Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2023-03-31

Brief Summary

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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

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Detailed Description

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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

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Sclerotherapy Endometrioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Two-session catheter-directed sclerotherapy

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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