MalignancyPhase 4NCT04801082
Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain
A Phase 4 study testing Alcohol injection and Radiofrequency Ablation in people with Malignancy and Pain Management, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Many cancer patients suffer from intractable pain and which is often suboptimally controlled by even strong opioid analgesics. Coeliac plexus neurolysis (CPN) is procedure which intended to permanently destroy the nociceptive pathway that transmits the pain caused by the tumour. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancy, Pain Management
- What is being tested?
- Alcohol injection and Radiofrequency Ablation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2021to 31 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 year-old
- Patients who give informed consent to the study
- Suboptimal pain control with regular analgesics
- Inoperable cancer of pancreas, biliary system and liver (both primary or secondary)
Who cannot join
- Patients who refuse to give consent
- Patients aged <18 years
- EUS not possible due to:
- Problem related to scope insertion such as trismus, stenosis of the upper GI tract
- Coagulopathy with INR >1.5 or platelet count < 70
- Low oxygen saturation or extreme blood pressure render endoscopic procedure unsafe
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The University of Hong Kong
Hong Kong, 000000
Ka Wing Ma, MBBS, MS, +852 2255 3025, kawingma@hku.hk
About this study
Official title: Endoscopic Ultrasound-Guided Coeliac Plexus Neurolysis for Cancer Pain: Chemical Versus Radiofrequency Ablation
Many cancer patients suffer from intractable pain and which is often suboptimally controlled by even strong opioid analgesics. Coeliac plexus neurolysis (CPN) is procedure which intended to permanently destroy the nociceptive pathway that transmits the pain caused by the tumour. It can be with different approaches, such as percutaneously guided by fluoroscopy, echo-endoscopically or surgically with endoscopic approach being the more popular one in many centers equipped with echo-endoscopic services. The effect of CPN has been well established by some retrospective series. The overall response rate to CPN ranges from 70-90%, however, the analgesic effect is limited and up to roughly around 3 months. It is believed that the short-lasting analgesic effect is related to incomplete neurolysis by absolute alcohol injection.
Recently, radiofrequency ablation (RFA) of coeliac plexus has been introduced as another mode of CPN. So far, only one small single center randomized controlled trial (RCT) suggesting superior performance in favour to CPN using RFA. This result has to be validated and by a RCT with larger sample size. In addition, data concerning the quality of life (QOL) improvement and cost-effectiveness need to be further elucidated. Therefore, the aim of this study is to perform a RCT to look into these issues.
Read the detailed description
The aim of this study is to compare the efficacy of EUS-CPN by chemical ablation using alcohol injection versus by radiofrequency ablation in patients with cancer pain related to intra-abdominal malignancy. This is a randomised controlled trial to assess the clinical outcomes and cost-effectiveness of this new treatment approach.
- Conditions
- Malignancy, Pain Management
- Being tested
- Alcohol injection, Radiofrequency Ablation
- Keywords
- Endoscopic Ultrasound Guided, Radiofrequency Ablation, Coeliac plexus neurolysis, Intra-abdominal malignancy, Pain Relief, Chemical coeliac plexus neurolysis, Coeliac plexus ablation, Cancer pain
- Medical subject headings
- Neoplasms, Agnosia, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol injectionDrug
Also called Chemical Ablation
Chemical ablation is performed by injection of 10 mL of 0.25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol using a 22G FNA needle (Cook and Olympus)
Radiofrequency AblationDevice
Also called RFA
coeliac plexus is identified and punctured with 19G EUSRA RFA needle with 10W-30W of energy for 10-50s bilaterally or unilaterally depends on individual anatomical characteristics.
| Study group | Role | What they receive |
|---|---|---|
| EUS-CPB | Active comparator | Endoscopic Ultrasound Guided Coeliac Plexus Block Receives: Drug: Alcohol injection |
| EUS-CPA | Active comparator | Endoscopic Ultrasound Guided Coeliac Plexus Radiofrequency Ablation Receives: Device: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain score
change of pain score at 4th week after the procedure (by VAS score)
Measured: 4 weeks after the procedure
Secondary outcomes (13)
Change of pain score
change of pain score (Visual Analog Score) after the procedure
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Analgesic requirement
decrease in analgesic requirement
Measured: Up to 100 months (From the date of procedure until the date of death from any cause)
Technical success rate
technical success rate
Measured: 1 day
Clinical success rate
decrease in pain level by 30% from the pre-procedural baseline
Measured: Through study completion, an average of 2 year
Duration of procedure
time from injection of pre-medication to procedure last observation recording at the procedure suite
Measured: Up to 1 hour
Time to pain score drop by 50%
Time to Visual Analog Score drop by 50%
Measured: Through study completion, an average of 2 year
Short term complication rate
complication rate
Measured: Up to 1 week
Long term complication rate
complication rate
Measured: Through study completion, an average of 2 year
Hospital length of stay
Hospital length of stay
Measured: Up to 100 months
Health status (Quality of life)
The Short Form (36) Health Survey
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Quality of life (QOL) in patients with pancreatic cancer
PAN-26 questionnaire
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Quality of life (QOL) of cancer patients
QLQ-C30 questionnaire
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Cost-effectiveness
Total cost ($) of the treatment
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study startMar 2021 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by The 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ma Ka Wing, The University of Hong Kong
- Investigators
- Ka Wing Ma, MBBS, MS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801082
- Sponsor's protocol ID
- 202009185043
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-Guided Coeliac Plexus Neurolysis for Cancer Pain: Chemical Versus Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT04801082
- Acronym / sponsor ID
- 202009185043
- Conditions
- Malignancy, Pain Management
- Keywords
- Endoscopic Ultrasound Guided, Radiofrequency Ablation, Coeliac plexus neurolysis, Intra-abdominal malignancy, Pain Relief, Chemical coeliac plexus neurolysis, Coeliac plexus ablation, Cancer pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 16 Mar 2021 (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.
Many cancer patients suffer from intractable pain and which is often suboptimally controlled by even strong opioid analgesics. Coeliac plexus neurolysis (CPN) is procedure which intended to permanently destroy the nociceptive pathway that transmits the pain caused by the tumour. It can be with different approaches, such as percutaneously guided by fluoroscopy, echo-endoscopically or surgically with endoscopic approach being the more popular one in many centers equipped with echo-endoscopic services. The effect of CPN has been well established by some retrospective series. The overall response rate to CPN ranges from 70-90%, however, the analgesic effect is limited and up to roughly around 3 months. It is believed that the short-lasting analgesic effect is related to incomplete neurolysis by absolute alcohol injection.
Recently, radiofrequency ablation (RFA) of coeliac plexus has been introduced as another mode of CPN. So far, only one small single center randomized controlled trial (RCT) suggesting superior performance in favour to CPN using RFA. This result has to be validated and by a RCT with larger sample size. In addition, data concerning the quality of life (QOL) improvement and cost-effectiveness need to be further elucidated. Therefore, the aim of this study is to perform a RCT to look into these issues.
Detailed description
The aim of this study is to compare the efficacy of EUS-CPN by chemical ablation using alcohol injection versus by radiofrequency ablation in patients with cancer pain related to intra-abdominal malignancy. This is a randomised controlled trial to assess the clinical outcomes and cost-effectiveness of this new treatment approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-CPB | Active comparator | Drug: Alcohol injectionEndoscopic Ultrasound Guided Coeliac Plexus Block |
| EUS-CPA | Active comparator | Device: Radiofrequency AblationEndoscopic Ultrasound Guided Coeliac Plexus Radiofrequency Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 year-old
- Patients who give informed consent to the study
- Suboptimal pain control with regular analgesics
- Inoperable cancer of pancreas, biliary system and liver (both primary or secondary)
Key exclusion criteria (6 listed)
- Patients who refuse to give consent
- Patients aged <18 years
- EUS not possible due to:
- Problem related to scope insertion such as trismus, stenosis of the upper GI tract
- Coagulopathy with INR >1.5 or platelet count < 70
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 |
|---|---|---|
| Alcohol injectionAlso: Chemical AblationChemical ablation is performed by injection of 10 mL of 0.25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol using a 22G FNA needle (Cook and Olympus) | Drug | EUS-CPB |
| Radiofrequency AblationAlso: RFAcoeliac plexus is identified and punctured with 19G EUSRA RFA needle with 10W-30W of energy for 10-50s bilaterally or unilaterally depends on individual anatomical characteristics. | Device | EUS-CPA |
Primary outcome
Change of pain score
Time frame: 4 weeks after the procedure
change of pain score at 4th week after the procedure (by VAS score)
13 secondary outcomes
Change of pain score
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Analgesic requirement
Time frame: Up to 100 months (From the date of procedure until the date of death from any cause)
Technical success rate
Time frame: 1 day
Clinical success rate
Time frame: Through study completion, an average of 2 year
Duration of procedure
Time frame: Up to 1 hour
Time to pain score drop by 50%
Time frame: Through study completion, an average of 2 year
Short term complication rate
Time frame: Up to 1 week
Long term complication rate
Time frame: Through study completion, an average of 2 year
Hospital length of stay
Time frame: Up to 100 months
Health status (Quality of life)
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Quality of life (QOL) in patients with pancreatic cancer
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Quality of life (QOL) of cancer patients
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Cost-effectiveness
Time frame: Through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
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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. This study is not recruiting at the moment.
Ka Wing Ma, MBBS, MS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alcohol injection and Radiofrequency Ablation in people with Malignancy and Pain Management, run by The 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Mar 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan Yee Chiu, BISC (+852 2255 4848, krissy23@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain score (time frame: 4 weeks after the procedure). 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 22 Mar 2021.