Actively Recruiting

Age: 18Years +
FEMALE
NCT06988280

Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-05-23

100

Participants Needed

1

Research Sites

194 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Lesions must be safely accessible for treatment via ultrasound-guided transvaginal aspiration with no bowel or blood vessels in the way
  • Lesion types include cystic pelvic lesions such as adnexal cysts, pelvic inclusion cysts (pseudocysts), and pelvic abscesses
  • Indicated for pain relief in symptomatic benign cystic lesions
  • Symptomatic treatment for probably malignant lesions only when curative treatment is not possible
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Poor health status that prevents undergoing the procedure
  • Vaginal stenosis, including severe atrophy, virginity, or vaginismus
  • Cystic lesions that are purely solid
  • Cystic lesions suspected to be malignant when curative treatment is possible due to risk of tumor spread
  • Asymptomatic physiological cysts; if uncertain, reassessment after 3-6 months is required

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

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Research Team

S

Stefan Timmerman, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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