RecruitingNCT06988280

Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

100 participants

Start Date

Mar 13, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Adnexal cysts or pseudocysts are a common finding on transvaginal ultrasound, especially in premenopausal women. Due to the size of some cysts, they may cause discomfort. Moreover, a genuine risk of ovarian torsion presents when these lesions grow. During the last decades, great advancements have been made in the correct differentiation of benign from malignant lesions. However, there still is controversy concerning the optimal treatment approach of symptomatic adnexal cysts with a low risk of malignancy, consisting of both surgery or ultrasound-guided transvaginal aspiration. Factors such as comorbidities and lesion characteristics need to be considered when counselling patients, as well as the possibility of short term recurrence. Surgically removing them may result in longer hospital stays and recovery, with higher costs, while transvaginal needle aspiration techniques can be performed during a consultation. Additional benefits in avoiding surgery, particularly in women of reproductive age, are fertility preservation and less pelvic adhesions. On the other hand, the main arguments against cyst aspiration are the relatively high recurrence rate of cysts, the minimal risk of malignant cell dissemination (In case of a false negative diagnosis) and the cytological instead of a histopathological examination. With this in mind, it is important to base management decisions on the sonographic features of the lesions. In addition, cyst aspiration can also be considered in large symptomatic cysts with a high risk of malignancy, but where curative treatment with surgical or chemotherapeutical intervention cannot be considered due to poor general condition of the patient. Especially in the absence of large volume ascites or peritoneal carcinomatosis, but with significant symptoms due to lesion size, cyst aspiration may give short term symptom alleviation. Given the risk of cancer cell dissemination, this intervention is always discussed in a multidisciplinary team discussion, to balance risk and benefits for patients with no other treatment options, Transvaginal needle aspiration is also being used in pelvic abscesses. The study of K. Gjelland et al. found that transvaginal aspiration combined with antibiotic treatment of pelvic abscesses is equally effective as surgically removing them. They state that this should be first-line treatment for abscesses, as it is minimally invasive, leading to better patient tolerance and avoiding the risks associated with anesthesia and surgery. Saline irrigation of the abscess cavity can be performed, making the process of pus aspiration easier when the consistency is too viscous. The literature still lacks studies about the symptom relief in patients receiving treatment for pelvic cystic lesions. Given that this is an important outcome parameter in determining the feasibility of performing procedures, more research in this area is needed. The main aim of this prospective study is to evaluate the patient's symptom relief and cyst recurrence rate after ultrasound-guided transvaginal aspiration of pelvic cystic lesions or abscess drainage. Secondly, the safety and the patient's overall experience during as well as immediately after the procedure will be assessed.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating ultrasound-guided transvaginal aspiration — a minimally invasive procedure to drain fluid-filled cysts and abscesses in the pelvis — as a way to relieve pain and manage pelvic conditions without major surgery. **You may be eligible if...** - You are a woman 18 or older - You have a pelvic cyst, ovarian cyst, pelvic inclusion cyst, or pelvic abscess that is causing symptoms - The cyst is safely accessible by ultrasound-guided transvaginal needle - You are having the procedure either to relieve pain from a benign cyst or as a palliative measure for a non-curable condition **You may NOT be eligible if...** - You are under 18 - You have severe vaginal narrowing (severe atrophy, vaginismus, or have never been sexually active) - Your lesion is purely solid (not fluid-filled) - You have poor overall health that makes the procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTUltrasound-guided transvaginal aspiration of cystic pelvic lesions.

Ultrasound-guided transvaginal aspiration is a minimally invasive procedure used to drain cystic pelvic lesions, such as adnexal cysts or pelvic abscesses. A thin needle is inserted through the vaginal wall under ultrasound guidance to aspirate fluid from the cyst, reducing its size.


Locations(1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

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NCT06988280


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