- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03082378
Central Obesity and Hepatocellular Carcinoma
Central Obesity and the Prognosis of Hepatocellular Carcinoma After Microwave Ablation
Recurrence and metastases after microwave ablation(MWA) of hepatocellular carcinoma(HCC) are the major factors that influence the survival. Obesity has been reported was significantly correlated with increased risk of developing HCC.
In this study, we will analysis the association of multiple obesity index(waist circumference,waist-hip ratio and body mass index) with the prognosis of HCC treated by MWA.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100853
- Rekruttering
- Chinese PLA General Hospital
-
Kontakt:
- Mengjuan Mu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- absence of ascites or the depth of ascites on US detection less than 4 cm;
- a normal serum total bilirubin level or less than 60 µmol/L;
- a normal albumin level or not less than 30 g/L;
- for radical treatment, single lesion of 8 cm or smaller, three or fewer multiple lesions with a maximum diameter of 4 cm or less, absence of portal vein cancerous thrombus or extrahepatic metastases;
- for palliative treatment, those with large or multiple lesions, suffering multiple metastases and unsuitable for other modalities can be considered to undergo the MWA on the condition of good hepatic function and blood coagulation function to tolerate the procedure.
Exclusion Criteria:
- clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state
- severe blood coagulation dysfunction (prothrombin time of more than 30 seconds, prothrombin activity less than 40%, and platelet count less than 30 cells×109/L)
- high intrahepatic tumor burden (tumor volume >70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden
- acute or active inflammatory and infectious lesions at any organ
- acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction
- relative contraindication concerns medical risk for the tumor proximity to diaphragm, gastrointestinal tract, gallbladder, pancreas, hepatic hilum and major bile duct or vessels, which may require adjunctive techniques to prevent off-target heating of adjacent structures during the ablation procedure.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
survival
Tidsramme: 3 years
|
Percentage of participants who survived up to end time point as assessed by Kaplan-Meier
|
3 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
intra-hepatic metastasis
Tidsramme: 3 years
|
Percentage of participants who present metastasis in the liver up to end time point as assessed by Kaplan-Meier
|
3 years
|
extra-hepatic metastasis
Tidsramme: 3 years
|
Percentage of participants who present metastasis outside the liver up to end time point as assessed by Kaplan-Meier
|
3 years
|
local tumor progression
Tidsramme: 3 years
|
Percentage of participants who present tumor progression around the ablation zone up to end time point as assessed by Kaplan-Meier
|
3 years
|
complication
Tidsramme: 3 years
|
number of participants with side effect and major complication
|
3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jie Yu, Dr, Chinese PLA General Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Adenocarcinom
- Neoplasmer, kirtel og epitel
- Neoplasmer i fordøjelsessystemet
- Leversygdomme
- Overernæring
- Ernæringsforstyrrelser
- Overvægtig
- Kropsvægt
- Neoplasmer i leveren
- Fedme
- Karcinom
- Carcinom, hepatocellulært
- Fedme, Abdominal
Andre undersøgelses-id-numre
- 301jrcsk
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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