Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05541211
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The University of Hong Kong
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Hong Kong
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cancer Pain
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Coeliac plexus neurolysis (CPN)

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).

Experimental: Splanchnic nerve neurolysis (SNN)

Splanchnic nerve neurolysis (SNN) will be performed bilaterally. Neurolytic solution will be injected around the splanchnic nerves (a nerve located at thoracic trunk).

Interventions

Other: - Coeliac plexus neurolysis

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: - Splanchnic nerve neurolysis

Splanchnic nerve neurolysis (SNN) will be performed bilaterally. Neurolytic solution will be injected around the splanchnic nerves (a nerve located at thoracic trunk).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Queen Mary Hospital, Hong Kong, Hong Kong

Status

Recruiting

Address

Queen Mary Hospital

Hong Kong, ,

Site Contact

Chi Wing Chan, MBBS

timmychancw@gmail.com

2255 5791

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