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EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy

Primary Purpose

Cancer of Pancreas, Pancreatic Neoplasms, Pain

Status
Recruiting
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
98% dehydrated alcohol
19G EUSRA needle, Taewoong Medical, Korea
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Pancreas focused on measuring Endoscopic Ultrasound Guided, Radiofrequency Ablation, Coeliac plexus neurolysis, Pancreatic cancer, Pain Relief, Chemical coeliac plexus neurolysis, Coeliac plexus ablation, Cancer pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18 year-old
  • Patients who give informed consent to the study
  • Suboptimal pain control with regular analgesics
  • Inoperable cancer of pancreas

Exclusion Criteria:

  • Patients who refuse to give consent
  • Patients aged <18 years
  • EUS not possible due to:

Problem related to scope insertion such as trismus, stenosis of the upper GI tract Coagulopathy with INR >1.5 or platelet count < 70

  • Low oxygen saturation or extreme blood pressure render endoscopic procedure unsafe

Sites / Locations

  • Queen Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EUS-CPB

EUS-CPA

Arm Description

Chemical ablation of the coeliac plexus

Radiofrequency ablation of the coeliac plexus

Outcomes

Primary Outcome Measures

Pain score
Pain score at 4 weeks after procedure (by VAS score)

Secondary Outcome Measures

Technical success rate
Technical success rate
Clinical success rate
Decrease of pain level by 30% from pre-procedural baseline
Duration of procedure
Time from injection of pre-medication to procedure last observation recording at the procedure suite
Time to pain score drop by 50%
Time to Visual Analog Score drop by 50%
Short term complication rate
Complication rate
Long term complication rate
Complication rate
Hospital length of stay
Hospital length of stay
Health status (Quality of life)
The Short Form (36) Health Survey
Quality of life (QOL) in patients with pancreatic cancer
PAN-26 questionnaire
Quality of life (QOL) of cancer patients
QLQ-C30 questionnaire
Cost-effectiveness of two types approach
Total cost ($) of treatment

Full Information

First Posted
March 10, 2021
Last Updated
March 17, 2021
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04809935
Brief Title
EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy
Official Title
Endoscopic Ultrasound Guided Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Intractable Pain Due to Malignancy A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
Many cancer patients suffer from intractable pain and which is often suboptimally controlled by even strong opioid analgesics. Coeliac plexus neurolysis (CPN) is procedure which intended to permanently destroy the nociceptive pathway that transmits the pain caused by the tumour. It can be with different approaches, such as percutaneously guided by fluoroscopy, echo-endoscopically or surgically with endoscopic approach being the more popular one in many centers equipped with echo-endoscopic services. The effect of CPN has been well established by some retrospective series. The overall response rate to CPN ranges from 70-90%, however, the analgesic effect is limited and up to roughly around 3 months. It is believed that the short-lasting analgesic effect is related to incomplete neurolysis by absolute alcohol injection. Recently, radiofrequency ablation (RFA) of coeliac plexus has been introduced as another mode of CPN. So far, only one small single center randomized controlled trial (RCT) suggesting superior performance in favour to CPN using RFA. This result has to be validated and by a RCT with larger sample size. In addition, data concerning the quality of life (QOL) improvement and cost-effectiveness need to be further elucidated. Therefore, the aim of this study is to perform a RCT to look into these issues.
Detailed Description
The aim of this study is to compare the efficacy of EUS-guided CPN versus radiofrequency ablation in patients with pain related to pancreatic cancer. By performing a randomized controlled trial, the clinical outcomes and cost-effectiveness of this new RFA treatment approach can be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Pancreas, Pancreatic Neoplasms, Pain, Cancer-Associated Pain, Pain Management
Keywords
Endoscopic Ultrasound Guided, Radiofrequency Ablation, Coeliac plexus neurolysis, Pancreatic cancer, Pain Relief, Chemical coeliac plexus neurolysis, Coeliac plexus ablation, Cancer pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EUS-CPB
Arm Type
Active Comparator
Arm Description
Chemical ablation of the coeliac plexus
Arm Title
EUS-CPA
Arm Type
Active Comparator
Arm Description
Radiofrequency ablation of the coeliac plexus
Intervention Type
Drug
Intervention Name(s)
98% dehydrated alcohol
Other Intervention Name(s)
Chemical Ablation
Intervention Description
coeliac plexus is identified and punctured Injection of 10 mL of .25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol.
Intervention Type
Device
Intervention Name(s)
19G EUSRA needle, Taewoong Medical, Korea
Intervention Description
10W-30W RFA will be applied unilaterally or bilaterally depends on individual anatomical characteristics for 10-50s Complete ablation of coeliac plexus nervous tissue is confirmed by appearance of air-bubble ultrasound scan
Primary Outcome Measure Information:
Title
Pain score
Description
Pain score at 4 weeks after procedure (by VAS score)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Technical success rate
Description
Technical success rate
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Clinical success rate
Description
Decrease of pain level by 30% from pre-procedural baseline
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Duration of procedure
Description
Time from injection of pre-medication to procedure last observation recording at the procedure suite
Time Frame
Up to 1 hour
Title
Time to pain score drop by 50%
Description
Time to Visual Analog Score drop by 50%
Time Frame
Through study completion, an average of 2 year
Title
Short term complication rate
Description
Complication rate
Time Frame
Up to 1 week
Title
Long term complication rate
Description
Complication rate
Time Frame
Through study completion, an average of 2 year
Title
Hospital length of stay
Description
Hospital length of stay
Time Frame
Up to 100 months
Title
Health status (Quality of life)
Description
The Short Form (36) Health Survey
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Quality of life (QOL) in patients with pancreatic cancer
Description
PAN-26 questionnaire
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Quality of life (QOL) of cancer patients
Description
QLQ-C30 questionnaire
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Cost-effectiveness of two types approach
Description
Total cost ($) of treatment
Time Frame
Through study completion, an average of 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 year-old Patients who give informed consent to the study Suboptimal pain control with regular analgesics Inoperable cancer of pancreas Exclusion Criteria: Patients who refuse to give consent Patients aged <18 years EUS not possible due to: Problem related to scope insertion such as trismus, stenosis of the upper GI tract Coagulopathy with INR >1.5 or platelet count < 70 Low oxygen saturation or extreme blood pressure render endoscopic procedure unsafe
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wan Yee Chiu, BISC
Phone
+852 2255 4848
Email
krissy23@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ka Wing Ma, MBBS, MS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
000000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan Yee Chiu, BISC
Phone
+852 2255 4848
Email
krissy23@hku.hk
First Name & Middle Initial & Last Name & Degree
Ka Wing Ma, MBBS, MS

12. IPD Sharing Statement

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EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy

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