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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04801082
Other study ID # 202009185043
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date March 2021
Est. completion date March 31, 2025

Study information

Verified date March 2021
Source The University of Hong Kong
Contact Wan Yee Chiu, BISC
Phone +852 2255 4848
Email krissy23@hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The aim of this study is to compare the efficacy of EUS-CPN by chemical ablation using alcohol injection versus by radiofrequency ablation in patients with cancer pain related to intra-abdominal malignancy. This is a randomised controlled trial to assess the clinical outcomes and cost-effectiveness of this new treatment approach.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 54
Est. completion date March 31, 2025
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =18 year-old - Patients who give informed consent to the study - Suboptimal pain control with regular analgesics - Inoperable cancer of pancreas, biliary system and liver (both primary or secondary) 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Alcohol injection
Chemical ablation is performed by injection of 10 mL of 0.25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol using a 22G FNA needle (Cook and Olympus)
Device:
Radiofrequency Ablation
coeliac plexus is identified and punctured with 19G EUSRA RFA needle with 10W-30W of energy for 10-50s bilaterally or unilaterally depends on individual anatomical characteristics.

Locations

Country Name City State
Hong Kong The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of pain score change of pain score at 4th week after the procedure (by VAS score) 4 weeks after the procedure
Secondary Change of pain score change of pain score (Visual Analog Score) after the procedure 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Secondary Analgesic requirement decrease in analgesic requirement Up to 100 months (From the date of procedure until the date of death from any cause)
Secondary Technical success rate technical success rate 1 day
Secondary Clinical success rate decrease in pain level by 30% from the pre-procedural baseline Through study completion, an average of 2 year
Secondary Duration of procedure time from injection of pre-medication to procedure last observation recording at the procedure suite Up to 1 hour
Secondary Time to pain score drop by 50% Time to Visual Analog Score drop by 50% Through study completion, an average of 2 year
Secondary Short term complication rate complication rate Up to 1 week
Secondary Long term complication rate complication rate Through study completion, an average of 2 year
Secondary Hospital length of stay Hospital length of stay Up to 100 months
Secondary Health status (Quality of life) The Short Form (36) Health Survey 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Secondary Quality of life (QOL) in patients with pancreatic cancer PAN-26 questionnaire 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Secondary Quality of life (QOL) of cancer patients QLQ-C30 questionnaire 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Secondary Cost-effectiveness Total cost ($) of the treatment Through study completion, an average of 2 year
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