Cancer of PancreasPhase 4NCT04809935
EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy
A Phase 4 study testing 98% dehydrated alcohol and 19G EUSRA needle, Taewoong Medical, Korea in people with Cancer of Pancreas and Pancreatic Neoplasms, 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
- Cancer of Pancreas, Pancreatic Neoplasms, Pain
- What is being tested?
- 98% dehydrated alcohol and 19G EUSRA needle, Taewoong Medical, Korea
- 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
- 21 Sep 2020to 31 Jan 2024
- 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
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, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, 000000
Wan Yee Chiu, BISC, +852 2255 4848, krissy23@hku.hk
Ka Wing Ma, MBBS, MS
About this study
Official title: Endoscopic Ultrasound Guided Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Intractable Pain Due to Malignancy A Randomized Controlled Study
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-guided CPN versus radiofrequency ablation in patients with pain related to pancreatic cancer. By performing a randomized controlled trial, the clinical outcomes and cost-effectiveness of this new RFA treatment approach can be evaluated.
- Being tested
- 98% dehydrated alcohol, 19G EUSRA needle, Taewoong Medical, Korea
- Keywords
- Endoscopic Ultrasound Guided, Radiofrequency Ablation, Coeliac plexus neurolysis, Pancreatic cancer, Pain Relief, Chemical coeliac plexus neurolysis, Coeliac plexus ablation, Cancer pain
- Medical subject headings
- Pancreatic Neoplasms, Pain, Cancer Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
98% dehydrated alcoholDrug
Also called Chemical Ablation
- coeliac plexus is identified and punctured
- Injection of 10 mL of .25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol.
19G EUSRA needle, Taewoong Medical, KoreaDevice
- 10W-30W RFA will be applied unilaterally or bilaterally depends on individual anatomical characteristics for 10-50s
- Complete ablation of coeliac plexus nervous tissue is confirmed by appearance of air-bubble ultrasound scan
| Study group | Role | What they receive |
|---|---|---|
| EUS-CPB | Active comparator | Chemical ablation of the coeliac plexus Receives: Drug: 98% dehydrated alcohol |
| EUS-CPA | Active comparator | Radiofrequency ablation of the coeliac plexus Receives: Device: 19G EUSRA needle, Taewoong Medical, Korea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain score at 4 weeks after procedure (by VAS score)
Measured: 4 weeks
Secondary outcomes (11)
Technical success rate
Technical success rate
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Clinical success rate
Decrease of pain level by 30% from pre-procedural baseline
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
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 of two types approach
Total cost ($) of 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 posted22 Mar 2021
- Study start21 Sep 2020
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies 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
- NCT04809935
- Sponsor's protocol ID
- 204610401
- Status last verified
- Mar 2021
- First submitted
- 10 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 Block Versus Radiofrequency Ablation in Pain Relief of Patients With Intractable Pain Due to Malignancy A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04809935
- Acronym / sponsor ID
- 204610401
- Keywords
- Endoscopic Ultrasound Guided, Radiofrequency Ablation, Coeliac plexus neurolysis, Pancreatic cancer, 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
- 21 Sep 2020 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 22 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-guided CPN versus radiofrequency ablation in patients with pain related to pancreatic cancer. By performing a randomized controlled trial, the clinical outcomes and cost-effectiveness of this new RFA treatment approach can be evaluated.
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: 98% dehydrated alcoholChemical ablation of the coeliac plexus |
| EUS-CPA | Active comparator | Device: 19G EUSRA needle, Taewoong Medical, KoreaRadiofrequency ablation of the coeliac plexus |
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
Key exclusion criteria (5 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
- Low oxygen saturation or extreme blood pressure render endoscopic procedure unsafe
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 |
|---|---|---|
| 98% dehydrated alcoholAlso: Chemical Ablation* coeliac plexus is identified and punctured * Injection of 10 mL of .25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol. | Drug | EUS-CPB |
| 19G EUSRA needle, Taewoong Medical, Korea* 10W-30W RFA will be applied unilaterally or bilaterally depends on individual anatomical characteristics for 10-50s * Complete ablation of coeliac plexus nervous tissue is confirmed by appearance of air-bubble ultrasound scan | Device | EUS-CPA |
Primary outcome
Pain score
Time frame: 4 weeks
Pain score at 4 weeks after procedure (by VAS score)
11 secondary outcomes
Technical success rate
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Clinical success rate
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
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 of two types approach
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 98% dehydrated alcohol and 19G EUSRA needle, Taewoong Medical, Korea in people with Cancer of Pancreas and Pancreatic Neoplasms, 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 5 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?
Pain score (time frame: 4 weeks). 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.