Korpan N N
International Institute of Cryosurgery, Vienna, Austria.
Ann Surg. 1997 Feb;225(2):193-201. doi: 10.1097/00000658-199702000-00007.
The aim of this prospective study was to evaluate the applicability of cryogenic and conventional surgery in treating liver metastases (LM) with respect to intraoperative tumor reduction and survival rate.
As have been shown in animal experiments as well as in clinical investigations, cryosurgery has been used for the treatment of many benign and malignant conditions. For the first time, this report summarizes a 10-year follow-up clinical experience with cryosurgery for treatment of LM from 1983 to 1992.
One hundred twenty-three patients with LM (87 males and 36 females, a ratio 2.4:1.0; age, 41.3 +/- 12.1 years) were stratified and entered into a long-term prospective, randomized clinical trial for cryogenic surgery in group 1 (n = 63) and conventional surgical techniques in group 2 (control subjects, n = 60). Principally, a self-constructed cryogenic clamp was used for hepatic cryoresection with preliminary freezing of the margin resection by a cryosurgical system "Cryoelectronic-2" or "Cryoelectronic-4". Hepatic cryoextirpation (cryoablation) and hepatic cryodestruction were performed by means of probes of different roughly disk design from phi 5 mm to 55 mm by volume of frozen zone of 40 cm3 to 180 cm3 for approximately 7 to 32 minutes.
In most cases in group 1 and group 2, LM were based on colorectal cancers (65% vs. 68%). The hepatic cryosurgical procedures in group 1 included cryoextirpation (29 patients, 46%), cryoresection (20 patients, 32%), and cryodestruction (14 patients, 22%) solely. Clinical and laboratory parameters showed that the curative effects were significantly higher in group 1 than in group 2. The 3-year survival rate was in group 1 and group 2 (60% vs. 51%, respectively). The 5-year survival rate was 44% in group 1 and 36% in group 2. Twelve patients (19%) versus 5 patients (8%) in group 1 and group 2, respectively, survived 10 years. The disease-free survival was in group 1 and group 2 (30% vs. 18%, respectively). During a follow-up period, recurrence in the liver was observed in 54 patients (85%) in group 1 and in 57 patients (95%) in control subjects. After a 10-year follow-up period in group 1 and group 2, 9 patients (14%) versus 3 patients (5%) remained disease free, 3 patients (4%) versus 2 patients (3%) were surviving with disease, and 51 patients (81%) versus 55 patients (92%) died.
The data of this 10-year prospective, randomized clinical trial suggest that hepatic cryosurgery is effective in the treatment of resectable and nonresectable LM. The results show intraoperative tumor reduction (> or = 90% < or = 97%) and extended higher survival in these patients. The study indicated a 5-year and 10-year survival rate of 44% and 19% after cryosurgery, respectively.
本前瞻性研究旨在评估冷冻手术和传统手术在治疗肝转移瘤(LM)方面在术中肿瘤缩小和生存率方面的适用性。
正如在动物实验以及临床研究中所显示的,冷冻手术已被用于治疗多种良性和恶性疾病。本报告首次总结了1983年至1992年期间冷冻手术治疗LM的10年随访临床经验。
123例LM患者(87例男性和36例女性,比例为2.4:1.0;年龄,41.3±12.1岁)被分层并进入一项长期前瞻性随机临床试验,第1组(n = 63)接受冷冻手术,第2组(对照组,n = 60)接受传统手术技术。原则上,使用自行构建的冷冻夹进行肝脏冷冻切除,通过“Cryoelectronic - 2”或“Cryoelectronic - 4”冷冻手术系统对切缘进行初步冷冻。肝脏冷冻摘除(冷冻消融)和肝脏冷冻破坏通过不同大致盘状设计的探头进行,探头直径从5毫米到55毫米,冷冻区体积从40立方厘米到180立方厘米,持续约7至32分钟。
在第1组和第2组的大多数病例中,LM均源于结直肠癌(分别为65%和68%)。第1组的肝脏冷冻手术程序仅包括冷冻摘除(29例患者,46%)、冷冻切除(20例患者,32%)和冷冻破坏(14例患者,22%)。临床和实验室参数显示,第1组的治疗效果明显高于第2组。第1组和第2组的3年生存率分别为60%和51%。第1组的5年生存率为44%,第2组为36%。第1组和第2组分别有12例患者(19%)和5例患者(8%)存活10年。无病生存率在第1组和第2组分别为30%和18%。在随访期间,第1组54例患者(8出)和对照组57例患者(95%)出现肝脏复发。在第1组和第2组进行10年随访后,9例患者(14%)和3例患者(5%)仍无疾病,3例患者(4%)和2例患者(3%)带瘤存活,51例患者(81%)和55例患者(92%)死亡。
这项10年前瞻性随机临床试验的数据表明,肝脏冷冻手术在治疗可切除和不可切除的LM方面是有效的。结果显示这些患者术中肿瘤缩小(≥90%≤97%)且生存期延长。该研究表明冷冻手术后5年和10年生存率分别为44%和19%。