Back to resultsEfficacy of Cryoablation of Abdominal Wall Endometriosis (CRYOENDOMET)
Primary Purpose
Nodule, Endometriosis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cryoablation
Sponsored by
About this trial
This is an interventional treatment trial for Nodule focused on measuring Nodules of endometriosis, Cryoablation
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.
Sites / Locations
- Radiology DepartmentRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Outcomes
Primary Outcome Measures
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.
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
Complications rate at 6 months of cryoablation
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.
The rate of full hospitalization after cryoablation when an outpatient basis was planned
Proportion of hospitalisation in woman with outpatient stay initialy planned.
The length of hospitalization (number of days) when a full hospitalization was planned
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.
The evolution of pain (1)
The evolution of the pain assessed at inclusion (D-90-D-3 = inclusion) by a Numerical scale.
The evolution of pain (2)
The evolution of the pain assessed immediately before (H0) cryoablation by a Numerical scale.
The evolution of pain (3)
The evolution of the pain assessed after cryoablation (H6) by a Numerical scale.
The evolution of pain (4)
The evolution of the pain assessed at D7 by a Numerical scale.
The evolution of pain (5)
The evolution of the pain assessed at 1 month by a Numerical scale.
The evolution of pain (6)
The evolution of the pain assessed at 3 months by a Numerical scale.
The evolution of pain (7)
The evolution of the pain assessed at 6 months by a Numerical scale.
The evolution of quality of life
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.
The success rate of the technique of cryoablation at 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.
Full Information
NCT ID
NCT03627676
First Posted
May 29, 2018
Last Updated
March 12, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03627676
Brief Title
Efficacy of Cryoablation of Abdominal Wall Endometriosis
Acronym
CRYOENDOMET
Official Title
Efficacy of Cryoablation of Abdominal Wall Endometriosis: a Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nodule, Endometriosis
Keywords
Nodules of endometriosis, Cryoablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Cryoablation
Intervention Description
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 Measure Information:
Title
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.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Complications rate at 6 months of cryoablation
Description
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.
Time Frame
6 months
Title
The rate of full hospitalization after cryoablation when an outpatient basis was planned
Description
Proportion of hospitalisation in woman with outpatient stay initialy planned.
Time Frame
6 months
Title
The length of hospitalization (number of days) when a full hospitalization was planned
Description
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.
Time Frame
6 months
Title
The evolution of pain (1)
Description
The evolution of the pain assessed at inclusion (D-90-D-3 = inclusion) by a Numerical scale.
Time Frame
baseline
Title
The evolution of pain (2)
Description
The evolution of the pain assessed immediately before (H0) cryoablation by a Numerical scale.
Time Frame
hour 0
Title
The evolution of pain (3)
Description
The evolution of the pain assessed after cryoablation (H6) by a Numerical scale.
Time Frame
6 hours post-intervention
Title
The evolution of pain (4)
Description
The evolution of the pain assessed at D7 by a Numerical scale.
Time Frame
7 days post-intervention
Title
The evolution of pain (5)
Description
The evolution of the pain assessed at 1 month by a Numerical scale.
Time Frame
1 month post-intervention
Title
The evolution of pain (6)
Description
The evolution of the pain assessed at 3 months by a Numerical scale.
Time Frame
3 months post-intervention
Title
The evolution of pain (7)
Description
The evolution of the pain assessed at 6 months by a Numerical scale.
Time Frame
6 months post-intervention
Title
The evolution of quality of life
Description
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.
Time Frame
baseline, 3 and 6 months post-intervention
Title
The success rate of the technique of cryoablation at 6 months
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Cornelis, Professor
Phone
+33 1 56 01 68 87
Email
francois.cornelis@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Cornelis, Professor
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiology Department
City
Paris
ZIP/Postal Code
75970
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Cornelis, Professor
Phone
+33 1 56 01 68 87
Email
francois.cornelis@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Cryoablation of Abdominal Wall Endometriosis
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