Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma

Not Applicable

Completed

• Conditions: Endometrioma; Sclerotherapy
• Interventions: Procedure: Two-session catheter-directed sclerotherapy

• Registration Number: NCT06274086
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2024-02
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Two-session catheter-directed sclerotherapy	Two-session catheter-directed sclerotherapy	Each patient received two sessions of catheter-directed sclerotherapy for endometrioma 1 day apart with the catheter left in situ overnight.

Primary Outcome Measures

Name	Time	Method
Recurrence	Recurrence was assessed at 1, 3, and 6 months after the procedure.	Recurrence of endometrioma was assessed

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of