Pancreatic Cancer Non-resectableNCT06160323
Upfront EUS CGN/CPN vs Conventional Step up Approach for Inoperable Painful Pancreatic Cancer
A study testing EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis in people with Pancreatic Cancer Non-resectable and Tumor Pancreas, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Non-resectable, Tumor Pancreas, Pain Cancer
- What is being tested?
- EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Nov 2023to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong, Hong Kong, 00000
Shannon M Chan, FRCS, 852-35052627, shannonchan@surgery.cuhk.edu.hk
About this study
Official title: Upfront Endoscopic Ultrasound-guided Celiac Ganglion Neurolysis Versus Conventional Step-up Approach for Patients With Painful, Inoperable 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.
- Being tested
- EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis
- Keywords
- Pancreatic Cancer Non-resectable, tumor pain, endoscopic ultrasound-guided celiac ganglion neurolysis
- Medical subject headings
- Pancreatic Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysisProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis | Active comparator | 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. Receives: Procedure: EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis |
| Conventional step-up approach | Active comparator | 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. Receives: Procedure: EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (12)
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)
Measured: 1 month
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)
Measured: 3 months
Short form McGill Pain Questionnaire-2
The absolute and mean percentage change in Short form McGill Pain Questionnaire-2
Measured: 3 months
Brief Pain Inventory
The absolute and mean percentage change in Brief Pain Inventory
Measured: 3 months
Morphine equivalent (MEQ) consumption
Absolute use and percentage change of morphine (expressed in morphine equivalent (MEQ) consumption) when compared to baseline
Measured: 3 months
Common opioid-related adverse effects
Common opioid-related adverse effects including nausea, pruritus, constipation and drowsiness will be recorded
Measured: 3 months
Quality of life
Changes of the score in quality of life (EORTC QLQ-C30)
Measured: 3 months
Karnofsky performance status
Karnofsky performance status at baseline, 4 weeks, 8 weeks and 12 weeks
Measured: 12 weeks
Adverse events from the EUS-guided CGN/CPN
Adverse events from the EUS-guided CGN/CPN will be recorded
Measured: 7 days
Breakthrough visits
Breakthrough visits in between the 4 weeks
Measured: 4 weeks
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
Measured: 3months
Overall survival
Date of death will be recorded
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start10 Nov 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Non-resectableStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient will be randomly assigned in a 1:1 ratio to either the upfront EUS-guided CGN/CPN approach or to the conventional step-up approach at the time of EUS. Site-specific block randomization will be performed via an online web-based randomization program with a concealed, fixed block size.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN SHANNON MELISSA, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160323
- Sponsor's protocol ID
- 2023.294
- Status last verified
- Apr 2026
- First submitted
- 29 Nov 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upfront Endoscopic Ultrasound-guided Celiac Ganglion Neurolysis Versus Conventional Step-up Approach for Patients With Painful, Inoperable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06160323
- Acronym / sponsor ID
- 2023.294
- Keywords
- Pancreatic Cancer Non-resectable, tumor pain, endoscopic ultrasound-guided celiac ganglion neurolysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patient will be randomly assigned in a 1:1 ratio to either the upfront EUS-guided CGN/CPN approach or to the conventional step-up approach at the time of EUS. Site-specific block randomization will be performed via an online web-based randomization program with a concealed, fixed block size.
| Arm | Type | Receives |
|---|---|---|
| EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis | Active comparator | Procedure: EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysisPatient 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. |
| Conventional step-up approach | Active comparator | Procedure: EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysisPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysisThe 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. | Procedure or surgery | Conventional step-up approach, EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis |
Primary outcome
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
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
Related trials for Pancreatic Cancer Non-resectable
RecruitingPhase 1
A Phase I Study of Intra-Arterial Yttrium-90 Radioembolization for Unresectable Pancreatic Cancer
Pancreatic Cancer Non-resectable
RecruitingObservational study
EUS Procedures Using RIVOS™ EUS Access Device
Pancreatic Fluid Collections, Biliary Obstruction
RecruitingPhase 2
Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer
Pancreatic Cancer Non-resectable, Pancreatic Cancer Metastatic
RecruitingObservational study
Pancreatic Cancer Detection Consortium
Pancreatic Cancer, Pancreatic Carcinoma
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided coeliac ganglion neurolysis / celiac plexus neurolysis in people with Pancreatic Cancer Non-resectable and Tumor Pancreas, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannon Melissa Chan (852-35052627, shannonchan@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in VAS pain score at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.