Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma

February 15, 2024 updated by: Ji Hoon Shin, Asan Medical Center

Safety and Clinical Outcomes of 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: Recurrence was assessed at 1, 3, and 6 months after the procedure.
Recurrence of endometrioma was assessed
Recurrence was assessed at 1, 3, and 6 months after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Study Chair: Ji Hoon Shin, MD, PhD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2022-2027-0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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