Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis
Primary Purpose
Cancer Pain
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Coeliac plexus neurolysis
Splanchnic nerve neurolysis
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Pain
Eligibility Criteria
Inclusion Criteria:
- Age>=18
- Diagnosis of unresectable intra-abdominal cancer
- Visceral pain attributable to the cancer with NRS >= 4
- Able to understand instructions, give consent, complete questionnaires
Exclusion Criteria:
- Primary pancreatic cancer or metastatic disease involving pancreas
- Gross celiac axis distortion identified on imaging
- Acute abdomen condition eg. Intraabdominal sepsis, tumor rupture
- Other non-cancer causes attributable to the pain
- Gross ascites
- Previous coeliac plexus or splanchnic nerve neurolysis
- Contraindications to neurolytic procedures eg. Bleeding tendency; local or systemic infections; allergic to local anesthetics, contrast or alcohol; intestinal obstruction; anatomical distortion along needle trajectory
- Patients believed to be inappropriate for study by investigators
Sites / Locations
- Queen Mary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CPN
SNN
Arm Description
Coeliac plexus neurolysis (CPN) will be performed bilaterally. Neurolytic solution will be injected around the coeliac plexus (a network of nerves located in the abdomen).
Splanchnic nerve neurolysis (SNN) will be performed bilaterally. Neurolytic solution will be injected around the splanchnic nerves (a nerve located at thoracic trunk).
Outcomes
Primary Outcome Measures
pain score
Pain intensity using numerical rating scale from 0 to 10 where 0 is no pain and 10 is the worst pain.
Secondary Outcome Measures
Full Information
NCT ID
NCT05541211
First Posted
September 7, 2022
Last Updated
May 9, 2023
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05541211
Brief Title
Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis
Official Title
Comparing the Effects of Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis for Non-pancreatic Upper Intra-abdominal Cancer Pain: a Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
September 30, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pain is prevalent among patients with gastrointestinal cancers. Standard procedures such as coeliac plexus neurolysis (CPN) is effective in reducing pain, opioid requirement and related side effects for pancreatic cancer cases. Meanwhile, splanchnic nerve neurolysis (SNN) as an alternative to CPN is more effective for cancer pain relief.
Although previous studies investigating the role of CPN/SNN mainly focus on pancreatic cancer cases, their efficacy on non-pancreatic abdominal cancer pain may not be accurately determined.
Detailed Description
Pain is prevalent among patients with gastrointestinal cancers. There is abundant evidence that coeliac plexus neurolysis (CPN) is effective in reducing pain, opioid requirement and related side effects for pancreatic cancer cases while the evidence for other upper abdominal cancer pain is less robust but emerging. Meanwhile, there is an increasing interest in utilising splanchnic nerve neurolysis (SNN) as an alternative to CPN for cancer pain relief.
Although previous studies investigating the role of CPN/SNN involved heterogenous types of intra-abdominal malignancies, majority of cases were pancreatic cancer. Therefore, their efficacy on non-pancreatic abdominal cancer pain may not be accurately determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The randomization sequence will be generated by Microsoft Excel software. Blocked randomization will be done with an allocation ratio of 1:1. This will be prepared by a statistician unaware of the nature of the clinical study. The sequence will be concealed in opaque envelopes and opened by an investigator just before the procedure. The patients and independent investigators collecting outcome data will be blinded
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The patients and independent investigators collecting outcome data will be blinded.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPN
Arm Type
Active Comparator
Arm Description
Coeliac plexus neurolysis (CPN) will be performed bilaterally. Neurolytic solution will be injected around the coeliac plexus (a network of nerves located in the abdomen).
Arm Title
SNN
Arm Type
Experimental
Arm Description
Splanchnic nerve neurolysis (SNN) will be performed bilaterally. Neurolytic solution will be injected around the splanchnic nerves (a nerve located at thoracic trunk).
Intervention Type
Other
Intervention Name(s)
Coeliac plexus neurolysis
Intervention Description
Coeliac plexus neurolysis (CPN) will be performed bilaterally. Neurolytic solution will be injected around the coeliac plexus (a network of nerves located in the abdomen).
Intervention Type
Other
Intervention Name(s)
Splanchnic nerve neurolysis
Intervention Description
Splanchnic nerve neurolysis (SNN) will be performed bilaterally. Neurolytic solution will be injected around the splanchnic nerves (a nerve located at thoracic trunk).
Primary Outcome Measure Information:
Title
pain score
Description
Pain intensity using numerical rating scale from 0 to 10 where 0 is no pain and 10 is the worst pain.
Time Frame
at one week after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age>=18
Diagnosis of unresectable intra-abdominal cancer
Visceral pain attributable to the cancer with NRS >= 4
Able to understand instructions, give consent, complete questionnaires
Exclusion Criteria:
Primary pancreatic cancer or metastatic disease involving pancreas
Gross celiac axis distortion identified on imaging
Acute abdomen condition eg. Intraabdominal sepsis, tumor rupture
Other non-cancer causes attributable to the pain
Gross ascites
Previous coeliac plexus or splanchnic nerve neurolysis
Contraindications to neurolytic procedures eg. Bleeding tendency; local or systemic infections; allergic to local anesthetics, contrast or alcohol; intestinal obstruction; anatomical distortion along needle trajectory
Patients believed to be inappropriate for study by investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timmy CW Chan, MBBS
Phone
22555791
Email
timmychancw@gmail.com
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Wing Chan, MBBS
Phone
2255 5791
Email
timmychancw@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis
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