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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Pancreatic Cancer Non-resectable; Pain Cancer; Tumor Pancreas

Treatments: Procedure: EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT06160323

2023.294

Details and patient eligibility

About

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis

Active Comparator group

Description:

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.

Treatment:

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

Conventional step-up approach

Active Comparator group

Description:

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.

Treatment:

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