Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma

Asan Medical Center

Status: Completed

Conditions: Sclerotherapy; Endometrioma

Treatments: Procedure: Two-session catheter-directed sclerotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06274086

S2022-2027-0001

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Two-session catheter-directed sclerotherapy

Experimental group

Description:

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

Treatment:

Procedure: Two-session catheter-directed sclerotherapy