Percutaneous Radiofrequency Ablation of Parietal Endometriosis (PRFA) (PRFA)
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- STATUS
- Recruiting
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- End date
- Aug 27, 2023
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- participants needed
- 10
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- sponsor
- Hospices Civils de Lyon
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.
Details
| Condition | Endometriosis |
|---|---|
| Treatment | Percutaneous radiofrequency ablation of parietal endometriosis |
| Clinical Study Identifier | NCT04333017 |
| Sponsor | Hospices Civils de Lyon |
| Last Modified on | 26 July 2022 |
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