Clinical trial NCT02822053: Effectivity and Safety of Ultrasound-guided Percutaneously Laser Ablation for Refractory Neoplasms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Refractory Neoplasms
Keywords: Ultrasonography-guided Laser Ablation
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of ultrasonography (US) -guided laser ablation liver, kidney, pancreas, lung and retroperitoneal tumors, the investigators used preoperative and postoperative US/CEUS/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 ≥ 50\*10E9/L and PT ≤ 20s.

Exclusion Criteria:

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

Primary outcomes:
measure: 100 patients of refractory neoplasms with image-guided laser ablation-related effectivity as assessed by MRI
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References:
citation: Francica G, Petrolati A, Di Stasio E, Pacella S, Stasi R, Pacella CM. Influence of ablative margin on local tumor progression and survival in patients with HCC </=4 cm after laser ablation. Acta Radiol. 2012 May 1;53(4):394-400. doi: 10.1258/ar.2012.110471. Epub 2012 Mar 5.
citation: Wu X, Zhou P, Ma S, Tian S, Deng J, Zhao Y. [Ultrasound-guided laser thermal ablation for treatment of small liver cancer at high-risk sites]. Nan Fang Yi Ke Da Xue Xue Bao. 2016 Jan;36(1):120-5. Chinese.
citation: Di Costanzo GG, D'Adamo G, Tortora R, Zanfardino F, Mattera S, Francica G, Pacella CM. A novel needle guide system to perform percutaneous laser ablation of liver tumors using the multifiber technique. Acta Radiol. 2013 Oct;54(8):876-81. doi: 10.1177/0284185113489825. Epub 2013 May 23.
citation: Zou X, Liu Q, Zhou X, He G, Yu M, Han Z, Meng X, Su H. Ultrasound-guided percutaneous laser and ethanol ablation of rabbit VX2 liver tumors. Acta Radiol. 2013 Mar 1;54(2):181-7. doi: 10.1258/ar.2012.110723.
citation: Clements LW, Collins JA, Weis JA, Simpson AL, Adams LB, Jarnagin WR, Miga MI. Evaluation of model-based deformation correction in image-guided liver surgery via tracked intraoperative ultrasound. J Med Imaging (Bellingham). 2016 Jan;3(1):015003. doi: 10.1117/1.JMI.3.1.015003. Epub 2016 Mar 23.
citation: Jiang T, Deng Z, Tian G, Chen F, Bao H, Li J, Wang W. Percutaneous laser ablation: a new contribution to unresectable high-risk metastatic retroperitoneal lesions? Oncotarget. 2017 Jan 10;8(2):2413-2422. doi: 10.18632/oncotarget.13897.