Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001005640
Ethics application status
Approved
Date submitted
29/08/2023
Date registered
15/09/2023
Date last updated
15/09/2023
Date data sharing statement initially provided
15/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of coeliac plexus neurolysis on pain and quality of life in patients with pancreatic cancer
Scientific title
Impact of coeliac plexus neurolysis on pain and quality of life in patients with pancreatic cancer
Secondary ID [1] 310491 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic cancer 331281 0
Condition category
Condition code
Cancer 328039 328039 0 0
Pancreatic
Anaesthesiology 328122 328122 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Endoscopic ultrasound (EUS) - coeliac plexus neurolysis (CPN) is an endoscopic procedure performed by interventional gastroenterologists. CPN is achieved by the injection of a neurolytic agent into the CP or specific coeliac ganglia causing neurolysis or destruction of the CP or ganglia. The neurolytic agent is either pure alcohol or 10% phenol. The procedure takes 20-30minutes. It is a single procedure. Either induces a local inflammatory reaction followed by fibrosis during the healing process. EUS-CPN is conducted as a day-only procedure under deep intravenous sedation. Recovery is swift and patients are discharged home the same day. This is not a new or complex procedure. Patients may have access to the procedure routinely if their treating clinician refers them to have this procedure. Historically, clinicians have not referred patients for the procedure due to a lengthy time to access the procedure logistically. This study seeks to validate utility of the procedure to be able to set up proper processes so patients may access it faster and the hospital provide a more efficient service. Research findings will assist uptake of evidence into this process.
Intervention code [1] 327007 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335911 0
Change in Pain scores from T1 (Day of procedure, EUS-CPN) to T3 (1 month post EUS-CPN procedure).
* Likert pain score out of 10, This is recorded in a pain diary, morning and night for 3 months.

Timepoint [1] 335911 0
T1 (Day of EUS-CPN procedure, before procedure) - T3 (1-month post EUS-CPN procedure, anytime of the day as this is a clinic appointment at any time of the day)
Primary outcome [2] 335912 0
Change in Quality-of-life (QOL) survey data from T1 (Day of procedure, EUS-CPN) to T1 -T3 (1 month post EUS-CPN procedure).
* PAN-26
Timepoint [2] 335912 0
Change in QOL domain scores from T1 (Day of procedure, EUS-CPN) to T3 (1 month post EUS-CPN procedure).
Primary outcome [3] 335994 0
Change in Quality-of-life (QOL) survey data from T1 (Day of procedure, EUS-CPN) to T1 -T3 (1 month post EUS-CPN procedure).
*EORTC-QLQ C30.
Timepoint [3] 335994 0
Change in QOL domain scores from T1 (Day of procedure, EUS-CPN) to T3 (1 month post EUS-CPN procedure). This is a composite outcome.
Secondary outcome [1] 426108 0
*Quality of life assessment using PAN-26
Timepoint [1] 426108 0
*t0 (pre-procedure)
*t2 (2 weeks post EUS-CPN)
*t4 (2 months post EUS-CPN)
*t5 (3 months post EUS-CPN
*t6 (6 months post EUS-CPN)
Secondary outcome [2] 426110 0
Pain scores
* Likert pain score out of 10. This is recorded in a pain diary, morning and night for 3 months.
Timepoint [2] 426110 0
*t0 (pre-procedure)
*t2 (2 weeks post EUS-CPN)
*t4 (2 months post EUS-CPN)
*t5 (3 months post EUS-CPN)
Secondary outcome [3] 426111 0
Re-intervention rate. This will be assessed at the 3-month clinic appointment with the research doctor and entered on the case report form.
Timepoint [3] 426111 0
t5 (3 months post EUS-CPN procedure)
Secondary outcome [4] 426112 0
Adverse Events.
Participants will be asked at these timepoints. Unexpected presentation to the emergency department or admission to hospital and the nature of the event and treatment will be recorded. This study is not pre-emptively categorising adverse events, and it is unknown what they may be. To stay broad with data collection for safest practice is to not limit adverse events to single signs and symptoms and how they are measured. Rather each AE will be assessed by the medical team and categorised in summary after the study has been completed.
Timepoint [4] 426112 0
* Day 2-3 (post EUS-CPN procedure)
*2 weeks (post EUS-CPN procedure) -t2
*1-months (post EUS-CPN procedure) - t3
*2-months (post EUS-CPN procedure) -t4
*3-months (post EUS-CPN procedure)-t5
*6-months (post EUS-CPN procedure)-t6
Secondary outcome [5] 426115 0
Change in weight and Body Mass Index (BMI). Height is measured by a stadiometer and weight by a digital weight scale at t1 and t3 n the day of the EUS-CPN procedure. Both of these values will be used to calculate the BMI.
Timepoint [5] 426115 0
(t1) at time of EUS-CPN procedure)
*(t3) 1 month (post EUS-CPN procedure)
Secondary outcome [6] 426116 0
Survival rate
Timepoint [6] 426116 0
6 months post EUS-CPN procedure
12 months post EUS-CPN procedure
Secondary outcome [7] 426117 0
EUS technical approach will be collected on the case report form for the study.
Timepoint [7] 426117 0
During EUS-CPN procedure
Secondary outcome [8] 426118 0
C-Reactive Protein (CRP) - blood sample
Timepoint [8] 426118 0
t1 - At time of EUS-CPN procedure
t3 - 1 month post EUS procedure
Secondary outcome [9] 426119 0
Re-admission rate to hospital This will be collected by the research staff member at the time points below and verified by the patient medical records.
Timepoint [9] 426119 0
*2 weeks (post EUS-CPN procedure) -t2
*1-months (post EUS-CPN procedure) - t3
*2-months (post EUS-CPN procedure) -t4
*3-months (post EUS-CPN procedure)-t5
*6-months (post EUS-CPN procedure)-t6
Secondary outcome [10] 426123 0
Mortality rate
Timepoint [10] 426123 0
12 months post EUS-CPN procedure
Secondary outcome [11] 426392 0
*Change in analgesic requirements
Timepoint [11] 426392 0
Change in opiate requirements from T1 (Day of procedure, EUS-CPN) to T3 (1 month post EUS-CPN procedure). This is recorded in a pain diary, morning and night for 3 months. This will measure change in mg of drug required for pain relief.
Secondary outcome [12] 426395 0
*Quality of life assessed using EORTC-QLQ C30.
Timepoint [12] 426395 0
*t0 (pre-procedure)
*t2 (2 weeks post EUS-CPN)
*t4 (2 months post EUS-CPN)
*t5 (3 months post EUS-CPN
*t6 (6 months post EUS-CPN)
Secondary outcome [13] 426396 0
*Change in analgesic requirements. This data is collected at each patient encounter clinic time point and also patient pain diary.
Timepoint [13] 426396 0
*t0 (pre-procedure)
*t2 (2 weeks post EUS-CPN)
*t4 (2 months post EUS-CPN)
*t5 (3 months post EUS-CPN)
Secondary outcome [14] 426426 0
Erythrosedimentation rate (ESR)- blood sample
Timepoint [14] 426426 0
t1 - At time of EUS-CPN procedure
t3 - 1 month post EUS procedure
Secondary outcome [15] 426427 0
International normalised ratio (INR) - blood sample
Timepoint [15] 426427 0
t1 - At time of EUS-CPN procedure
t3 - 1 month post EUS procedure
Secondary outcome [16] 426431 0
CA19-9 (blood sample)
Timepoint [16] 426431 0
t1 - At time of EUS-CPN procedure
t3 - 1 month post EUS procedure
Secondary outcome [17] 426432 0
Albumin (blood sample)
Timepoint [17] 426432 0
t1 - At time of EUS-CPN procedure
t3 - 1 month post EUS procedure
Secondary outcome [18] 426434 0
Bilirubin (blood sample)
Timepoint [18] 426434 0
t1 - At time of EUS-CPN procedure
t3 - 1 month post EUS procedure

Eligibility
Key inclusion criteria
• All patients with a confirmed clinical diagnosis of pancreatic cancer
• Medical documentation and treatment of abdominal pain as established by need for regular opiate use
• 18 years and over
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Advanced disease state that is impacting on capacity to consent
• Patients who have painless PC not requiring regular opiate medication to treat pain,
• Elevated INR > 1.5
• Decompensated cardiac failure (NYHA class IV)
• Decompensated liver failure (Child-Pugh score B/C)
• Severe hypotension (sBP<85mmHg)
• Currently pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/10/2023
Actual
Date of last participant enrolment
Anticipated
16/10/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25470 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 41278 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 314692 0
Hospital
Name [1] 314692 0
Royal Brisbane & Women's Hospital
Country [1] 314692 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane & Women's Hospital
Address
Department of Gastroenterology & Hepatology,
Butterfield Street, Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 316666 0
None
Name [1] 316666 0
Address [1] 316666 0
Country [1] 316666 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313709 0
Metro North Health Human Research Committee A (EC 00172)
Ethics committee address [1] 313709 0
Ethics committee country [1] 313709 0
Australia
Date submitted for ethics approval [1] 313709 0
17/04/2023
Approval date [1] 313709 0
09/06/2023
Ethics approval number [1] 313709 0
HREC/2023/MNHA/94893

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129090 0
Dr Jason Huang
Address 129090 0
Royal Brisbane & Women's HospitalLevel 9 Ned Hanlon BuildingDepartment of GastroenterologyButterfield Street, Herston, 4029, Queensland
Country 129090 0
Australia
Phone 129090 0
+61 7 36470335
Fax 129090 0
Email 129090 0
[email protected]
Contact person for public queries
Name 129091 0
Kimberley Ryan
Address 129091 0
Royal Brisbane & Women's HospitalLevel 9 Ned Hanlon BuildingDepartment of GastroenterologyButterfield Street, Herston, 4029, Queensland
Country 129091 0
Australia
Phone 129091 0
+61 7 36462673
Fax 129091 0
Email 129091 0
[email protected]
Contact person for scientific queries
Name 129092 0
Kimberley Ryan
Address 129092 0
Royal Brisbane & Women's HospitalLevel 9 Ned Hanlon BuildingDepartment of GastroenterologyButterfield Street, Herston, 4029, Queensland
Country 129092 0
Australia
Phone 129092 0
+61 7 36462673
Fax 129092 0
Email 129092 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data is not approved to be shared. It is not approved in the participant consent form and has not been approved by the HREC.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.