NCT04475705 Propofol vs Sevo for Paediatric Tumor Surgery
| NCT ID | NCT04475705 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hong Kong Children's Hospital |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-01-11 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2021-01-11 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Retrospective studies and meta-analyses have shown a reduction in 5-year survival following inhalational based compared to propofol based total intravenous (TIVA) anaesthesia for cancer surgery. To date there have been no prospective trials published which evaluate the effect of anaesthetic technique on circulating tumour cells (CTC), oxidative stress, and recurrence rate following cancer surgery. Children with cancer often require surgery for tumour excision as well as for other diagnostic and therapeutic procedures. To date there has been no prospective randomized controlled trial evaluating the optimal anaesthetic technique for surgery on children with cancer. Aim: This is a pilot study in paediatric patients who require surgery for tumour excision. The aim is to investigate the effect of sevoflurane inhalational versus propofol intravenous anaesthesia on expression of hypoxia-inducible factor 1 (HIF-1), circulating tumour cells, DNA damage and biomarkers of immunity and inflammation in patients before and after tumour surgery. The patients will be followed up for up to 5 years for tumour recurrence after surgery. Method: This will be a single-blinded randomized controlled trial. One hundred children undergoing tumour excision surgery at the Hong Kong Children's Hospital will be recruited and randomized to receive TIVA or inhalational anaesthesia. Baseline, intraoperative and postoperative blood will be taken for tests of immunity and inflammatory markers, DNA damage and circulating tumour cells. Patients would be followed up to 3 years for tumour recurrence and survival.
Eligibility Criteria
Inclusion Criteria: * patients coming for elective primary solid tumor resection for curative intent in Hong Kong Children's Hospital * AND patients \> 5kg * AND patients within age limit Exclusion Criteria: * Autoimmune / Chronic inflammatory diseases e.g. Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) etc. * Current Steroid therapy * Surgery for tumour removal in the past year * Allergy to Propofol * intraoperative use of nitrous oxide * Patient susceptible to Malignant Hyperthermia * Patients / parents / legal guardians showing preference in anaesthetic techniques during recruitment process
Contact & Investigator
Sau Man Lee, MBBS
PRINCIPAL INVESTIGATOR
Hong Kong Children's Hospital
Frequently Asked Questions
Who can join the NCT04475705 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 18 Years, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04475705 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04475705 currently recruiting?
Yes, NCT04475705 is actively recruiting participants. Contact the research team at lsm335@gmail.com for enrollment information.
Where is the NCT04475705 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT04475705 clinical trial?
NCT04475705 is sponsored by Hong Kong Children's Hospital. The principal investigator is Sau Man Lee, MBBS at Hong Kong Children's Hospital. The trial plans to enroll 100 participants.