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RecruitingNCT06160323Updated May 6, 2026

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

An interventional study of EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis in Pancreatic Cancer Non-resectable, Tumor Pancreas and Pain Cancer, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pancreatic Cancer Non-resectable
  • Tumor Pancreas
  • Pain Cancer

Keywords

  • Pancreatic Cancer Non-resectable
  • tumor pain
  • endoscopic ultrasound-guided celiac ganglion neurolysis
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 94 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
94 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureEUS-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.

06

What researchers measure

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

    Time frame: 3 months

Secondary outcomes

  1. 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)

    Time frame: 1 month

  2. 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)

    Time frame: 3 months

  3. Short form McGill Pain Questionnaire-2

    The absolute and mean percentage change in Short form McGill Pain Questionnaire-2

    Time frame: 3 months

  4. Brief Pain Inventory

    The absolute and mean percentage change in Brief Pain Inventory

    Time frame: 3 months

  5. Morphine equivalent (MEQ) consumption

    Absolute use and percentage change of morphine (expressed in morphine equivalent (MEQ) consumption) when compared to baseline

    Time frame: 3 months

  6. Common opioid-related adverse effects

    Common opioid-related adverse effects including nausea, pruritus, constipation and drowsiness will be recorded

    Time frame: 3 months

  7. Quality of life

    Changes of the score in quality of life (EORTC QLQ-C30)

    Time frame: 3 months

  8. Karnofsky performance status

    Karnofsky performance status at baseline, 4 weeks, 8 weeks and 12 weeks

    Time frame: 12 weeks

  9. Adverse events from the EUS-guided CGN/CPN

    Adverse events from the EUS-guided CGN/CPN will be recorded

    Time frame: 7 days

  10. Breakthrough visits

    Breakthrough visits in between the 4 weeks

    Time frame: 4 weeks

  11. 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

    Time frame: 3months

  12. Overall survival

    Date of death will be recorded

    Time frame: 48 weeks

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06160323
Lead sponsor
Chinese University of Hong Kong
Responsible party
CHAN SHANNON MELISSA (Assistant Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Dec 7, 2023
Start date
Nov 10, 2023
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
May 6, 2026

Study contacts

Shannon Melissa Chan
Contact
shannonchan@surgery.cuhk.edu.hk
852-35052627

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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