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

NCT07004959 | Recruiting

• 1 other identifier: RCAPHM20_0429
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Difference in the number of millimetres of VAS for pain between the preoperative consultation and the consultation one year after the operation

  The main objective is to investigate the non-inferiority of sclerotherapy of endometriomas one year after the operation in terms of reduction of painful symptoms compared with laparoscopic cystectomy. The reduction in painful symptoms was defined by the difference in the number of millimetres of VAS for pain between the preoperative consultation and the consultation one year after the operation, according to the answer to the question : " Indicate the subjective level of your endometriosis-related pain over the last 4 weeks by simply drawing a line through the line".

  At 12 months

Secondary Outcomes (8)

• Pain components

  At 3 and 12 months

• Subjective improvement

  At 3 and 12 months

• Patient satisfaction

  At 3 months

• Reccurence rate

  At 12 months

• Pregnancy rate

  At 12 months

Study Arms (2)

Sclerotherapy

EXPERIMENTAL

Procedure: Vaginal ultrasound-guided ethanol sclerotherapy

Intraperitoneal cystectomy

ACTIVE COMPARATOR

Procedure: Laparoscopic cystectomy

Interventions

Vaginal ultrasound-guided ethanol sclerotherapy PROCEDURE

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.

Sclerotherapy

Laparoscopic cystectomy PROCEDURE

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).

Intraperitoneal cystectomy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18 and 45
• Endometrioma diagnosed by endovaginal ultrasound or MRI (examinations carried out by a radiologist or gynaecologist) with a typical appearance and whose largest diameter is between 3 and 10 centimetres.
• Pain (dysmenorrhoea or chronic pelvic pain) with a VAS greater than 30 millimetres, assessed by the question "Indicate the subjective level of your endometriosis-related pain over the last 4 weeks".

You may not qualify if:

• Inability to speak French
• Refusal to take part in the study
• Risk factors for impaired ovarian reserve:
• Ovarian reserve already low (AMH \<1,5ng/ml or Antral follicle count \< 7 on the contralateral ovary
• Bilateral or multiple endometriomas (two or more endometriomas greater than 3 centimetres in diameter).
• Previous cystectomy
• Previous major peritoneal surgery causing adhesions.
• Contraindication to sclerotherapy : allergy to ethanol
• Contraindications to general anaesthesia
• Pregnant women, women in labour and nursing mothers

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

gynecology department APHM

Marseille, France, 13005, France

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Antoine NETTER

  Assistance Publique - Hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire MORANDO

CONTACT

0491382183; claire.morando@ap-hm.fr ; promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: November 19, 2024
• Primary Completion (Estimated): March 19, 2028
• Study Completion (Estimated): March 19, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)