Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis

Study Overview
=================
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.

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

Conditions
-----------------
Cancer Pain

Intervention / Treatment
-----------------
* Other: Coeliac plexus neurolysis
* Other: Splanchnic nerve neurolysis


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coeliac plexus neurolysis (CPN)<br>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). | Other: Coeliac plexus neurolysis<br>* 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).<br>|
| Experimental: Splanchnic nerve neurolysis (SNN)<br>Splanchnic nerve neurolysis (SNN) will be performed bilaterally. Neurolytic solution will be injected around the splanchnic nerves (a nerve located at thoracic trunk). | Other: Splanchnic nerve neurolysis<br>* Splanchnic nerve neurolysis (SNN) will be performed bilaterally. Neurolytic solution will be injected around the splanchnic nerves (a nerve located at thoracic trunk).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | Pain intensity using numerical rating scale from 0 to 10 where 0 is no pain and 10 is the worst pain. | at one week after procedure |