Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis

Study Overview

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.

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.

Cancer Pain

OTHER: Coeliac plexus neurolysis
OTHER: Splanchnic nerve neurolysis

UW22-536

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-09-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-11-29
First Submitted that Met QC Criteria 2022-09-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-12-06
First Posted (ACTUAL) 2022-09-15	Results First Posted N/A	Last Verified 2023-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Triple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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).	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).
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).	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).

Participant Group/Arm

Intervention/Treatment

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).

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).

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).

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).

Primary Outcome Measures	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Timmy CW Chan, MBBS

Phone Number: 22555791

Email: timmychancw@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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