Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis | NCT05541211

Studies
Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis

NCT05541211

Sponsor

The University of Hong Kong

Status

Unknown status

Last Update Posted

Dec 6, 2023Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Cancer Pain

Interventions

Coeliac plexus neurolysis
Splanchnic nerve neurolysis

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Sep 30, 2024Estimated

Completion Date

Mar 31, 2025Estimated

First Submitted Date

Sep 7, 2022

First Submission Date that Met QC Criteria

Sep 12, 2022

First Posted Date

Sep 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2023

Last Update Posted Date

Dec 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Chan Chi-Wing, Honorary Clinical Associate Professor, The University of Hong KongPrincipal Investigator

Lead Sponsor

The University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

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 Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Timmy CW Chan, MBBS	Contact	22555791		timmychancw@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Mary Hospital	Recruiting	Hong Kong			Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000072716	Cancer Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

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