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The purpose of this study is to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE) + microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) >3-<5 cm.
This study aims to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE)+microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) >3-<5 cm.
This randomized controlled trial screened 278 patients with HCC >3-<5 cm. Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3). Patients were followed-up with contrast-enhanced CT or MRI. Images were evaluated and compared for treatment response and adverse events based on modified response evaluation criteria in solid tumor. Serum alpha-fetoprotein (AFP) concentration was measured at baseline and during every follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined therapy | Experimental | Patients undergoing combined therapy |
|
| Transarterial chemoembolization | Active Comparator | Patients undergoing Transarterial chemoembolization |
|
| Microwave ablation | Active Comparator | Patients undergoing Microwave ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined therapy | Procedure | Patients undergoing combined therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Images were evaluated and compared for adverse events. The adverse events were recorded and classified following the guidelines of the Society of Interventional Radiology | Up to three years after procedure |
| Treatment Response | Tumor response was evaluated by CECT or dynamic MRI based on the modified response evaluation criteria in solid tumor (m-RECIST) established by the American Association for the Study of Liver Diseases. | One month |
| Recurrence rate | The recurrence rate was measured in relation to management lines. | 12 months after procedure |
| Overall mortality rate | The mortality rate was measured in relation to management lines. | Three years after procedure |
| Progression-free survival | The progression-free survival was measured in relation to management lines. | Three years after procedure |
| AFP variation rate | The AFP variation rate (ΔAFP) was defined as the percentage of change between the AFP concentration at baseline and the postprocedure AFP concentration after 1-2 months as shown in the following equation: ΔAFP (%) = [(AFPbaseline-AFPpostprocedure) /AFPbaseline] ×100% | Baseline and 1-2 months after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad A Basha, Professor | Zagazig University, Egypt | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33615957 | Derived | Zaitoun MMA, Elsayed SB, Zaitoun NA, Soliman RK, Elmokadem AH, Farag AA, Amer M, Hendi AM, Mahmoud NEM, Salah El Deen D, Alsowey AM, Shahin S, Basha MAA. Combined therapy with conventional trans-arterial chemoembolization (cTACE) and microwave ablation (MWA) for hepatocellular carcinoma >3-<5 cm. Int J Hyperthermia. 2021;38(1):248-256. doi: 10.1080/02656736.2021.1887941. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011616 | Psychotherapy, Multiple |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3).
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| Microwave ablation | Procedure | Patients undergoing Microwave ablation |
|
| Transarterial chemoembolization | Procedure | Patients undergoing Transarterial chemoembolization |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |