Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis

NCT05541211 | Unknown

• 1 other identifier: UW22-536
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Coeliac plexus neurolysis (CPN)

ACTIVE COMPARATOR

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

Splanchnic nerve neurolysis (SNN)

EXPERIMENTAL

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

Interventions

Coeliac plexus neurolysis OTHER

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).

Coeliac plexus neurolysis (CPN)

Splanchnic nerve neurolysis OTHER

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

Splanchnic nerve neurolysis (SNN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Timmy CW Chan, MBBS

CONTACT

22555791; timmychancw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients and independent investigators collecting outcome data will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 15, 2022
• Study Start: December 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: March 31, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)