Percutaneous Radiofrequency Ablation of Parietal Endometriosis (PRFA)

NCT ID: NCT04333017

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-12
• Study Completion Date: 2023-01-31

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.

Conditions

Endometriosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treated patient

Percutaneous radiofrequency ablation of parietal endometriosis

Group Type: EXPERIMENTAL

Percutaneous radiofrequency ablation of parietal endometriosis

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, , France

Countries

France

References

Haquin A, Delacroix C, Rode A, Taconet D, Maissiat E, Boussel L, Dubernard G, Philip CA. Feasibility of Percutaneous Radiofrequency Ablation for Abdominal Wall Endometriosis: A Prospective Pilot Study. J Minim Invasive Gynecol. 2025 Mar;32(3):288-296. doi: 10.1016/j.jmig.2024.10.022. Epub 2024 Oct 26.

Reference Type: RESULT

PMID: 39490892 (View on PubMed)

Other Identifiers

2020-A00320-39

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL19_0826

Identifier Type: -

Identifier Source: org_study_id