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Recruiting NCT06160323

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

No phase Interventional Pancreatic Cancer Non-resectable Tumor Pancreas Pain Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis.
Who it may be relevant to
Registry conditions: Pancreatic Cancer Non-resectable, Tumor Pancreas, Pain Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • The mean change in VAS pain score at 3 months [Time frame: 3 months]
Secondary outcome measures (12)
  • The mean percentage and absolute change in VAS pain score at 1 month [Time frame: 1 month]
  • The mean percentage in VAS pain score at 3 month [Time frame: 3 months]
  • Short form McGill Pain Questionnaire-2 [Time frame: 3 months]
  • Brief Pain Inventory [Time frame: 3 months]
  • Morphine equivalent (MEQ) consumption [Time frame: 3 months]
  • Common opioid-related adverse effects [Time frame: 3 months]
  • Quality of life [Time frame: 3 months]
  • Karnofsky performance status [Time frame: 12 weeks]
  • Adverse events from the EUS-guided CGN/CPN [Time frame: 7 days]
  • Breakthrough visits [Time frame: 4 weeks]
  • Need for and timing EUS-guided CGN/CPN for the conventional group [Time frame: 3months]
  • Overall survival [Time frame: 48 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital — Hong Kong

Identifiers

NCT: NCT06160323 · 2023.294

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗