Skip to main content
OpenTrials
Completed

NCT Number: NCT06274086

Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sclerotherapy Endometrioma Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Two-session catheter-directed sclerotherapy

Procedure

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).

Primary outcomes

  1. Recurrence

    Time frame: Recurrence was assessed at 1, 3, and 6 months after the procedure.

    Recurrence of endometrioma was assessed

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.