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A randomized controlled study of the clinical efficacy of laparoscopic reoperative resection versus microwave ablation for recurrent small hepatocellular carcinoma

A randomized controlled study of the clinical efficacy of laparoscopic reoperative resection versus microwave ablation for recurrent small hepatocellular carcinoma

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076275
Enrollment
Unknown
Registered
2023-09-28
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver cancer

Interventions

test group:Undergoing laparoscopic re-surgical resection
Control group:No laparoscopic reoperative resection treatment, microwave ablation treatment received

Sponsors

Third Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Between the ages of 18 and 75 years and of either sex; 2) Recurrent small hepatocellular carcinoma based on a history of partial hepatectomy for primary hepatocellular carcinoma and the American Association for the Study of Liver Diseases diagnostic criteria for HCC; and 3) Physical status scores for tumor patients followed the Eastern Cooperative Oncology Group ECOGPS score of 0 to 1 (0 for normal activity; 1 for mild symptoms, comfortable with life, and able to perform light physical activity); 4) R0 resection of the primary tumor without visible vascular invasion and extrahepatic distant metastases; and 5) No residual disease detected within the first 2 months after initial hepatectomy; and 6) RHCC is solitary and = 3 cm in diameter; 7) RHCC located at least 1.0 cm or more from the adjacent gastrointestinal tract, hepatic hilar, vena cava or main hepatic vein, gallbladder, and bottom of the diaphragm, which can technically be treated radically by percutaneous ablation or LLR; 8) Good general condition as well as tolerance of anesthesia, pneumoperitoneum and laparoscopic hepatectomy; 9) Liver function classification Child-Pugh A or B, preoperative indocyanine green 15-minute retention (ICGR15) 40%; 10) Prothrombin time (PT) less than 4 seconds in normal controls; 11) absence of hepatic encephalopathy or/and more than moderate amount of ascites, 12) gastroscopic esophageal vein without severe varices and no active peptic ulcer. 13) hemoglobin = 90g / L, white blood cell count = 3.0 × 109 / L, neutrophil count = 1.5 × 109 / L, platelet count = 40 × 109 / L;. (14) Renal function and cardiopulmonary function are basically normal. (15) No clear manifestation of malignant disease; 16) Expected life expectancy greater than three months, no pregnancy, no HIV or syphilis infection; 17) Those who can understand the study and have signed the informed consent. Prothrombin time (PT) was less than 4 seconds for normal controls;

Exclusion criteria

Exclusion criteria: (1) History of other malignant tumors within 5 years prior to enrollment; (2) Portal hypertension diagnosed by preoperative enhanced abdominal CT and endoscopy, history of esophageal variceal bleeding, severe hypersplenism syndrome, or refractory ascites; (3) History of any anti-RHCC therapy prior to enrollment, including via TACE, RFA, radiotherapy and chemotherapy; (4) History of spontaneous tumor rupture; (5) Postoperative pathology suggestive of metastatic cancer or primary cancer in other tissue types; (6) History of cerebrovascular accident within 6 months prior to enrollment; (7) History of unstable angina, myocardial infarction, or heart failure within the past 6 years months prior to inclusion; (8) History of surgical treatment for other diseases within 4 weeks prior to enrollment; (9) Severe lung disease (e.g., pulmonary fibrosis, severe emphysema, and pulmonary heart disease); or a forceful expiratory volume in 1 second (FEV1) 50 mmHg; (10) Serum creatinine > 1.25 times the upper limit of normal; (11) Poorly controlled acute or active infection (infection-induced fever >38°C); (12) Poorly controlled hypertension or diabetes mellitus; (13) Severe mental illness or disorder; (14) Suspected systemic or localized lymphadenopathy on imaging studies; (15) Receiving systemic administration of corticosteroids; (16) Oral administration of anticoagulants such as warfarin within 2 weeks; (17) Requirements for concomitant surgical treatment of other diseases; (18) Pregnant or nursing women; (19) Other serious underlying medical conditions; (20) Inability or refusal to comply with the rules (21) Participation in other clinical trials; (22) Refusal to provide informed consent; (23) Other reasons, in the opinion of the investigator, why participation in this trial is inappropriate. Key exclusion criteria were a history of other malignancies within the past 5 years, a history of spontaneous tumor rupture, a history of prior anti-RHCC therapy, severe concomitant disease, acute or active infectious disease, pregnancy, or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Overall lifetime;

Secondary

MeasureTime frame
Tumor recurrence rate;tumor marker;Imaging (enhanced CT or enhanced MRI of the liver);

Countries

China

Contacts

Public ContactWeixing Guo

Third Affiliated Hospital of Naval Medical University

weixingg88@126.com+86 139 1858 9919

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026