Clinical trial NCT03627676: Efficacy of Cryoablation of Abdominal Wall Endometriosis
Official title: Efficacy of Cryoablation of Abdominal Wall Endometriosis: a Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nodule
Endometriosis
Keywords: Nodules of endometriosis
Cryoablation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate for the first time prospectively the efficacy on the symptoms and the tolerance of percutaneous cryoablation performed under radiological guidance of endometriosis of the abdominal wall in alternative to surgery after validation in multidisciplinary meeting.

Detailed description: Design of the study :

Non-comparative, non-randomized monocentric phase II trial designed as a two-staged Simon minimax plan.

Inclusions will be suspended at the end of the first stage. Statistical stopping rules are detailed in the justification of the number of patients required.

Inclusion: Patients will be included after validation in multidisciplinary consultation by the interventional radiologist in charge of the patient.

Follow-up: Only the cryoablation procedure is performed as an alternative to surgery, the usual follow-up of these patients will be maintained (1 consultation / 3 months, 1 MRI every 6 months). Additional consultations on D7 and M1 will be conducted by phone (symptoms and pain history only).

Device(s) under investigation The Endocare® Cryocare® Systems consist of a compact, easy-to-operate console and associated accessories that include Endocare® cryoprobes to deliver cold temperatures to the therapeutic tissue and Endocare® TempProbe® devices to monitor temperatures in the surrounding tissue. The Cryocare® Systems are intended for use in open, minimally invasive procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, proctology, pulmonary surgery and thoracic surgery.

The systems are designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

CE Mark; Classe IIa

Expected benefits for the participants and for society This study has a direct individual benefit because of the proposed curative treatment by cryoablation as an alternative to other therapeutic modalities. For the society, the minimally invasive cryoablation may reduce the hospitalization stay and the complication's rate compare to the reference standard (surgery).

Eligibility criteria: Inclusion Criteria:

* Patient ≥18 years,
* Initial radiological diagnosis of endometriosis of the abdominal wall, radiologically proven by MRI (or Doppler-ultrasound or CT-scan) with or without contrast injection,
* Symptomatic nodule (pain),
* Patient in at least one of the following situations:

  * Failure of previous treatments: recurrence of symptoms (pain) after medical therapies following the Haute Autorité de Santé (HAS) recommendations and / or prior surgery,
  * Or first-line or second-line medical therapies following the HAS recommendations considered as potentially non effective locally in multidisciplinary consultation meeting, or contraindicated or refused by patient,
  * Or surgery considered as potentially non effective locally or as a potential cause of adverse effects and morbidity because too devastating, in multidisciplinary consultation meeting,
* Cryoablation technically feasible after discussion in multidisciplinary consultation meeting:

  * localization at a distance of 5 mm from the skin (risk of skin lesion if the ice ball is at less than 5 mm from the skin) and from major nervous structures (risk of sideration),
  * 3 nodules maximum
  * nodule size up to 5 cm (\<5 cm) in the largest diameter
* Absence of contraindications to general anesthesia if applicable,
* Effective contraception during participation in the study.
* Informed consent signed,
* Patient affiliated to a social security.

Exclusion Criteria:

* Pregnant woman,
* Uncontrolled coagulation disorders (TP \<50%, TCA\> 1.5x control) or anticoagulant therapy (blood sample prescribed at the inclusion and results verified at D0),
* Abnormalities of the hemogram: platelets \<90000/mm3 (blood sample prescribed at the inclusion and results verified at D0),
* Documented infectious disease,
* Patient included in another interventional study,
* Impossibility to submit to the medical follow-up for geographical, social or psychological reasons,
* Patients deprived of liberty or subject to a legal protection measure or unable to express their consent.

Primary outcomes:
measure: To evaluate the clinical efficacy at 6 months of cryoablation on the pain initially presented by the patients, pain being the principal reason of consultation.
timeFrame: 6 months
Secondary outcomes:
measure: Complications rate at 6 months of cryoablation
timeFrame: 6 months
measure: The rate of full hospitalization after cryoablation when an outpatient basis was planned
timeFrame: 6 months
measure: The length of hospitalization (number of days) when a full hospitalization was planned
timeFrame: 6 months
measure: The evolution of pain (1)
timeFrame: baseline
measure: The evolution of pain (2)
timeFrame: hour 0
measure: The evolution of pain (3)
timeFrame: 6 hours post-intervention
measure: The evolution of pain (4)
timeFrame: 7 days post-intervention
measure: The evolution of pain (5)
timeFrame: 1 month post-intervention
measure: The evolution of pain (6)
timeFrame: 3 months post-intervention
measure: The evolution of pain (7)
timeFrame: 6 months post-intervention
measure: The evolution of quality of life
timeFrame: baseline, 3 and 6 months post-intervention
measure: The success rate of the technique of cryoablation at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Radiology Department
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: François Cornelis, Professor
role: PRINCIPAL_INVESTIGATOR
References: