Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma

Endometrioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06274086
• Other study ID #: S2022-2027-0001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: February 2024
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis
• Sclerotherapy

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Recurrence of endometrioma was assessed	Recurrence was assessed at 1, 3, and 6 months after the procedure.