Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma

NCT06274086 | Completed

• 1 other identifier: S2022-2027-0001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Sclerotherapy; Endometrioma

Outcome Measures

Primary Outcomes (1)

• Recurrence

  Recurrence of endometrioma was assessed

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

Study Arms (1)

Two-session catheter-directed sclerotherapy

EXPERIMENTAL

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

Interventions

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).

Two-session catheter-directed sclerotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of gynecologic malignancy
• Active inflammation or infection
• Abnormal coagulation profile
• Loss to follow-up

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ji Hoon Shin, MD, PhD

  Asan Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 23, 2024
• Study Start: June 1, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

KR (1)