLQ-C30) | 3 months |
| Karnofsky performance status | Karnofsky performance status at baseline, 4 weeks, 8 weeks and 12 weeks | 12 weeks |
| Adverse events from the EUS-guided CGN/CPN | Adverse events from the EUS-guided CGN/CPN will be recorded | 7 days |
| Breakthrough visits | Breakthrough visits in between the 4 weeks | 4 weeks |
| Need for and timing EUS-guided CGN/CPN for the conventional group | Need for and timing EUS-guided CGN/CPN for the conventional group will be recorded | 3months |
| Overall survival | Date of death will be recorded | 48 weeks |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |