Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain
Primary Purpose
Malignancy, Pain Management
Status
Not yet recruiting
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Alcohol injection
Radiofrequency Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Malignancy focused on measuring Endoscopic Ultrasound Guided, Radiofrequency Ablation, Coeliac plexus neurolysis, Intra-abdominal malignancy, Pain Relief, Chemical coeliac plexus neurolysis, Coeliac plexus ablation, Cancer pain
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
EUS-CPB
EUS-CPA
Arm Description
Endoscopic Ultrasound Guided Coeliac Plexus Block
Endoscopic Ultrasound Guided Coeliac Plexus Radiofrequency Ablation
Outcomes
Primary Outcome Measures
Change of pain score
change of pain score at 4th week after the procedure (by VAS score)
Secondary Outcome Measures
Change of pain score
change of pain score (Visual Analog Score) after the procedure
Analgesic requirement
decrease in analgesic requirement
Technical success rate
technical success rate
Clinical success rate
decrease in pain level by 30% from the pre-procedural baseline
Duration of procedure
time from injection of pre-medication to procedure last observation recording at the procedure suite
Time to pain score drop by 50%
Time to Visual Analog Score drop by 50%
Short term complication rate
complication rate
Long term complication rate
complication rate
Hospital length of stay
Hospital length of stay
Health status (Quality of life)
The Short Form (36) Health Survey
Quality of life (QOL) in patients with pancreatic cancer
PAN-26 questionnaire
Quality of life (QOL) of cancer patients
QLQ-C30 questionnaire
Cost-effectiveness
Total cost ($) of the treatment
Full Information
NCT ID
NCT04801082
First Posted
March 8, 2021
Last Updated
March 17, 2021
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04801082
Brief Title
Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain
Official Title
Endoscopic Ultrasound-Guided Coeliac Plexus Neurolysis for Cancer Pain: Chemical Versus Radiofrequency Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EUS-CPB
Arm Type
Active Comparator
Arm Description
Endoscopic Ultrasound Guided Coeliac Plexus Block
Arm Title
EUS-CPA
Arm Type
Active Comparator
Arm Description
Endoscopic Ultrasound Guided Coeliac Plexus Radiofrequency Ablation
Intervention Type
Drug
Intervention Name(s)
Alcohol injection
Other Intervention Name(s)
Chemical Ablation
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Radiofrequency Ablation
Other Intervention Name(s)
RFA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of pain score
Description
change of pain score at 4th week after the procedure (by VAS score)
Time Frame
4 weeks after the procedure
Secondary Outcome Measure Information:
Title
Change of pain score
Description
change of pain score (Visual Analog Score) after the procedure
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Analgesic requirement
Description
decrease in analgesic requirement
Time Frame
Up to 100 months (From the date of procedure until the date of death from any cause)
Title
Technical success rate
Description
technical success rate
Time Frame
1 day
Title
Clinical success rate
Description
decrease in pain level by 30% from the pre-procedural baseline
Time Frame
Through study completion, an average of 2 year
Title
Duration of procedure
Description
time from injection of pre-medication to procedure last observation recording at the procedure suite
Time Frame
Up to 1 hour
Title
Time to pain score drop by 50%
Description
Time to Visual Analog Score drop by 50%
Time Frame
Through study completion, an average of 2 year
Title
Short term complication rate
Description
complication rate
Time Frame
Up to 1 week
Title
Long term complication rate
Description
complication rate
Time Frame
Through study completion, an average of 2 year
Title
Hospital length of stay
Description
Hospital length of stay
Time Frame
Up to 100 months
Title
Health status (Quality of life)
Description
The Short Form (36) Health Survey
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Quality of life (QOL) in patients with pancreatic cancer
Description
PAN-26 questionnaire
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Quality of life (QOL) of cancer patients
Description
QLQ-C30 questionnaire
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Cost-effectiveness
Description
Total cost ($) of the treatment
Time Frame
Through study completion, an average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wan Yee Chiu, BISC
Phone
+852 2255 4848
Email
krissy23@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Wing Ma, MBBS, MS
Phone
+852 2255 3025
Email
kawingma@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ka Wing Ma, MBBS, MS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
ZIP/Postal Code
000000
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ka Wing Ma, MBBS, MS
Phone
+852 2255 3025
Email
kawingma@hku.hk
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain
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