Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Lesion criteria applicable for therapeutic intervention

Safe accessibility of the lesion (within reach of aspiration needle; visible on ultrasound; transvaginal access; no interposition of bowel or blood vessels)

Lesion types included: cystic lesions (adnexal cysts), pelvic inclusion cysts (pseudocysts), pelvic abscesses

Indications

Disqualifiers

Patients <18 years

Poor performance status contra-indicating the procedure

Vaginal stenosis (severe atrophy - virgo - vaginismus)

Purely solid lesions

Trial population

All patients elligible based on the above mentioned criteria in University Hospitals Leuven.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ultrasound-guided transvaginal aspiration of cystic pelvic lesions.

    Diagnostic test

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients with pelvic cystic lesions (i.e adnexal lesions and abscesses)1 intervention

Trial outcomes

Primary outcomes

1

Pain on verbal rating scale (0-10)

Pain scores indicated by the patient prior to the procedure, during the procedure, one week after and three months after the procedure.

Time frame
• Pain scores indicated by the patient prior to the procedure, during the procedure, one week after and three months after the procedure (based on a verbal rating scale).
2

Recurrence of cyst (binary outcome after 12 months)

Clinical and sonographic follow-up of possible recurrence (up till 12 months). Routine assessment will be done after 3 and 12 months

Time frame
12 months

Secondary outcomes

1

General experience during the procedure (based on verbal rating scale 0-10)

General experience during the procedure based on verbal rating scale, assessed after the procedure by an independent examiner.

Time frame
Right after the procedure to 3 days after.
2

Complications (based on Clavien Dindo classification)

Registration of adverse events, such as Vasovagal reaction, bleeding, infection, excessive pain.

Time frame
Immediately after the procedure to 6 weeks after the procedure.

Other outcomes

1

Cytological and possible microbial analysis of the aspirate.

Assessment of cytological and microbiological analysis of the aspirate if relevant.

Time frame
From the procedure (enrollment) to 2 weeks after the procedure.
2

Difference of inflammatory markers (White blood cell count)

Only applicable in presumed pelvic abscess; Measured at the time of the procedure and 48 hours later, as per our standard ofpractice.

Time frame
From the procedure (enrollment) to 2 weeks after the procedure.
3

Difference in inflammatory markers (C-reactive protein)

Only applicable in presumed pelvic abscess; Measured at the time of the procedure and 48 hours later, as per our standard ofpractice.

Time frame
From the procedure (enrollment) to 2 weeks after the procedure.

Sponsors and contacts

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