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

Upfront Endoscopic Ultrasound-guided Celiac Ganglion Neurolysis Versus Conventional Step-up Approach for Patients With Painful, Inoperable Pancreatic Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer Non-resectable; Pain Cancer; Tumor Pancreas
• Intervention / Treatment: Procedure: EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shannon Melissa Chan; Phone Number: 852-35052627; Email: shannonchan@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 00000
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Shannon M Chan, FRCS; Phone Number: 852-35052627; Email: shannonchan@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: EUS-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.
Active Comparator: Conventional step-up approach; 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.	Procedure: EUS-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pancreatic Cancer Non-resectable; tumor pain; endoscopic ultrasound-guided celiac ganglion neurolysis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 2023.294

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No