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Purpose <p>To compare the efficacy of ultrasound-guided alcohol sclerotherapy versus laparoscopic cystectomy for the management of ovarian endometriomas, focusing on complications, recurrence, pain relief, and healthcare costs.</p> Methods <p>We conducted a multicentre, randomized clinical trial across 20 centers in Spain. A total of 167 women aged 18–40&#xa0;years with ovarian endometriomas (35–100&#xa0;mm) were recruited between June 2018 and June 2022. Participants were randomized to receive either ultrasound-guided aspiration with ethanol sclerotherapy or standard laparoscopic cystectomy. Complications were graded using the Clavien–Dindo classification. Pain was assessed using a visual analogue scale (VAS) before and six months after treatment. Recurrence was defined as the reappearance of a cystic lesion at the treated site and analyzed using Kaplan–Meier curves and log-rank tests. The primary analysis followed an <i>intention-to-treat</i> approach and included 158 patients (sclerotherapy: <i>n</i> = 84; cystectomy: <i>n</i> = 74). The <i>per-protocol</i> analysis included 92 patients (sclerotherapy: <i>n</i> = 57; cystectomy: <i>n</i> = 37). Direct hospital costs, complication rates, recurrence, and pain relief were compared between groups.</p> Results <p>Intention-to-treat analyses show that complications were low in both groups (12%), most of which were Grade I–II, although 4.1% were Grade III in the surgery group. The cost of sclerotherapy was significantly lower (€472 vs. €2128, <i>p</i> &lt; 0.001). In per-protocol analyses, the cyst recurrence or reappearance was similar between the two groups, with rates of 25.7% (9 of 35) in the surgery group and 22.8% (13 of 57) in the sclerotherapy group (<i>p</i> = 0.16). Pain was improved or completely resolved in 49 of 55 cases (89.1%) in the sclerotherapy group and in 21 of 32 cases (65.7%) in the laparoscopic surgery group (<i>p</i> = 0.05).</p> Conclusions <p>Ultrasound-guided alcohol sclerotherapy is a safe, cost-effective alternative to laparoscopic cystectomy for the treatment of endometriomas, with comparable recurrence rates and pain relief. Clinical Trial Registration: <a href="https://clinicaltrials.gov/search?term=NCT03571776">https://clinicaltrials.gov/search?term=NCT03571776</a>. Registered May 5, 2018.</p>

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Ultrasound-guided ethanol sclerotherapy versus laparoscopic surgery for endometriomas: a randomized clinical trial in a real-world setting

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  • 发表日期：

    2025年11月4日

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  • Amparo García-Tejedor,
  • Rodrigo Guevara-Peralta,
  • Jose Manuel Martinez-Garcia,
  • Shiana Corbalán,
  • Mauricio Agüero,
  • Maria Gomez-Romero,
  • Marta Cararach,
  • Marta Castellarnau,
  • Mariví Rodríguez,
  • Ana Cristina Lou-Mercadé,
  • Laura Costa,
  • Maria Jose Rodríguez,
  • Eva Huguet,
  • Manuel Carreras,
  • Ana Belen Castel-Segui,
  • Maria Font-Roig,
  • Susana Royo,
  • Nuria Sarasa,
  • Beatriz Candas,
  • Samuel Perez-Carton,
  • Carlos Ortega,
  • Maria Jesus Pla,
  • Jordi Ponce

摘要

Purpose

To compare the efficacy of ultrasound-guided alcohol sclerotherapy versus laparoscopic cystectomy for the management of ovarian endometriomas, focusing on complications, recurrence, pain relief, and healthcare costs.

Methods

We conducted a multicentre, randomized clinical trial across 20 centers in Spain. A total of 167 women aged 18–40 years with ovarian endometriomas (35–100 mm) were recruited between June 2018 and June 2022. Participants were randomized to receive either ultrasound-guided aspiration with ethanol sclerotherapy or standard laparoscopic cystectomy. Complications were graded using the Clavien–Dindo classification. Pain was assessed using a visual analogue scale (VAS) before and six months after treatment. Recurrence was defined as the reappearance of a cystic lesion at the treated site and analyzed using Kaplan–Meier curves and log-rank tests. The primary analysis followed an intention-to-treat approach and included 158 patients (sclerotherapy: n = 84; cystectomy: n = 74). The per-protocol analysis included 92 patients (sclerotherapy: n = 57; cystectomy: n = 37). Direct hospital costs, complication rates, recurrence, and pain relief were compared between groups.

Results

Intention-to-treat analyses show that complications were low in both groups (12%), most of which were Grade I–II, although 4.1% were Grade III in the surgery group. The cost of sclerotherapy was significantly lower (€472 vs. €2128, p < 0.001). In per-protocol analyses, the cyst recurrence or reappearance was similar between the two groups, with rates of 25.7% (9 of 35) in the surgery group and 22.8% (13 of 57) in the sclerotherapy group (p = 0.16). Pain was improved or completely resolved in 49 of 55 cases (89.1%) in the sclerotherapy group and in 21 of 32 cases (65.7%) in the laparoscopic surgery group (p = 0.05).

Conclusions

Ultrasound-guided alcohol sclerotherapy is a safe, cost-effective alternative to laparoscopic cystectomy for the treatment of endometriomas, with comparable recurrence rates and pain relief. Clinical Trial Registration: https://clinicaltrials.gov/search?term=NCT03571776. Registered May 5, 2018.