Efficacy of Cryoablation of Abdominal Wall Endometriosis: a Phase II Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention
干预措施: Cryoablation (Procedure)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- The evolution of pain (1)(baseline)
- 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 (2)(hour 0)
- The evolution of pain (4)(7 days post-intervention)
- The evolution of pain (3)(6 hours post-intervention)
- The evolution of pain (5)(1 month post-intervention)
- The evolution of pain (6)(3 months post-intervention)
- The evolution of pain (7)(6 months post-intervention)
- The evolution of quality of life(baseline, 3 and 6 months post-intervention)
- The success rate of the technique of cryoablation at 6 months(6 months)