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

Pancreatic Cancer Non-resectable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06160323
• Other study ID #: 2023.294
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: November 2023
• Source: Chinese University of Hong Kong
• Contact: Shannon Melissa Chan
• Phone: 852-35052627
• Email: shannonchan[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain Cancer
• Pancreatic Cancer Non-resectable
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Short form McGill Pain Questionnaire-2	The absolute and mean percentage change in Short form McGill Pain Questionnaire-2	3 months
Secondary	Brief Pain Inventory	The absolute and mean percentage change in Brief Pain Inventory	3 months
Secondary	Morphine equivalent (MEQ) consumption	Absolute use and percentage change of morphine (expressed in morphine equivalent (MEQ) consumption) when compared to baseline	3 months
Secondary	Common opioid-related adverse effects	Common opioid-related adverse effects including nausea, pruritus, constipation and drowsiness will be recorded	3 months
Secondary	Quality of life	Changes of the score in quality of life (EORTC QLQ-C30)	3 months
Secondary	Karnofsky performance status	Karnofsky performance status at baseline, 4 weeks, 8 weeks and 12 weeks	12 weeks
Secondary	Adverse events from the EUS-guided CGN/CPN	Adverse events from the EUS-guided CGN/CPN will be recorded	7 days
Secondary	Breakthrough visits	Breakthrough visits in between the 4 weeks	4 weeks
Secondary	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
Secondary	Overall survival	Date of death will be recorded	48 weeks