Percutaneous Radiofrequency Ablation of Parietal Endometriosis (PRFA) (PRFA)

  • STATUS
    Recruiting
  • End date
    Aug 27, 2023
  • participants needed
    10
  • sponsor
    Hospices Civils de Lyon
Updated on 26 July 2022
cancer
local anesthetic
analgesic
endometriosis
fibroids
uterine fibroids
adenomyosis

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 IdentifierNCT04333017
SponsorHospices Civils de Lyon
Last Modified on26 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient over 25 years of age
Presenting between 1 and 3 lesions of parietal endometriosis, all accessible to radiofrequency treatment, with a major axis less than 10cm
Symptomatic (chronic and/or catamenial pain)
Histological diagnosis of endometriosis
In failure of medical treatment
Nodule visible on ultrasound
Affiliated with or beneficiary of a social security or similar scheme
Having signed an informed consent for participation in the study

Exclusion Criteria

Presence of a parietal endometriosis lesion with superficial skin involvement (dermis)
Presence of other symptomatic extra-parietal endometriosis lesions for which surgical treatment is planned
Uncontrolled diabetes, i.e. HbA1c >7% despite well-treated and well-controlled treatment
Contraindication to the use of radiofrequency: implanted electronic device, such as a pacemaker or self-synchronizing defibrillator; weakened immune system; coagulation disorder
Contraindication to the use of Sonovue
Contraindication to the use of gadolinium
Severe renal failure (glomerular filtration rate less than 30 ml / min / 1.73m²)
Pregnant patient or with a desire to become pregnant within 6 months after treatment
Patient who is not fluent in the English language
Patient over the age of majority protected by law, under curatorship or guardianship
Person deprived of liberty by a judicial or administrative decision, person subject to psychiatric care and people admitted to a health or social establishment for purposes other than that of research
Patient participating in other interventional research that may interfere with the present research (at the discretion of the investigator)
Patient who has participated in other research that includes an ongoing opt out period
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