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Efficacy of Cryoablation of Abdominal Wall Endometriosis (CRYOENDOMET)

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ClinicalTrials.gov Identifier: NCT03627676
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Nodule Endometriosis Procedure: Cryoablation Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Cryoablation of Abdominal Wall Endometriosis: a Phase II Trial
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: Intervention Procedure: Cryoablation
Two percutaneous cryoprobes would be used for all patients. The 17-Gauge cryoprobes is introduced into the masses under US guidance. Mean distance to the skin has to be 5mm at least. Although US guidance is used, a non-enhanced CT scan may be used to assess the position of the cryoprobes before ablation, and to obtain a baseline examination in order to avoid thermal injuries to adjacent tissues such as the bowel during the ice growth. No ice extension to the skin has to be observed during cycles assessed by real-time US monitoring. Each cryoablation procedure involves 3 successive cycles: 10 minutes freeze with Argon gas, followed by 9 minutes passive and 1 minute active thawing with Helium gas, followed by a second 7 minutes freeze. The ice covered the entire targeted lesion on the short axes is visualize by US or CT-scan performed at the end of the three cycles or after repositioning. At the end of the cryoablation procedures, the probes are removed through active thawing.




Primary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]

    The post-therapeutic pain is quantified by Numerical Scale (NS) at 6 months of cryoablation.

    Clinical success is defined as a complete response (NS= 0) or a reduction of at least 50% in the NS score at baseline.



Secondary Outcome Measures :
  1. Complications rate at 6 months of cryoablation [ Time Frame: 6 months ]
    The occurrence of all complications of cryoablation between the intervention and the end of follow-up, according to the classification of the NCI-CTCAE toxicity scale, will be considered.

  2. The rate of full hospitalization after cryoablation when an outpatient basis was planned [ Time Frame: 6 months ]
    Proportion of hospitalisation in woman with outpatient stay initialy planned.

  3. The length of hospitalization (number of days) when a full hospitalization was planned [ Time Frame: 6 months ]
    Total duration of hospitalization according to the type of initial stay (outpatient or hospitalization) planned, defined as the time (number of days) from the date of entry and the date of departure of the initial intervention + delays (in days) between entry date for a new intervention and date of exit within the limit of 6 Months of follow-up.

  4. The evolution of pain (1) [ Time Frame: baseline ]
    The evolution of the pain assessed at inclusion (D-90-D-3 = inclusion) by a Numerical scale.

  5. The evolution of pain (2) [ Time Frame: hour 0 ]
    The evolution of the pain assessed immediately before (H0) cryoablation by a Numerical scale.

  6. The evolution of pain (3) [ Time Frame: 6 hours post-intervention ]
    The evolution of the pain assessed after cryoablation (H6) by a Numerical scale.

  7. The evolution of pain (4) [ Time Frame: 7 days post-intervention ]
    The evolution of the pain assessed at D7 by a Numerical scale.

  8. The evolution of pain (5) [ Time Frame: 1 month post-intervention ]
    The evolution of the pain assessed at 1 month by a Numerical scale.

  9. The evolution of pain (6) [ Time Frame: 3 months post-intervention ]
    The evolution of the pain assessed at 3 months by a Numerical scale.

  10. The evolution of pain (7) [ Time Frame: 6 months post-intervention ]
    The evolution of the pain assessed at 6 months by a Numerical scale.

  11. The evolution of quality of life [ Time Frame: baseline, 3 and 6 months post-intervention ]
    The evolution of the quality of life by the EHP-5 self-questionnaire. The quality of life is assessed at inclusion and at 3 and 6 months of cryoablation.

  12. The success rate of the technique of cryoablation at 6 months [ Time Frame: 6 months ]
    The technical success at 6 months is defined by a reduction in volume of endometriosis nodule of at least 2/3 of the initial volume on MRI (complete or partial response on MRI according to the RECIST criteria) at 6 months of treatment. Success rate will be assessed at the level of the treated nodule.



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 ≥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.

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): NCT03627676


Contacts
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Contact: François Cornelis, Professor +33 1 56 01 68 87 francois.cornelis@aphp.fr

Locations
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France
Radiology Department Recruiting
Paris, France, 75970
Contact: François Cornelis, Professor    +33 1 56 01 68 87    francois.cornelis@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: François Cornelis, Professor Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03627676    
Other Study ID Numbers: P160802J
2017-A02409-44 ( Other Identifier: ANSM )
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Assistance Publique - Hôpitaux de Paris:
Nodules of endometriosis
Cryoablation
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female