Endometrioma, Sclerotherapy
Conditions
Brief summary
The goal of this clinical trial is to evaluate the safety and clinical outcomes of two-session catheter-directed sclerotherapy (CDS) with 96% ethanol in patients with endometrioma. The main question it aims to answer is: • Is two-session CDS with 96% ethanol safe and effective for treating endometrioma? Participants will: * Receive the first session CDS for endometrioma * Carry the catheter overnight and be monitored in the patient ward * Receive the second session CDS the next day
Detailed description
Catheter-directed sclerotherapy has been reported as an effective treatment for endometrioma. However, whether the sclerosing agent should be retained inside the endometrioma was controversial. To increase the contact between the sclerosing agent and the endometrioma wall, two-session catheter-directed sclerotherapy using 96% ethanol was attempted, and safety and clinical outcomes were assessed in patients with endometrioma.
Interventions
PROCEDURETwo-session catheter-directed sclerotherapy
After receiving the first session of catheter-directed sclerotherapy, each patient carries the catheter overnight and is closely monitored in the patient ward. Then, the patient receives the second session the next day. The catheter is removed after the second session. The procedure was performed under intravenous sedoanalgesia using a combination of 25 mg pethidine hydrochloride and 50 mg fentanyl. Devices used during the procedure included: * An 18-gauge, 20-cm Chiba biopsy needle (Cook, Bloomington, IN, USA); * A 0.035-inch hydrophilic guidewire (Terumo, Tokyo, Japan); * A 7- or 8.5-F pigtail catheter (Dawson-Mueller Drainage Catheter; Cook).
Sponsors
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged ≥ 18 years * Symptom manifestation as endometriosis (i.e., dysmenorrhea, dyspareunia, and lower abdominal or pelvic pain) * Endometrioma ≥ 3 cm confirmed on ultrasound * No evidence of solid lesions on ultrasound * No suspected extraovarian endometriosis
Exclusion criteria
* History of gynecologic malignancy * Active inflammation or infection * Abnormal coagulation profile * Loss to follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence | Recurrence was assessed at 1, 3, and 6 months after the procedure. | Recurrence of endometrioma was assessed |
Countries
South Korea
Outcome results
None listed