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NCT Number: NCT06160323

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

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Key information

Conditions

Pancreatic Cancer Non-resectable Cancer Pain Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain Cancer Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Tumor Pancreas

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. The mean change in VAS pain score at 3 months

    Time frame: 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

Secondary outcomes

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

    Time frame: 1 month

    The mean percentage and absolute change in VAS pain score at 1 month when compared to baseline (pre-procedure)

  2. The mean percentage in VAS pain score at 3 month

    Time frame: 3 months

    The mean percentage in VAS pain score at 3 month when compared to baseline (pre-procedure)

  3. Short form McGill Pain Questionnaire-2

    Time frame: 3 months

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

  4. Brief Pain Inventory

    Time frame: 3 months

    The absolute and mean percentage change in Brief Pain Inventory

  5. Morphine equivalent (MEQ) consumption

    Time frame: 3 months

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

  6. Common opioid-related adverse effects

    Time frame: 3 months

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

  7. Quality of life

    Time frame: 3 months

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

  8. Karnofsky performance status

    Time frame: 12 weeks

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

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

    Time frame: 7 days

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

  10. Breakthrough visits

    Time frame: 4 weeks

    Breakthrough visits in between the 4 weeks

  11. Need for and timing EUS-guided CGN/CPN for the conventional group

    Time frame: 3months

    Need for and timing EUS-guided CGN/CPN for the conventional group will be recorded

  12. Overall survival

    Time frame: 48 weeks

    Date of death will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Shannon Melissa Chan

CONTACT

[email protected]

852-35052627

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Dec 7, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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