Efficacy of Cryoablation of Abdominal Wall Endometriosis

NCT03627676 | Unknown

• 2 other identifiers: P160802J2017-A02409-44
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Nodule; Endometriosis

Keywords

Nodules of endometriosis; Cryoablation

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (12)

• Complications rate at 6 months of cryoablation

  6 months

• The rate of full hospitalization after cryoablation when an outpatient basis was planned

  6 months

• The length of hospitalization (number of days) when a full hospitalization was planned

  6 months

• The evolution of pain (1)

  baseline

• The evolution of pain (2)

  hour 0

Study Arms (1)

Intervention

EXPERIMENTAL

Procedure: Cryoablation

Interventions

Cryoablation PROCEDURE

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• 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.

You may not qualify if:

• Pregnant woman,
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Radiology Department

Paris, 75970, France

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• François Cornelis, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François Cornelis, Professor

CONTACT

+33 1 56 01 68 87; francois.cornelis@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: August 13, 2018
• Study Start: February 8, 2018
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2020
• Last Updated: March 14, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)