Ultrasound-guided aspiration of cystic pelvic lesions
Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions
This study is testing if using ultrasound to drain cysts in the pelvis can help premenopausal women feel better compared to traditional surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06988280 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are premenopausal women with symptomatic cystic pelvic lesions that are accessible for aspiration.
Not a fit: Patients with purely solid lesions or those with a presumed malignant diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer patients a less invasive option for managing symptomatic cystic lesions, reducing recovery time and hospital costs.
How similar studies have performed: Other studies have shown promise in using ultrasound-guided aspiration techniques for similar conditions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Leuven, Vlaams-Brabant
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.