Ultrasound-guided aspiration of cystic pelvic lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on the ultrasound-guided transvaginal aspiration of cystic pelvic lesions, particularly in premenopausal women experiencing discomfort from adnexal cysts or pelvic abscesses. The study aims to evaluate the effectiveness of this minimally invasive procedure compared to traditional surgical methods, considering factors such as lesion characteristics and patient comorbidities. By assessing the outcomes of symptom relief and recurrence rates, the study seeks to provide insights into optimal treatment approaches for symptomatic cystic lesions with a low risk of malignancy.

Why it matters

Who can join: the full rules

Participants eligible for inclusion in this study must meet all of the following criteria:

1. Lesion criteria applicable for therapeutic intervention

   1. Safe accessibility of the lesion (within reach of aspiration needle; visible on ultrasound; transvaginal access; no interposition of bowel or blood vessels)
   2. Lesion types included: cystic lesions (adnexal cysts), pelvic inclusion cysts (pseudocysts), pelvic abscesses
2. Indications

   1. Pain relief in symptomatic cystic lesions with benign appearance.
   2. Symptomatic treatment in probably malignant lesions (only in non-curative setting).

Exclusion Criteria:

1. Patients \<18 years
2. Poor performance status contra-indicating the procedure
3. Vaginal stenosis (severe atrophy - virgo - vaginismus)
4. Purely solid lesions
5. Cystic lesions with a presumed malignant diagnosis and a risk of tumor dissemination in a curative setting
6. Physiological cysts in asymptomatic patients (in case of doubt the patient is reassessed after 3-6 months)

Where it's running

• University Hospitals Leuven
  Leuven, Vlaams-Brabant, Belgium Recruiting

Study contacts

• Study coordinator: Stefan Timmerman, MD
• Email: stefan.timmerman@uzleuven.be
• Phone: +32 16 34 47 50

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.