Clinical Trials Study
Copyright ©2014 Baishideng Publishing Group Inc.
World J Gastroenterol. Jul 28, 2014; 20(28): 9570-9577
Published online Jul 28, 2014. doi: 10.3748/wjg.v20.i28.9570
Table 1 Patient characteristics
Number of cases30
Age (yr)64.3 ± 1.5 SD
Sex (M/F)9/11
Performance status (0/1/2/3/4)18/8/ 3/1/0
Location (head/uncus/body/tail/others)13/4/9/1/ 3
Mean tumor size (mm)31.67 ± 1.7 SD
Pre-therapy (operation/chemotherapy/radiation/IVR/BSC)3/28/4/5/1
M: Male; F: Female; IVR: Interventional radiology; BSC: Best supportive care.
Table 2 Clinical data n (%)
Mean number of procedures (range)2.7 ± 0.1 SD
Mean total therapeutic time (h) per case (range)2.4 ± 0.1 SD
Rate of complete tumor ablation24/30 (80)
Rate of anesthesia/sedation administered0/30 (0)
Rate of pain killer administered1/30 (3.3)
Table 3 Therapeutic effects
Rate of pain relief effect1 (%)16/21 (66.7)
Rate of clinical benefit2 (%)22/30 (73.3)
Rate of usefulness of evaluation after HIFU22/30 (73.3)
using CE-US and/or CT/PET3 (%)
Rate of half reduction in CA19-9 level (%)3/14 (21)
Mean tumor size (mm)30.9 ± 1.7 SD
Efficacy of primary lesion (CR/PR/SD/PD)0/4/22/4
Therapy after HIFU (operation/chemotherapy/radiation/BSC)2/24/0/4
Adverse events4 (%)3/30 (10)
1“Effective” indicates a more than 30% improvement in pain relief;
2“Effective” was based on the patient’s declaration about appetite, fatigue, sleep, and weight. Pain: 16/21 (66.7%), appetite; 4/30 (13.3%), fatigue; 2/30 (6.7%), sleep; 8/30 (26.7%), weight; 2/30 (6.7%);
3CE-US: 18/30 (60%); CT: 10/30 (33%); MRI: 3/30 (10%); PET: 2/30 (6.7%);
4Pancreatic pseudocyst 2 cases → ECD and observed pancreatitis 1 case (after 2 wk and past history of pancreatitis). CE-US: Contrast-enhanced ultrasonography; HIFU: High-intensity focused ultrasound; CT: Computed tomography; CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease; BSC: Best supportive care; PET: Positron emission tomography.