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

ConditionsPancreatic Cancer Non-resectableTumor PancreasPain Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis

    Procedure/Surgery

    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.

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysisActive comparator 1 intervention
Group B: Conventional step-up approachActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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