Clinical trial NCT04333017: Percutaneous Radiofrequency Ablation of Parietal Endometriosis (PRFA)
Official title: Percutaneous Radiofrequency Ablation of Parietal Endometriosis : a Pilot Study (PRFA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: Parietal endometriosis
Abdominal Wall endometriosis
Percutaneous radiofrequency ablation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 11
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of PRFA. Evaluation by composite criteria with the need to validate all the criteria for the procedure to be considered "feasible".
timeFrame: The day of the treatment (Day 0) - no earlier than 7 days after the 1st visit
Secondary outcomes:
measure: Security and tolerance of PRFA
timeFrame: From the 1st visit (no later than 7 days before treatment (Day -7)) until the end of the study (Month 6)
measure: radiological effectiveness measured by ultrasonography with Sonovue (composite criteria)
timeFrame: 1 month post therapeutic (Month 1)
measure: radiological effectiveness measured by ultrasonography with Sonovue (composite criteria)
timeFrame: 3 month post therapeutic (Month 3)
measure: radiological effectiveness measured by ultrasonography with Sonovue (composite criteria)
timeFrame: 6 month post therapeutic (Month 6)
measure: radiological effectiveness measured by MRI with Gadolinium (composite criteria)
timeFrame: 6 month post therapeutic (Month 6)
measure: clinical efficiency (composite criteria)
timeFrame: 1 month post therapeutic (Month 1)
measure: clinical efficiency measured by SF36
timeFrame: 1 month post therapeutic (Month 1)
measure: clinical efficiency measured by EHP-5
timeFrame: 1 month post therapeutic (Month 1)
measure: clinical efficiency (composite criteria)
timeFrame: 3 month post therapeutic (Month 3)
measure: clinical efficiency measured by SF36
timeFrame: 3 month post therapeutic (Month 3)
measure: clinical efficiency measured by EHP-5
timeFrame: 3 month post therapeutic (Month 3)
measure: clinical efficiency (composite criteria)
timeFrame: 6 month post therapeutic (Month 6)
measure: clinical efficiency measured by SF36
timeFrame: 6 month post therapeutic (Month 6)
measure: clinical efficiency measured by EHP-5
timeFrame: 6 month post therapeutic (Month 6)
measure: population characteristics (composite criteria)
timeFrame: At the 1st visit: up to 7 days before treatment (Day -7)
measure: Feature of PRFA: power of the shot
timeFrame: The day of the treatment (Day 0) no earlier than 7 days after the 1st visit
measure: Feature of PRFA: duration of the shot
timeFrame: The day of the treatment (Day 0) no earlier than 7 days after the 1st visit
measure: Feature of PRFA: total duration (min) of the procedure
timeFrame: The day of the treatment (Day 0) - no earlier than 7 days after the 1st visit
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse
Study officials:
References: