Department of Obstetrics Gynecology and Reproductive Medicine, Pôle femmes parents enfants, La Conception University Hospital, Marseille, France.
Department of Mediterranean Institute of marine and terrestrial Biodiversity and Ecology, Aix Marseille Univ, Avignon Université, CNRS, IRD, IMBE, Marseille, France.
Hum Reprod. 2024 Apr 3;39(4):733-741. doi: 10.1093/humrep/deae014.
What are the complications of transvaginal ethanol sclerotherapy for the treatment of endometriomas?
Sclerotherapy is a reliable, minimally invasive method applicable in outpatient procedures but with specific and potential life-threatening complications that need to be identified and prevented.
There are currently few data on the use of transvaginal ethanol sclerotherapy, and we mainly note septic complications.
STUDY DESIGN, SIZE, DURATION: A retrospective observational cohort study was carried out. The study was conducted at an academic hospital and included 126 women aged 31.9 ± 5.5 years (mean ± SD), between November 2013 and June 2021. We analyzed a total of 157 ethanol sclerotherapy treatment (EST), treated by 131 EST procedures, in 126 women.
PARTICIPANTS/MATERIALS, SETTING, METHODS: The study included women with an indication for transvaginal ethanol sclerotherapy. Indications were women with at least one endometrioma over 10 mm, isolated or associated with other endometriosis locations, requiring treatment for pain or infertility before assisted reproductive treatment. We followed a standardized transvaginal ethanol sclerotherapy procedure consisting of an ultrasound-guided transvaginal puncture of one or more endometriomas under general anesthesia. The cyst content was completely removed and flushed with saline solution. Ethanol (96%) was injected at 60% of the initial volume of the endometrioma, remained in the cyst for 10 min and was then completely removed. Ethanol loss was defined as a loss of 5 ml or more than 10% of the initial volume of the injected ethanol. Failure was defined by the contraindication of endometrioma puncture because of interposition of the digestive tract, ethanol loss in the previous endometrioma treated (in case of multiple ESTs), failure to aspirate the endometriotic fluid, contraindication to start ethanol injection owing to saline solution leakage, or contraindication to continue ethanol injection owing to suspicions of ethanol leakage at sonography. Intraoperative complications were defined by ethanol loss, positive blood alcohol level, and ethanol intoxication. Postoperative complications were defined by fever, biological inflammatory syndrome, and ovarian abscess. Complications were classified according to the Clavien and Dindo surgical classification, which is a system for classifying postoperative complications in five grades of increasing severity.
We reported a total of 17/157 (10.8%) transvaginal ethanol sclerotherapy failures during 14/131 (10.7%) transvaginal ethanol sclerotherapy procedures in 13/126 (10.3%) women. In the same sets of data, complication was reported for 15/157 (9.5%) transvaginal ethanol sclerotherapy in 13/131 (9.9%) transvaginal ethanol sclerotherapy procedures in 13/126 (10.3%) women. Nine of 126 women (7.1%) had a grade I complication, one (0.8%) had a grade II complication (medical treatment for suspicion of pelvic infection), two (1.6%) had a grade III complication (ovarian abscess) and one (0.8%) had a grade IV complication (ethanol intoxication). We did not observe any grade V complications.
LIMITATIONS, REASONS FOR CAUTION: This was a retrospective study and pain assessment not considered. The benefit-risk balance of endometrioma transvaginal ethanol sclerotherapy was not evaluated.
Our study is the first to evaluate the complications of transvaginal ethanol sclerotherapy with such a large cohort of women in a standardized protocol. Transvaginal ethanol sclerotherapy seems to be an effective alternative to laparoscopic surgery in the management of endometriomas and limits the alteration of ovarian reserve. Transvaginal ethanol sclerotherapy is a reliable, minimally invasive method applicable on an outpatient basis. The majority of complications are Clavien-Dindo ≤IV, for which preventative measures, or at least early diagnosis and treatment, can be easily performed. The risk of ethanol intoxication is rare, but it is a life-threatening risk that must be avoided by appropriate implementation and promotion of the sclerotherapy procedures.
STUDY FUNDING/COMPETING INTEREST(S): None.
Aix Marseille University's ethics committee registration number 2021-06-03-01.
经阴道乙醇硬化疗法治疗卵巢子宫内膜异位囊肿的并发症有哪些？
硬化疗法是一种可靠的、微创的方法，适用于门诊手术，但存在特定且潜在危及生命的并发症，需要识别和预防。
目前关于经阴道乙醇硬化疗法的应用数据较少，我们主要注意到感染性并发症。
研究设计、规模、持续时间：这是一项回顾性观察队列研究。该研究在一家学术医院进行，纳入了 2013 年 11 月至 2021 年 6 月期间的 126 名年龄为 31.9±5.5 岁的女性。我们分析了 131 例经阴道乙醇硬化疗法（EST）治疗的 157 例治疗（EST），共 126 名女性。
参与者/材料、设置、方法：该研究纳入了有经阴道乙醇硬化疗法治疗指征的女性。适应证为至少有一个 10mm 以上的卵巢子宫内膜异位囊肿，孤立或伴有其他子宫内膜异位症部位，在接受辅助生殖治疗前需要治疗疼痛或不孕。我们遵循标准化的经阴道乙醇硬化疗法程序，包括在全身麻醉下经阴道超声引导下穿刺一个或多个子宫内膜异位囊肿。排空囊肿内容物，并用生理盐水冲洗。将 96%的乙醇以初始卵巢子宫内膜异位囊肿体积的 60%注入，在囊肿内保留 10 分钟，然后完全排空。乙醇损失定义为损失 5ml 或以上初始注入乙醇体积的 10%。失败定义为由于消化道介入而无法穿刺卵巢子宫内膜异位囊肿、先前治疗的（如果进行多次 EST）卵巢子宫内膜异位囊肿乙醇损失、无法吸出子宫内膜异位性液体、由于生理盐水泄漏而开始乙醇注射的禁忌、或由于超声怀疑乙醇泄漏而继续乙醇注射的禁忌。术中并发症定义为乙醇损失、血乙醇水平阳性和乙醇中毒。术后并发症定义为发热、生物炎症综合征和卵巢脓肿。并发症根据 Clavien 和 Dindo 外科分类进行分类，这是一种用于分类术后并发症的系统，分为五个严重程度递增的等级。
我们报告了在 131 例经阴道乙醇硬化疗法（EST）治疗中（10.7%）的 14 例经阴道乙醇硬化疗法（EST）治疗中（10.3%）的 13 例（10.3%）女性中，共有 17/157（10.8%）的经阴道乙醇硬化疗法（EST）失败。在同一组数据中，131 例经阴道乙醇硬化疗法（EST）中有 13 例（9.9%）发生了 15/157（9.5%）的经阴道乙醇硬化疗法（EST）并发症，126 例女性中有 13 例（10.3%）发生了并发症。126 名女性中有 9 名（7.1%）出现了 I 级并发症，1 名（0.8%）出现了 II 级并发症（疑似盆腔感染的药物治疗），2 名（1.6%）出现了 III 级并发症（卵巢脓肿），1 名（0.8%）出现了 IV 级并发症（乙醇中毒）。我们没有观察到任何 V 级并发症。
局限性、谨慎的原因：这是一项回顾性研究，未考虑疼痛评估。未评估卵巢子宫内膜异位囊肿经阴道乙醇硬化疗法的获益风险平衡。
我们的研究首次在标准化方案中使用如此大量的女性队列评估经阴道乙醇硬化疗法的并发症。经阴道乙醇硬化疗法似乎是治疗卵巢子宫内膜异位囊肿的腹腔镜手术的有效替代方法，可限制卵巢储备的改变。经阴道乙醇硬化疗法是一种可靠的、微创的方法，适用于门诊手术。大多数并发症为 Clavien-Dindo≤IV，可采取预防措施，或至少早期诊断和治疗。乙醇中毒的风险罕见，但它是一种危及生命的风险，必须通过适当的实施和推广硬化疗法来避免。
研究经费/利益冲突：无。
艾克斯马赛大学伦理委员会注册号 2021-06-03-01。
