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Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis

NCT ID: NCT05541211

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The patients and independent investigators collecting outcome data will be blinded.

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Coeliac plexus neurolysis

Intervention Type 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).

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).

Group Type EXPERIMENTAL

Splanchnic nerve neurolysis

Intervention Type OTHER

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

Interventions

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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).

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Chan Chi-Wing

Honorary Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Timmy CW Chan, MBBS

Role: CONTACT

Phone: 22555791

Email: [email protected]

Facility Contacts

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Chi Wing Chan, MBBS

Role: primary

Other Identifiers

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UW22-536

Identifier Type: -

Identifier Source: org_study_id