Upfront EUS CGN/CPN vs Conventional Step up Approach for Inoperable Painful Pancreatic Cancer
NCT ID: NCT06160323
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
94 participants
INTERVENTIONAL
2023-11-10
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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 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
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.
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 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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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CHAN SHANNON MELISSA
Assistant Professor
Locations
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Prince of Wales Hospital
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Shannon M Chan, FRCS
Role: primary
Other Identifiers
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2023.294
Identifier Type: -
Identifier Source: org_study_id