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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333017
Recruitment Status : Not yet recruiting
First Posted : April 3, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Endometriosis Device: Percutaneous radiofrequency ablation of parietal endometriosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Radiofrequency Ablation of Parietal Endometriosis : a Pilot Study (PRFA)
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: treated patient
Percutaneous radiofrequency ablation of parietal endometriosis
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 needle if < 50mm, 2 to 3 needles if > 50mm). 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.




Primary Outcome Measures :
  1. Feasibility of PRFA. Evaluation by composite criteria with the need to validate all the criteria for the procedure to be considered "feasible". [ Time Frame: The day of the treatment (Day 0) - no earlier than 7 days after the 1st visit ]

    The treatment is considered "feasible" if it meets all of the following criteria:

    • Visualization of the lesion intraoperatively by percutaneous ultrasound (yes/no),
    • Visibility of the posterior aponeurosis/peritoneum interface behind the lesion (yes/no),
    • Placement of one or more radiofrequency (RF) needles within the target lesion (yes/no),
    • Procedure for firing without anomaly (yes/no) :

      • Performing one or more treatment zones until a drop in effective power is obtained, automatically interrupting needle activity and demonstrating the effectiveness of the treatment.
      • complete covering of the nodule by the CO bubbles released by the procedure.


Secondary Outcome Measures :
  1. Security and tolerance of PRFA [ Time Frame: From the 1st visit (no later than 7 days before treatment (Day -7)) until the end of the study (Month 6) ]
    Number, type and severity of adverse events related to radiofrequency treatment. Pain during treatment.

  2. radiological effectiveness measured by ultrasonography with Sonovue (composite criteria) [ Time Frame: 1 month post therapeutic (Month 1) ]
    • Diameters (largest, orthogonal to the largest diameter and anteroposterior diameter [in cm]) and volume (in cm3) of the lesions,
    • Echogenicity to muscle (hypo- / iso- / hyper-echoic)
    • Presence of a posterior shadow cone (yes/no)
    • Sonovue characteristics (no, moderate or frank enhancement)
    • US Doppler characteristics (no, slight or marked vascularization)
    • Characteristics in Shearwave elastography (in kPa)
    • Evaluation by the radiologist of the percentage of nodule volume presenting a change in appearance on ultrasound (0% / < 50% / > 50% / 100%)

  3. radiological effectiveness measured by ultrasonography with Sonovue (composite criteria) [ Time Frame: 3 month post therapeutic (Month 3) ]
    • Diameters (largest, orthogonal to the largest diameter and anteroposterior diameter [in cm]) and volume (in cm3) of the lesions,
    • Echogenicity to muscle (hypo- / iso- / hyper-echoic)
    • Presence of a posterior shadow cone (yes/no)
    • Sonovue characteristics (no, moderate or frank enhancement)
    • US Doppler characteristics (no, slight or marked vascularization)
    • Characteristics in Shearwave elastography (in kPa)
    • Evaluation by the radiologist of the percentage of nodule volume presenting a change in appearance on ultrasound (0% / < 50% / > 50% / 100%)

  4. radiological effectiveness measured by ultrasonography with Sonovue (composite criteria) [ Time Frame: 6 month post therapeutic (Month 6) ]

    volume (in cm3) of the lesions,

    • Echogenicity to muscle (hypo- / iso- / hyper-echoic)
    • Presence of a posterior shadow cone (yes/no)
    • Sonovue characteristics (no, moderate or frank enhancement)
    • US Doppler characteristics (no, slight or marked vascularization)
    • Characteristics in Shearwave elastography (in kPa)
    • Evaluation by the radiologist of the percentage of nodule volume presenting a change in appearance on ultrasound (0% / < 50% / > 50% / 100%)

  5. radiological effectiveness measured by MRI with Gadolinium (composite criteria) [ Time Frame: 6 month post therapeutic (Month 6) ]
    • Diameters (largest, orthogonal to the largest diameter and anteroposterior diameter [in cm]) and volume (in cm3) of the lesions
    • signal in T2 sequence with respect to the muscle (hypo- / iso- / hyper-signal) ;
    • presence of T1 hypersignal (yes/no);
    • minimum and maximum ADC (Apparent Diffusion Coefficent) value (in mm²/s);
    • lesional enhancement in the center (yes/no);
    • Peri-lesional enhancement (yes/no);

  6. clinical efficiency (composite criteria) [ Time Frame: 1 month post therapeutic (Month 1) ]
    Assessment of pain related to the lesion: maximum EVA during menstruation and maximum EVA outside of menstruation

  7. clinical efficiency measured by SF36 [ Time Frame: 1 month post therapeutic (Month 1) ]
    Quality of life of patients measured by validated questionnaire in endometriosis: SF36 (Short Form (36) Health Survey)

  8. clinical efficiency measured by EHP-5 [ Time Frame: 1 month post therapeutic (Month 1) ]
    Quality of life of patients measured by validated questionnaire in endometriosis: EHP-5 (Endometriosis Health Profile)

  9. clinical efficiency (composite criteria) [ Time Frame: 3 month post therapeutic (Month 3) ]
    Assessment of pain related to the lesion: maximum EVA during menstruation and maximum EVA (Echelle Visuelle Analogique) outside of menstruation

  10. clinical efficiency measured by SF36 [ Time Frame: 3 month post therapeutic (Month 3) ]
    Quality of life of patients measured by validated questionnaire in endometriosis: SF36

  11. clinical efficiency measured by EHP-5 [ Time Frame: 3 month post therapeutic (Month 3) ]
    Quality of life of patients measured by validated questionnaire in endometriosis: EHP-5

  12. clinical efficiency (composite criteria) [ Time Frame: 6 month post therapeutic (Month 6) ]
    Assessment of pain related to the lesion: maximum EVA during menstruation and maximum EVA outside of menstruation

  13. clinical efficiency measured by SF36 [ Time Frame: 6 month post therapeutic (Month 6) ]
    Quality of life of patients measured by validated questionnaire in endometriosis: SF36

  14. clinical efficiency measured by EHP-5 [ Time Frame: 6 month post therapeutic (Month 6) ]
    Quality of life of patients measured by validated questionnaire in endometriosis: EHP-5

  15. population characteristics (composite criteria) [ Time Frame: At the 1st visit: up to 7 days before treatment (Day -7) ]
    age, gestational age, parity, history of caesarean section, history of gynaecological surgery excluding endometriosis, history of endometriosis surgery, age of diagnosis of endometriosis, age of diagnosis of parietal endometriosis.

  16. Feature of PRFA: power of the shot [ Time Frame: The day of the treatment (Day 0) no earlier than 7 days after the 1st visit ]
    Description of the procedure: power (Watt) of the shot

  17. Feature of PRFA: duration of the shot [ Time Frame: The day of the treatment (Day 0) no earlier than 7 days after the 1st visit ]
    Description of the procedure: duration (min) of the shot.

  18. Feature of PRFA: total duration (min) of the procedure [ Time Frame: The day of the treatment (Day 0) - no earlier than 7 days after the 1st visit ]
    Description of the procedure: total duration (min) of the procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient over 18 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
  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333017


Contacts
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Contact: Charles-André PHILIP +33 4 72 07 19 36 charles-andre.philip@chu-lyon.fr
Contact: Audrey HAQUIN +33 4 26 10 91 86 audrey.haquin@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, France, 69002
Contact: Charles-André PHILIP    + 33 4 72 07 19 36    charles-andre.philip@chu-lyon.fr   
Principal Investigator: Charles-André PHILIP         
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04333017    
Other Study ID Numbers: 69HCL19_0826
2020-A00320-39 ( Other Identifier: ANSM )
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Parietal endometriosis
Abdominal Wall endometriosis
Percutaneous radiofrequency ablation
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female