Efficacy of Cryoablation of Abdominal Wall Endometriosis (CRYOENDOMET)

Efficacy of Cryoablation of Abdominal Wall Endometriosis: a Phase II Trial

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.

Study Overview

• Status: Unknown
• Conditions: Endometriosis; Nodule
• Intervention / Treatment: Procedure: Cryoablation

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).

• Study Type: Interventional
• Enrollment (Anticipated): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75970
    • Recruiting
    • Radiology Department
    • Contact: François Cornelis, Professor; Phone Number: +33 1 56 01 68 87; Email: francois.cornelis@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
The rate of full hospitalization after cryoablation when an outpatient basis was planned	Proportion of hospitalisation in woman with outpatient stay initialy planned.	6 months
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.	6 months
The evolution of pain (1)	The evolution of the pain assessed at inclusion (D-90-D-3 = inclusion) by a Numerical scale.	baseline
The evolution of pain (2)	The evolution of the pain assessed immediately before (H0) cryoablation by a Numerical scale.	hour 0
The evolution of pain (3)	The evolution of the pain assessed after cryoablation (H6) by a Numerical scale.	6 hours post-intervention
The evolution of pain (4)	The evolution of the pain assessed at D7 by a Numerical scale.	7 days post-intervention
The evolution of pain (5)	The evolution of the pain assessed at 1 month by a Numerical scale.	1 month post-intervention
The evolution of pain (6)	The evolution of the pain assessed at 3 months by a Numerical scale.	3 months post-intervention
The evolution of pain (7)	The evolution of the pain assessed at 6 months by a Numerical scale.	6 months post-intervention
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.	baseline, 3 and 6 months post-intervention
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.	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: François Cornelis, Professor, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Cryoablation; Nodules of endometriosis
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: P160802J; 2017-A02409-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No