RecruitingNAINTERVENTIONAL

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

This research is looking into better ways to treat ovarian endometriomas, which are common cysts seen in women with endometriosis. These cysts can cause pain and sometimes make it harder to get pregnant. The usual treatment involves surgery called laparoscopic cystectomy to remove the cyst. While effective, this surgery can sometimes unintentionally remove some healthy egg-producing tissue, potentially affecting future fertility. This study is comparing that standard surgery with a newer, less invasive method called ethanol sclerotherapy. This involves draining the cyst and then injecting a special alcohol to help destroy the cyst lining. The main goal is to see if sclerotherapy is just as good as surgery at reducing pain, but with fewer risks and better at protecting the ovary's future health. We also want to know if patients prefer it.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique Hopitaux De Marseille

Enrolment target

Start

19 Nov 2024

Estimated completion

19 Mar 2028

Ovarian Endometrioma

What is this study about?

Endometriosis is a common condition where tissue similar to the lining of the womb grows outside of it, often on the ovaries. When this tissue forms cysts on the ovaries, they're called endometriomas. These cysts can cause uncomfortable symptoms like period pain, ongoing pelvic pain, or pain during sex, and sometimes make it more difficult to become pregnant.

The current standard treatment for endometriomas that cause problems is a keyhole surgery called laparoscopic cystectomy. This surgery involves carefully removing the cyst from the ovary. While it's good at reducing pain and can help with pregnancy rates, there's a small risk that the surgery might also remove some healthy ovarian tissue along with the cyst. This could potentially reduce the number of eggs a woman has, which is important for future fertility. Doctors are always looking for ways to treat these cysts effectively while protecting a woman's ovarian health as much as possible.

This study is comparing the standard surgery with a different approach called vaginal ultrasound-guided ethanol sclerotherapy. This method is less invasive and involves using an ultrasound probe, placed gently in the vagina, to guide a needle into the cyst. The fluid inside the cyst is then drained, and a small amount of pure alcohol (ethanol) is injected into the empty cyst. The ethanol helps to destroy the cells lining the cyst, which can stop it from growing back. The idea is that this method might be just as good as surgery at reducing pain, but with less risk to the ovary and potentially a quicker recovery. Researchers want to find out which treatment offers the best balance of pain relief, ovarian protection, and patient comfort.

Key takeaways

Compares standard surgery with a new, less invasive cyst treatment.
Aims to find a treatment that reduces pain and better protects fertility.
Participants will receive either standard surgery or ethanol sclerotherapy.
Study will monitor pain, ovarian health, and patient satisfaction for one year.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

To join this study, women need to be between 18 and 45 years old. You must have an endometrioma cyst on one ovary that's been diagnosed by ultrasound or MRI, and it needs to be between 3 and 10 centimetres in size. You should also be experiencing pain from your endometriosis, such as painful periods or ongoing pelvic pain, that is bothering you significantly.

There are several reasons why you might not be able to join. For example, if your ovarian reserve (the number of eggs you have left) is already quite low, or if you have multiple endometriomas or cysts on both ovaries. If you've had surgery to remove an endometrioma before, or had major abdominal surgery that caused scar tissue, you wouldn't be able to participate. You also can't join if you're pregnant, breastfeeding, or allergic to ethanol.

Since this study involves talking to doctors and nurses, you also need to be able to understand and speak French fluently. Taking part is completely voluntary, so if you don't wish to join, that's perfectly fine.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 45 years old?
Do you have a single endometrioma cyst on one ovary, between 3-10 cm?
Are you experiencing significant pelvic pain or painful periods due to endometriosis?
Have you not had previous surgery for an endometrioma?
Do you not have low ovarian reserve (measured by blood tests or scans)?
Are you not pregnant or breastfeeding, and not allergic to alcohol products?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive one of two treatments: either the standard keyhole surgery (laparoscopic cystectomy) or the less invasive ethanol sclerotherapy. Both procedures are carried out while you are asleep under general anaesthesia.

You will have check-ups to assess your pain levels, ovarian health, and overall well-being. These checks will continue for about a year after your procedure. You'll complete questionnaires about your pain and how satisfied you are with your treatment. You'll also have blood tests and ultrasound scans to monitor your ovaries.

The overall study participation, including the follow-up appointments, will last for about 12 months. You are free to withdraw from the study at any time without giving a reason.

Potential risks and benefits

You might benefit from participating in this study by potentially receiving a treatment that could reduce your pain and improve your quality of life. The sclerotherapy option is also hoped to better protect your fertility. However, as with any medical procedure, there are potential risks, though these will be fully explained by the study team. For surgery, these can include risks associated with anaesthesia and the surgery itself, such as bleeding or infection. For sclerotherapy, there's a small risk of discomfort, infection, or not fully treating the cyst. You will be closely monitored throughout the study, and if you experience any unexpected problems, the study team will provide care. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

gynecology department APHM
Verified postcode
Marseille, France· Recruiting

Common questions

What is an ovarian endometrioma?

It's a type of cyst that forms on the ovary when tissue similar to the womb lining grows outside the womb, a condition called endometriosis.

What's the main goal of this study?

To see if a less invasive treatment (ethanol sclerotherapy) is as good as standard surgery for pain relief, but better for protecting your ovarian health.

Will I get to choose which treatment I receive?

No, you'll be randomly assigned to either the surgery or the sclerotherapy group, like tossing a coin.

How long will I be followed up in the study?

You'll have appointments and checks for about a year after your treatment to see how you're doing.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any point without it affecting your medical care.

How to find out more

Claire MORANDO

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

Always speak to your GP or specialist before deciding to take part in a study.