Percutaneous Radiofrequency Ablation of Parietal Endometriosis (PRFA)

Summary

Parietal endometriosis is the implantation of endometrial tissue in abdominal structures more superficial than the peritoneum. It is a rare form of the disease (incidence estimated between 0.04 and 12% among women operated on for endometriosis depending on the series) but is classically resistant to medical treatment and can be disabling. Surgical resection is currently the reference treatment in the event of failure of hormonal treatment, despite the sometimes significant skin scars and the risk of parietal fragility that may require a cure of venting by parietal prosthesis. The recurrence rate after surgical resection is 4.3%. The use of radiofrequency for therapeutic purposes is nowadays described in multiple applications such as cardiac arrhythmia, neurological and spinal disorders, as well as for the treatment of liver, kidney, prostate, breast, lung or skin cancers. Its use has already been reported in the field of benign gynecology with, in particular, demonstrated efficacy in the treatment of uterine fibroids by laparoscopic, trans-vaginal or percutaneous means. There are also large published series on radiofrequency for the treatment of adenomyosis, by the transvaginal and laparoscopic route.

In the context of parietal endometriosis, this would be a minimally invasive, percutaneous treatment. Ultrasound guidance allowing good targeting of the lesions and the procedure would most often be carried out on an outpatient basis and under local anaesthesia. And in case of failure or partial effectiveness, the reference treatment would remain accessible for these patients.

There is only one published case of the use of radiofrequency in parietal endometriosis (case reports). Despite results that seem encouraging in terms of a rapid and prolonged therapeutic effect on symptoms, no further cases or series have been published since.

Our study aims to investigate the feasibility of percutaneous radiofrequency treatment for parietal endometriosis, with the secondary objective of evaluating the safety, efficacy and risk factors for failure of the technique.

10 patients will be treated. For follow-up all patients will have an ultrasound and MRI before treatment, then an ultrasound at 1 month, 3 months and 6 months post-treatment and a second MRI at 6 months post-treatment. The investigators will also evaluate pain and quality of life with specific questionnaires at each visit.

Conditions

• Endometriosis

Interventions

DEVICE

Percutaneous radiofrequency ablation of parietal endometriosis

Treatment is carried out under local anaesthesia after surgical asepsis, in interventional radiology room. Radiofrequency needles are inserted percutaneously under ultrasound guidance. Number of needles depends on the size of lesion (1 or 2 or 3 needles). In case of proximity between lesion and peritoneum, artificial ascites can be performed. Treatment is carried out in accordance with device's instructions for use (thyroid nodules treatment algorithm), with a gradual increase in power every 5 minutes, without exceeding the maximum authorised power (depending on number and length of needles). State of coagulation is monitored under visual ultrasound control of ablation area (diffusion of Co bubbles), until a decrease in effective power is obtained. Several ablation zones are performed on the same nodule with overlapping of the different impacts. An ice pack is applied to the treated area. An analgesic PO treatment of step 1 and/or 2 is prescribed for 5 days.

Sponsors & Collaborators

• Hospices Civils de Lyon

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

25 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-12

Primary Completion

2022-07-27

Completion

2023-01-31

Countries

• France

Study Locations