- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07815054
Efficacy Evaluation of Microwave Ablation Assisted by Diaphragm Hydrodissection for Hepatocellular Carcinoma and Comparative Analysis With Surgical
The goal of this observational study is to evaluate the local efficacy and safety of hydrodissection-assisted microwave ablation for patients with hepatocellular carcinoma, and to compare its therapeutic outcomes with surgical resection for hepatocellular carcinoma. The main questions it aims to answer are:
Is hydrodissection-assisted microwave ablation safe and effective for treating hepatocellular carcinoma? How does the therapeutic effect of hydrodissection-assisted microwave ablation compare with surgical resection for hepatocellular carcinoma? Patients who receive either microwave ablation or surgical resection will Undergo a 2-year follow-up period.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: dezhi Zhang Associate Chief Physician, MD
- Telefonnummer: +8618186876068
- E-post: dezhi@jlu.edu.cn
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:Patients with Child-Pugh grade A or B liver function.Single hepatic lesion with a maximum diameter ≤ 5 cm.The lesion is located in the subphrenic region with a distance ≤ 10 mm from the right diaphragm.
Exclusion Criteria:Presence of extrahepatic metastasis or other concomitant malignant tumors.Presence of severe cardiac, pulmonary, or renal dysfunction.Platelet count < 50×10⁹/L with irreversible coagulation disorders. Patients with incomplete imaging or clinical medical data.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Hydrodissection-assisted microwave ablation cohort
Patients with hepatocellular carcinoma receiving hydrodissection-assisted microwave ablation under routine clinical care.
No study-specific intervention will be assigned by researchers.
|
For subphrenic hepatocellular carcinoma treated with microwave ablation, ultrasound-guided injection of normal saline into the diaphragm is performed during ablation to establish a hydrodissection barrier and optimise lesion visualisation.
|
|
Surgical resection cohort
Patients with hepatocellular carcinoma receiving surgical resection under routine clinical care.
No study-specific intervention will be assigned by researchers.
|
Patients with subphrenic hepatocellular carcinoma who undergo surgical resection are managed according to clinical diagnostic and therapeutic standards for hepatocellular carcinoma.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free survival (PFS)
Tidsramme: Up to 2 years after treatment
|
the time from initiation of treatment to disease progression or death.
|
Up to 2 years after treatment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival (OS)
Tidsramme: Up to 2 years after treatment
|
the time from initiation of treatment to death, loss to follow-up, or last follow-up.
|
Up to 2 years after treatment
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-362
Plan for individuelle deltakerdata (IPD)
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