Clinical trial NCT03026452: Effectivity and Safety of Ultrasound-guided Percutaneously Radiofrequency Ablation for Liver Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Cancer
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of ultrasonography (US) -guided radiofrequency ablation for liver tumors, the investigators used preoperative and postoperative US/CEUS(contrast-enhanced ultrasonography)/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.


Eligibility criteria: Inclusion Criteria:

* Patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter), Patients with Child-Pugh A/B, Patients with PLT(platelet count) ≥ 50\*10e9/L and PT(prothrombin time) ≤ 20s.

Exclusion Criteria:

* Patients with blood coagulation dysfunction, ChildPugh score≥3, severe cardiopulmonary disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.

Primary outcomes:
measure: Tumor size assessed by MRI
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Carcinoembryonic Antigen (CEA) level assessed by ELISA
timeFrame: through study completion, an average of 2 year
measure: Alpha Fetoprotein (AFP) level assessed by ELISA
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References:
citation: Sasaki K, Margonis GA, Andreatos N, Kim Y, Wilson A, Gani F, Amini N, Pawlik TM. Combined resection and RFA in colorectal liver metastases: stratification of long-term outcomes. J Surg Res. 2016 Nov;206(1):182-189. doi: 10.1016/j.jss.2016.06.098. Epub 2016 Jul 4.
citation: Giorgio A, Merola MG, Montesarchio L, Merola F, Santoro B, Coppola C, Gatti P, Amendola F, DI Sarno A, Calvanese A, Matteucci P, Giorgio V. Sorafenib Combined with Radio-frequency Ablation Compared with Sorafenib Alone in Treatment of Hepatocellular Carcinoma Invading Portal Vein: A Western Randomized Controlled Trial. Anticancer Res. 2016 Nov;36(11):6179-6183. doi: 10.21873/anticanres.11211.
citation: Makino Y, Imai Y, Igura T, Kogita S, Sawai Y, Fukuda K, Iwamoto T, Okabe J, Takamura M, Fujita N, Hori M, Takehara T, Kudo M, Murakami T. Feasibility of Extracted-Overlay Fusion Imaging for Intraoperative Treatment Evaluation of Radiofrequency Ablation for Hepatocellular Carcinoma. Liver Cancer. 2016 Oct;5(4):269-279. doi: 10.1159/000449338. Epub 2016 Sep 14.
citation: Aissou S, Cartier V, Hamy A, Plumereau F, Aube C, Lermite E. Radiofrequency in the Management of Colorectal Liver Metastases: A 10-Year Experience at a Single Center. Surg Technol Int. 2016 Oct 26;29:99-105.
citation: Barat M, Fohlen A, Cassinotto C, Jannot AS, Dautry R, Pelage JP, Boudiaf M, Pocard M, Eveno C, Taouli B, Soyer P, Dohan A. One-month apparent diffusion coefficient correlates with response to radiofrequency ablation of hepatocellular carcinoma. J Magn Reson Imaging. 2017 Jun;45(6):1648-1658. doi: 10.1002/jmri.25521. Epub 2016 Oct 20.
citation: Seror O, N'Kontchou G, Nault JC, Rabahi Y, Nahon P, Ganne-Carrie N, Grando V, Zentar N, Beaugrand M, Trinchet JC, Diallo A, Sellier N. Hepatocellular Carcinoma within Milan Criteria: No-Touch Multibipolar Radiofrequency Ablation for Treatment-Long-term Results. Radiology. 2016 Aug;280(2):611-21. doi: 10.1148/radiol.2016150743. Epub 2016 Mar 24.