NCT06274086

Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma

Safety and Clinical Outcomes of Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sclerotherapy
• Endometrioma

Interventions

Type	Name	Description
PROCEDURE	Two-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).

Timeline

• Start date: 2020-06-01
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2024-02-23
• Last updated: 2024-02-23

Locations

1 site across 1 country: South Korea