Clinical trial NCT05541211: 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
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Pain
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Primary outcomes:
measure: pain score
timeFrame: at one week after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References: