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Trial Title:
Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis
NCT ID:
NCT05541211
Condition:
Cancer Pain
Conditions: Official terms:
Cancer Pain
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking description:
The patients and independent investigators collecting outcome data will be blinded.
Intervention:
Intervention type:
Other
Intervention name:
Coeliac plexus neurolysis
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 group label:
Coeliac plexus neurolysis (CPN)
Intervention type:
Other
Intervention name:
Splanchnic nerve neurolysis
Description:
Splanchnic nerve neurolysis (SNN) will be performed bilaterally. Neurolytic solution will
be injected around the splanchnic nerves (a nerve located at thoracic trunk).
Arm group label:
Splanchnic nerve neurolysis (SNN)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Queen Mary Hospital
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Chi Wing Chan, MBBS
Phone:
2255 5791
Email:
timmychancw@gmail.com
Start date:
December 1, 2022
Completion date:
March 31, 2025
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05541211
