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

NCT06160323 | Recruiting DMC

• 1 other identifier: 2023.294
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer Non-resectable; Tumor Pancreas; Pain Cancer

Keywords

Pancreatic Cancer Non-resectable; tumor pain; endoscopic ultrasound-guided celiac ganglion neurolysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• The mean percentage and absolute change in VAS pain score at 1 month

  1 month

• The mean percentage in VAS pain score at 3 month

  3 months

• Short form McGill Pain Questionnaire-2

  3 months

• Brief Pain Inventory

  3 months

• Morphine equivalent (MEQ) consumption

  3 months

Study Arms (2)

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.

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

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.

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

Interventions

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.

Conventional step-up approach; EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergy to bupivacaine, or alcohol
• Potentially operable after neoadjuvant therapy
• Expected survival of less than 3 months
• Patient who is already on opioids for pain control
• Previous percutaneous or EUS-guided CGN/ CPN
• Recurrent pancreatic tumors after operation
• Uncorrectable coagulopathy
• Inability or unwillingness to provide informed consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, 00000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Cancer Pain

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shannon Melissa Chan

CONTACT

852-35052627; shannonchan@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: November 10, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

HK (1)