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Non-inferiority Trial Comparing Vaginal Ultrasound-guided Ethanol Sclerotherapy and Laparoscopic Cystectomy for the Management of Ovarian Endometriomas (E-STEP)

NCT07004959 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-06-04

No results posted yet for this study

Summary

Endometriosis is a disease that affects between 6 and 10% of women of childbearing age. It is defined by the presence of endometrial tissue outside the uterine cavity, most often in the ovaries or the peritoneal cavity.

The standard treatment for endometriomas is laparoscopic intraperitoneal cystectomy. This treatment has been shown to be associated with a lower rate of recurrence of painful symptoms than simple cyst drainage, and with higher pregnancy rates. Nevertheless, cystectomy can lead to a reduction in ovarian reserve due to the removal of adjacent healthy ovarian tissue, particularly when there is no cleavage plane between the ovary and the endometrioma.

Other methods have been developed to manage endometriomas while preserving the ovarian reserve. Endometrioma sclerotherapy is one of the most promising techniques for reducing the risk of recurrence while preserving the ovarian reserve. This technique involves injecting a sclerosing agent into the cystic cavity, which has been drained beforehand, in order to create an abrasion of the cystic epithelium, resulting in inflammation and fibrosis that can lead to the permanent destruction of the cyst.

The aim of the study is to conduct a single-centre randomised controlled non-inferiority trial comparing sclerotherapy and intraperitoneal cystectomy for the treatment of endometriomas.

The main hypothesis of the study is that sclerotherapy is not inferior to cystectomy in terms of reducing painful symptoms one year after the operation and that it is superior to cystectomy on one or more of the following criteria: preservation of ovarian reserve, operative complications, post-operative pain, patient acceptability/satisfaction.

The number of patients to be included will be 64, calculated to demonstrate non-inferiority between sclerotherapy and cystectomy for the primary endpoint.

Conditions

  • Ovarian Endometrioma

Interventions

PROCEDURE

Vaginal ultrasound-guided ethanol sclerotherapy

Use of an endovaginal ultrasound probe combined with a puncture guide. The technique involves locating the endometriosis cyst, echo-guided drainage via the endovaginal route, sclerotherapy (replacement of 60% of the punctured volume with 95% ethanol left in place for 10 minutes) and then reaspiration of the ethanol.

PROCEDURE

Laparoscopic cystectomy

Conventional laparoscopy, with the laparoscope introduced through a 10mm incision at the umbilicus, and the laparoscopic instruments used through two or three 5mm incisions (suprapubic and right and left fossa iliaca). The surgical technique may vary according to the patient and the surgeon's preferences or habits, but must necessarily include a cystectomy (cyst wall sent for anatomopathology).

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Antoine NETTER · Assistance Publique - Hôpitaux de Marseille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2028-03-19
Completion
2028-03-19

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07004959 on ClinicalTrials.gov