Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma
Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma ----A Prospective Randomized Controlled Clinical Trail
The preventive lymphadenectomy is not performed routinely for hepatocellular carcinoma (HCC) patients in clinical practice. While many patients suffered the recurrence without the evidence of portal or hepatic vascular invasion or multiple loci, it lead to reconsider the value of preventive resection of regional lymph node for those patients. Recently, more and more studies had found the incidence of lymph node metastasis was higher in autopsy specimen than those in operable patients.
This project is a prospective randomized controlled trial, planning to compare hepatectomy with hepatectomy combined lymphadenectomy regarding of the safety and efficacy in HCC patients, to reach a further understanding of the role of lymphadenectomy.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Guangdong
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GuangZhou, Guangdong, Kina, 510060
- Sun Yat-sen University Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- age 18 to 65 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status is grade 0 or 1;
- good liver function with Pugh-Child Class A or B;
- indocyanine green retention at 15 minutes (ICG-R15) <15%;
- without severe cirrhosis;
- the diameter of tumor is equal to or more than 3 cm;
- the liver resection could be assessed R0 (the define of R0 resection will be explained in the section of Surgical procedures);
- absence of extrahepatic metastasis.
Exclusion Criteria:
- the diameter of tumor is less than 3 cm;
- palliative resection of tumor;
- with the history of hepatic encephalopathy, ascites, and variceal bleeding;
- with severe hepatic cirrhosis;
- tumor rupture;
- with the history of upper abdominal surgery, it is tough to remove the regional lymph nodes; or it is unable to be resected when multiple lymph nodes mixed and fixed.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: hepatectomy combined lymphadenectomy
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|
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Aktiv komparator: hepatectomy
hepatectomy alone
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrence-free survival
Tidsramme: 5 year
|
The recurrence-free survival time was defined as the time from the date of resection or ablation to the time of recurrence, metastasis or last follow-up.
|
5 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Post-operation complication
Tidsramme: 90-d after surgery
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90-d after surgery
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Yunfei Yuan, MD, Sun Yat-sen University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Rvrl2005
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