Bai Zhi-Bin, Qin Yong-Lin, Deng Gang, Zhao Guo-Feng, Zhong Bin-Yan, Teng Gao-Jun
Center of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing, 210009, China.
Obes Surg. 2018 Apr;28(4):907-915. doi: 10.1007/s11695-017-2979-9.
The purpose of this study is to investigate the safety and 9-month effectiveness of transcatheter left gastric artery embolization (LGAE) for treating patients with obesity.
The protocol of this study was approved by the Institutional Ethics Review Board. Five obese patients (3 men and 2 women) with mean weight of 102.0 ± 16.19 kg (range, 82.1-125.5 kg) and mean body mass index (BMI) of 38.1 kg/m ± 3.8 (range, 32.9-42.4 kg/m) underwent LGAE with polyvinyl alcohol (PVA) particles in diameter of 500-710 μm. The primary endpoint was the safety by grading the adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0) within 30 days after LGAE. The secondary endpoints were measured with serum ghrelin and leptin levels, body weight, waist circumference, waist-to-height ratio, and abdominal fat quantity on MRI at the day immediately before LGAE and every 3 months after LGAE.
LGAE was successfully performed in all patients. A superficial linear ulceration below the cardia was seen in 1 patient 3 days after LGAE and healed within 30 days. No other serious AEs (grade III or above) occurred. Average body weight loss at 3, 6, and 9 months was 8.28 ± 7.3 kg (p = 0.074), 10.42 ± 8.21 kg (p = 0.047), and 12.9 ± 14.66 kg (p = 0.121), respectively. The level of serum ghrelin decreased by 40.83% (p = 0.009), 31.94% (p = 0.107), and 24.82% (p = 0.151) at 3, 6, and 9 months after LGAE, respectively. There was minimal reduction of leptin levels at 3 and 6 months following LGAE (decreased by 0.26%, p = 0.929, and 4.33%, p = 0.427, respectively), but it declined obviously 9 months after LGAE (decreased by 11.22%, p = 0.295). Both waist circumference and waist-to-height ratio decreased after LGAE. MRI showed the area of subcutaneous adipose tissue decreased from the baseline of 400.90 ± 79.25 to 320.36 ± 68.06 cm (decreased by 20.09%, p = 0.006) at 3 months, to 328.31 ± 52.67 cm (decreased by 18.11%, p = 0.020) at 6 months, and to 286.40 ± 55.72 cm (decreased by 28.52%, p = 0.101) at 9 months after LGAE, respectively. But the decrease of abdominal fat loss at 9 months after LGAE was largely due to the reduction in visceral adipose tissue.
Our study with 9-month data in 5 patients indicates that bariatric embolization of the LGA is a safe and may be a promising strategy to suppress the production of ghrelin and results in weight loss and abdominal fat reduction.
ClinicalTrials.gov (NCT02786108).
本研究旨在探讨经导管左胃动脉栓塞术（LGAE）治疗肥胖患者的安全性及9个月的疗效。
本研究方案经机构伦理审查委员会批准。5例肥胖患者（3例男性，2例女性），平均体重为102.0±16.19 kg（范围82.1 - 125.5 kg），平均体重指数（BMI）为38.1 kg/m²±3.8（范围32.9 - 42.4 kg/m²），接受了直径为500 - 710μm的聚乙烯醇（PVA）颗粒的LGAE治疗。主要终点是根据不良事件通用术语标准（CTCAE v4.0）在LGAE后30天内对不良事件（AE）进行分级来评估安全性。次要终点在LGAE前一天及LGAE后每3个月通过测量血清胃饥饿素和瘦素水平、体重、腰围、腰高比以及MRI上的腹部脂肪量来评估。
所有患者LGAE均成功实施。1例患者在LGAE后3天出现贲门下方浅表线性溃疡，30天内愈合。未发生其他严重不良事件（III级或以上）。3、6和9个月时的平均体重减轻分别为8.28±7.3 kg（p = 0.074）、10.42±8.21 kg（p = 0.047）和12.9±14.66 kg（p = 0.121）。LGAE后3、6和9个月时血清胃饥饿素水平分别下降40.83%（p = 0.009）、31.94%（p = 0.107）和24.82%（p = 0.151）。LGAE后3和6个月时瘦素水平降低幅度极小（分别下降0.26%，p = 0.929，和4.33%，p = 0.427），但LGAE后9个月明显下降（下降11.22%，p = 0.295）。LGAE后腰围和腰高比均下降。MRI显示皮下脂肪组织面积在LGAE后3个月从基线的400.90±79.25降至320.36±68.06 cm²（下降20.09%，p = 0.006），6个月时降至328.31±52.67 cm²（下降18.11%，p = 0.020），9个月时降至286.40±55.72 cm²（下降28.52%，p = 0.101）。但LGAE后9个月腹部脂肪减少主要是由于内脏脂肪组织减少。
我们对5例患者的9个月数据研究表明，LGA的减肥栓塞术是安全的，可能是一种有前景的抑制胃饥饿素产生、导致体重减轻和腹部脂肪减少的策略。
ClinicalTrials.gov（NCT02786108）
