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Hepatocellular CarcinomaPhase 2NCT05502458

Effect of Propofol and Desflurane on Nucleic Acid of Liver Circulating Tumor

A Phase 2 study testing Desflurane and Propofol in people with Hepatocellular Carcinoma and Desflurane Adverse Reaction, run by Zhejiang Cancer Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the effects of perioperative anesthetic drugs propofol and desflurane on circulating tumor nucleic acids (CK7, ELF3, EGFR and EphB4 mRNA) in the blood of patients with liver cancer, so as to provide scientific reference for clinical anesthesia in the perioperative treatment of tumor Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Desflurane and Propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Dec 2020to 8 Aug 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age range: 18 to 75
  • ASA: I-III
  • primary liver cancer (CNLC: Stage I-IIIA)
  • undergoing elective hepatectomy

Who cannot join

  • Patients with severe bradycardia (HR < 55bpm)
  • patients with severe arrhythmias or cardiac dysfunction (EF < 35%)
  • patients with severe respiratory lung disease
  • patients with severe liver and kidney insufficiency epilepsy
  • patients with severe hyperlipidemia
  • patients with a history of malignant hyperthermia
Show all 10Show fewer
  • patients with propofol or desflurane allergy
  • patients with history of preoperative chemoradiotherapy
  • patients who were on immunosuppressive treatment
  • patients with chronic opioid therapy declined to participate in the study

Trial locations and contacts

1 site in 1 country.

China1 site
  • Zhejiang Cancer hospital

    Hangzhou, Zhejiang, 310022

Other trials in China

About this study

To investigate the effects of perioperative anesthetic drugs propofol and desflurane on circulating tumor nucleic acids (CK7, ELF3, EGFR and EphB4 mRNA) in the blood of patients with liver cancer, so as to provide scientific reference for clinical anesthesia in the perioperative treatment of tumor

Read the detailed description

Hepatocellular carcinoma (HCC) is one of the most malignant tumors in oncology. Its incidence is increasing, and there is a lack of reliable biomarkers for early diagnosis, prognosis evaluation and efficacy evaluation. There is a pool of tumor molecules derived from primary tumors in the blood circulation, including Circulating tumor proteins, Circulating tumor cells (CTCs), Extracellular vesicles, Evs, Tumor "educated" platelets (TEPs), and Circulating Tumor nucleic acids, known as Circulating Tumor DNA, CtDNA is a Circulating cell-free DNA (ccfDNA). Liquid biopsy is performed to detect tumor molecules from blood circulation. Small RNA (miRNA) and long noncoding RNA (miRNA) in liquid biopsy are detected. Circulating tumor RNA (ctRNA), such as lncRNA, can be used as epigenetic biomarkers to improve the early diagnosis of HCC and to treat patients with early and advanced HCC. Propofol and desflurane, as important anesthesia drugs in perioperative period, have been shown to affect the concentration of circulating nucleic acid in patients. Furong Song found that propofol could inhibit the overexpression of HOXA11-AS, which reversed the inhibitory effect of propofol treatment on HCC cell progression, by promoting the expression of Mir-4458, and had an impact on HCC cell progression . However, Dongmei Wang and their colleagues found that circulating H19 inhibited the effect of propofol in promoting HCC cell apoptosis by upregulating LIMK1 (LIM domain kinase 1) through spongy Mir-520a-3p . Meanwhile, Buschmann and his team found that propofol and desflurane inhibited key cancer-related pathways such as proliferation and migration in colorectal cancer, and found that propofol did not affect the size distribution and protein labeling of circulating vesicles, but could reduce their concentration . Compared with inhaled anesthetics, Bon-Wook Koo found that HCC patients treated with propofol had a lower recurrence rate and a longer average recurrence time than those treated with inhaled anesthetics . Hou-chuan Lai found that compared with desflurane anesthesia regimen, propofol anesthesia regimen significantly improved the survival rate of patients with liver cancer without distant metastasis or local recurrence . Meanwhile, Frederique Hovaguimian found that in nonmetastatic and metastatic breast cancer, the maximum number of circulating tumor cells increased by 36% after sevoflurane inhalation anesthesia and was independently associated with a higher risk of disease recurrence and reduced survival . At this time, the monitoring of circulating tumor cells can represent promising methods, such as the detection of suitable markers of circulating tumor cells, such as Cytokeratin 7 (CK7), E74-like factor 3 (ELF3), Epidermal growth factor receptor (EGFR) and Peripheral blood mononuclear cells, The expression of erythropoietin-producing hepatocellular carcinoma receptor B4 (EphB4) mRNA in PMBCs, In order to better understand the effect of anesthesia on perioperative tumor treatment, this evidence has been supported by domestic and foreign studies . Soo-ho Lee and his colleagues found that CK7-negative liver cancer patients had a higher survival rate than all positive patients [9], which was supported by Xialing Huang and his team . Longbo Zheng found that ELF3 inhibits ZE1 by inhibiting Mir-141-3p, thereby inhibiting E-cadherin in HCC cells and promoting EMT, which is a potential prognostic biomarker and/or therapeutic target for HCC . Zhe Wu found that lncrNA-UBE2R2-AS1 in HCC shows carcinogenic effect through the up-regulation of EGFR by Mir-302b, and can be used as a potential therapeutic target and prognostic biomarker for HCC patients , and this mechanism of action was confirmed by Zhen-Jiang Ma and his research . At the same time, it was found that the expression level of EphB4 was increased in HCC tumor tissues, and the levels of EphB4 and P-JAK2 were positively correlated in samples of HCC patients , while the expression of CIRC-EPHB4 was down-regulated. Circ-ephb4 overexpression inhibited the viability of HCC cells, induced apoptosis, and inhibited cell migration and invasion by inhibiting the expression of hypoxia-inducible factor-1α (HIF-1α) . However, the perioperative effects and molecular mechanisms of propofol and desflurane on circulating tumor nucleic acids in liver cancer are not very clear at present, and further relevant studies are needed to clarify, so as to provide support and guidance for the development of perioperative anesthesia plan and clinical diagnosis of liver cancer.

Being tested
Desflurane, Propofol
Keywords
Desflurane, HCC, propofol, CTC
Medical subject headings
Carcinoma, Hepatocellular, Neoplastic Cells, Circulating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DesfluraneDrug

    Also called group D

    Propofol general anesthesia group (P group) : intravenous propofol infusion was slowly pushed until consciousness disappeared, and then anesthesia was maintained at 4-8 mg/kg/h. In the general anesthesia group with desflurane (group D), intravenous propofol infusion was slowly pushed until consciousness disappeared, and then anesthesia was maintained with 4-6% desflurane. The analgesic and muscle relaxant regimens were the same in both groups except for sedative drugs. All patients were treated with no medication before operation, and the operation was completed under endotracheal intubation and general anesthesia. The amount of propofol or desflurane was adjusted according to BIS or MAC values and hemodynamic changes during operation. Add 10mg of rocuronium every half hour. Vasoactive drugs can be used to maintain hemodynamic stability during the operation, and corresponding records should be made

  • PropofolDrug

    Also called group P

    Propofol general anesthesia group (P group) : intravenous propofol infusion was slowly pushed until consciousness disappeared, and then anesthesia was maintained at 4-8 mg/kg/h.

Study groups in NCT05502458
Study groupRoleWhat they receive
propofolActive comparatorpropofol(50ml,1g),Intravenous propofol infusion was slowly pushed until loss of consciousness, and anesthesia was maintained at 4-8 mg/kg/h
Receives: Drug: Propofol
desfluraneActive comparatorIn the general anesthesia group with desflurane( 240ml), intravenous propofol infusion was slowly pushed until consciousness disappeared, and then anesthesia was maintained with 4-6% desflurane
Receives: Drug: Desflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The changes of circulating tumor nucleic acids (CK7, ELF3, EGFR and EphB4 mRNA) in peripheral blood of patients with hepatocellular carcinoma after perioperative treatment with propofol and desflurane

    Circulating tumor nucleic acid (CK7, ELF3, EGFR, and EphB4 mRNA) concentrations were determined by real-time RT-PCR in Applied Biosystems 7500 (Foster City, CA, USA) using SYBR® Premix Ex TaqTM II (Po, Otsu, Japan). Sequence of primers designed as previously described. Total mRNA was normalized to GAPDH and relative mRNA expression of the sample by calculating 2- δδCT, and differential expression of the sample was defined as upregulation when the cutoff value was set to 2x

    Measured: Immediately Before induction of anesthesia, Immediately before skinning after induction of anesthesia, during operation, PACU at the end of operation, and on the 7th day after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2022
  2. Study start1 Dec 2020
  3. Primary completion8 Aug 2022
  4. Study completion8 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Propofol general anesthesia group (P group) : intravenous propofol infusion was slowly pushed until consciousness disappeared, and then anesthesia was maintained at 4-8 mg/kg/h. In the general anesthesia group with desflurane (group D), intravenous propofol infusion was slowly pushed until consciousness disappeared, and then anesthesia was maintained with 4-6% desflurane
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05502458
Sponsor's protocol ID
2020-09-01
Status last verified
Aug 2022
First submitted
9 Aug 2022
Last updated
16 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Desflurane and Propofol in people with Hepatocellular Carcinoma and Desflurane Adverse Reaction, run by Zhejiang Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The changes of circulating tumor nucleic acids (CK7, ELF3, EGFR and EphB4 mRNA) in peripheral blood of patients with hepatocellular carcinoma after perioperative treatment with propofol and desflurane (time frame: Immediately Before induction of anesthesia, Immediately before skinning after induction of anesthesia, during operation, PACU at the end of operation, and on the 7th day after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.

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