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电凝术治疗肝转移瘤。

Electrocoagulation for liver metastases.

机构信息

Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics, Jagiellonian University Medical College, Krakow, Poland.

Kleijnen Systematic Reviews Ltd, York, UK.

出版信息

Cochrane Database Syst Rev. 2021 Jan 28;1(1):CD009497. doi: 10.1002/14651858.CD009497.pub3.

Abstract

BACKGROUND

Primary liver tumours and liver metastases from colorectal carcinoma are two of the most common malignant tumours to affect the liver. The liver is second only to the lymph nodes as the most common site for metastatic disease. More than half of the people with metastatic liver disease will die from metastatic complications. Electrocoagulation by diathermy is a method used to destroy tumour tissue, using a high-frequency electric current generating high temperatures, applied locally with an electrode (needle, blade, or ball). The objective of this method is to destroy the tumour completely, if possible, in a single session. With the time, electrocoagulation by diathermy has been replaced by other techniques, but the evidence is unclear.

OBJECTIVES

To assess the beneficial and harmful effects of electrocoagulation by diathermy, administered alone or with another intervention, versus no intervention, other ablation methods, or systemic treatments in people with liver metastases.

SEARCH METHODS

We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, LILACS, Science Citation Index Expanded, Conference Proceedings Citation Index - Science, CINAHL, ClinicalTrials.gov, ICTRP, and FDA to October 2020.

SELECTION CRITERIA

We considered all randomised trials that assessed beneficial and harmful effects of electrocoagulation by diathermy, administered alone or with another intervention, versus comparators, in people with liver metastases, regardless of the location of the primary tumour.

DATA COLLECTION AND ANALYSIS

We used standard methodological procedures expected by Cochrane. We assessed risk of bias of the included trial using predefined risk of bias domains, and presented the review results incorporating the certainty of the evidence using GRADE.

MAIN RESULTS

We included one randomised clinical trial with 306 participants (175 males; 131 females) who had undergone resection of the sigmoid colon, and who had five or more visible and palpable hepatic metastases. The diagnosis was confirmed by histological assessment (biopsy) and by carcinoembryonic antigen (CEA) level. The trial was conducted in Iraq. The age of participants ranged between 38 and 79 years. The participants were randomised to four different study groups. The liver metastases were biopsied and treated (only once) in three of the groups: 75 received electrocoagulation by diathermy alone, 76 received electrocoagulation plus allopurinol, 78 received electrocoagulation plus dimethyl sulphoxide. In the fourth intervention group, 77 participants functioning as controls received a vehicle solution of allopurinol 5 mL 4 x a day by mouth; the metastases were left untouched. The status of the liver and lungs was followed by ultrasound investigations, without the use of a contrast agent. Participants were followed for five years. The analyses are based on per-protocol data only analysing 223 participants. We judged the trial to be at high risk of bias. After excluding 'nonevaluable patients', the groups seemed comparable for baseline characteristics. Mortality due to disease spread at five-year follow-up was 98% in the electrocoagulation group (57/58 evaluable people); 87% in the electrocoagulation plus allopurinol group (46/53 evaluable people); 86% in the electrocoagulation plus dimethyl sulphoxide group (49/57 evaluable people); and 100% in the control group (55/55 evaluable people). We observed no difference in mortality between the electrocoagulation alone group versus the control group (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.94 to 1.03; 113 participants; very low-certainty evidence). We observed lower mortality in the electrocoagulation combined with allopurinol or dimethyl sulphoxide group versus the control group (RR 0.87, 95% CI 0.80 to 0.95; 165 participants; low-certainty evidence). We are very uncertain regarding post-operative deaths between the electrocoagulation alone group versus the control group (RR 1.03, 95% CI 0.07 to 16.12; 152 participants; very low-certainty evidence) and between the electrocoagulation combined with allopurinol or dimethyl sulphoxide groups versus the control group (RR 1.00, 95% CI 0.09 to 10.86; 231 participants; very low-certainty evidence). The trial authors did not report data on number of participants with other adverse events and complications, recurrence of liver metastases, time to progression of liver metastases, tumour response measures, and health-related quality of life. Data on failure to clear liver metastases were not provided for the control group. There was no information on funding or conflict of interest. We identified no ongoing trials.

AUTHORS' CONCLUSIONS: The evidence on the beneficial and harmful effects of electrocoagulation alone or in combination with allopurinol or dimethyl sulphoxide in people with liver metastases is insufficient, as it is based on one randomised clinical trial at low to very low certainty. It is very uncertain if there is a difference in all-cause mortality and post-operative mortality between electrocoagulation alone versus control. It is also uncertain if electrocoagulation in combination with allopurinol or dimethyl sulphoxide may result in a slight reduction of all-cause mortality in comparison with a vehicle solution of allopurinol (control). It is very uncertain if there is a difference in post-operative mortality between the electrocoagulation combined with allopurinol or dimethyl sulphoxide group versus control. Data on other adverse events and complications, failure to clear liver metastases or recurrence of liver metastases, time to progression of liver metastases, tumour response measures, and health-related quality of life were most lacking or insufficiently reported for analysis. Electrocoagulation by diathermy is no longer used in the described way, and this may explain the lack of further trials.

摘要

背景

原发性肝肿瘤和结直肠癌肝转移是最常见的两种影响肝脏的恶性肿瘤。肝脏是仅次于淋巴结的最常见的转移部位。超过一半的转移性肝疾病患者将死于转移性并发症。电热凝固术是一种利用高频电流产生高温的方法,通过电极(针、刀片或球)局部应用来破坏肿瘤组织。该方法的目的是尽可能在一次治疗中完全破坏肿瘤。随着时间的推移,电热凝固术已被其他技术所取代,但证据尚不清楚。

目的

评估在肝转移患者中,单独使用或与其他干预措施联合使用电热凝固术与不干预、其他消融方法或全身治疗相比的有益和有害效果。

检索方法

我们检索了 Cochrane 肝胆组对照试验注册库、CENTRAL、MEDLINE Ovid、Embase Ovid、LILACS、科学引文索引扩展版、会议论文引文索引-科学、CINAHL、ClinicalTrials.gov、ICTRP 和 FDA,截至 2020 年 10 月。

选择标准

我们考虑了所有评估单独使用或与其他干预措施联合使用电热凝固术与比较剂在肝转移患者中的有益和有害效果的随机临床试验,无论原发肿瘤的位置如何。

数据收集和分析

我们使用了预期的 Cochrane 标准方法学程序。我们使用预先定义的偏倚风险领域评估纳入试验的偏倚风险,并通过 GRADE 呈现包含证据确定性的综述结果。

主要结果

我们纳入了一项随机临床试验,该试验共纳入了 306 名参与者(男性 175 名,女性 131 名),他们接受了乙状结肠切除术,并且有 5 个或更多可见和可触及的肝转移灶。诊断通过组织学评估(活检)和癌胚抗原(CEA)水平得到确认。该试验在伊拉克进行。参与者的年龄在 38 岁至 79 岁之间。参与者被随机分配到四个不同的研究组。三组中的 75 人接受了电热凝固术单独治疗,76 人接受了电热凝固术加别嘌醇治疗,78 人接受了电热凝固术加二甲基亚砜治疗。在第四组干预组中,77 名作为对照的参与者每天口服 5 毫升 4 次的别嘌醇 5 毫升溶液;转移物未被触及。通过不使用对比剂的超声检查来随访肝脏和肺部的情况。参与者随访五年。分析基于仅分析 223 名参与者的方案数据。我们认为该试验存在很高的偏倚风险。在排除“无法评估的患者”后,各组在基线特征方面似乎具有可比性。五年随访时,因疾病扩散导致的死亡率在电热凝固组为 98%(57/58 名可评估患者);在电热凝固加别嘌醇组为 87%(46/53 名可评估患者);在电热凝固加二甲基亚砜组为 86%(49/57 名可评估患者);在对照组为 100%(55/55 名可评估患者)。我们没有观察到电热凝固术单独治疗组与对照组之间的死亡率有差异(风险比(RR)0.98,95%置信区间(CI)0.94 至 1.03;113 名参与者;极低确定性证据)。我们观察到电热凝固术联合别嘌醇或二甲基亚砜治疗组与对照组相比,死亡率较低(RR 0.87,95%CI 0.80 至 0.95;165 名参与者;低确定性证据)。我们非常不确定电热凝固术单独治疗组与对照组之间(RR 1.03,95%CI 0.07 至 16.12;152 名参与者;极低确定性证据)和电热凝固术联合别嘌醇或二甲基亚砜组与对照组之间(RR 1.00,95%CI 0.09 至 10.86;231 名参与者;极低确定性证据)的术后死亡情况。试验作者没有报告其他不良事件和并发症、肝转移复发、肝转移进展时间、肿瘤反应测量和健康相关生活质量的数据。对照组未提供未能清除肝转移的数据。没有关于资金或利益冲突的信息。我们没有发现正在进行的试验。

作者结论

基于一项随机临床试验,其证据质量为低至非常低,关于单独使用电热凝固术或联合使用别嘌醇或二甲基亚砜治疗肝转移患者的有益和有害效果的证据不足。我们非常不确定电热凝固术单独治疗组与对照组之间的全因死亡率和术后死亡率是否存在差异。我们也不确定电热凝固术联合别嘌醇或二甲基亚砜治疗组与对照组相比,是否可能导致全因死亡率略有降低。我们非常不确定电热凝固术联合别嘌醇或二甲基亚砜治疗组与对照组相比,术后死亡率是否存在差异。其他不良事件和并发症、未能清除肝转移或肝转移复发、肝转移进展时间、肿瘤反应测量和健康相关生活质量的数据最为缺乏或报告不足,无法进行分析。电热凝固术已不再以描述的方式使用,这可能解释了为什么没有进一步的试验。

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