Place of Endoscopic Rectal Ultrasound With Elastosonography and Contrast in Diagnosis and Supported of Deep Pelvic Endometriosis With Bowel Involvement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Relevance of endoscopic elastosonography for description and characterization of digestive endometriosis lesions, using a ratio of elastonography.
研究概览
简要总结
The aim of the study will be to determine the diagnostic and prognostic value of elastosonography and the use of the contrast agent (Sonovue®) in the endoscopic ultrasound exploration of deep pelvic endometriosis.
详细描述
To diagnose deep infiltrating endometriosis, a clinical examination may be performed by a gynecologist to look for typical signs of endometriosis, but in 25% of case there can be absent.
According to that, medical imaging is indispensable in diagnosis of pelvic endometriosis. Trans vaginal ultrasonography, and pelvic MRI are major tools in the hands of specialists, but several studies have shown the importance of endoscopic rectal ultrasound, with a sensitivity close to 90% for de diagnosis of digestive impairment.
In recent years the use of elastography and the injection of microbubbles of sulfur hexafluoride in addition to endoscopic ultrasound has made it possible to improve the diagnostic accuracy of the technique in tumoral pathologies, in particular bilio-pancreatic injuries.
However, no study has yet evaluated the endoscopic rectal ultrasound with elastometry and injection of contrast agent to characterize the digestive lesions of deep pelvic endometriosis.
The endoscopic rectal ultrasound has demonstrated its place in the evaluation of deep pelvic endometriosis disease but its latest complementary techniques of interest have not yet been studied prospectively. The aim of the study will be to determine the diagnostic and prognostic value of elastosonography and the use of the contrast agent (Sonovue®) in the endoscopic ultrasound exploration of deep pelvic endometriosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Woman over 18 years of age
- •Diagnosis of deep pelvic endometriosis (clinical and / or MRI and / or transvaginal ultrasound), defined by penetrating endometriosis lesions in the retroperitoneal space and / or pelvic organ wall at a depth of at least 5 millimeters , with digestive impairment.
- •Presenting symptoms of deep pelvic endometriosis disabling and / or fertility difficulties and requiring an exhaustive iconographic assessment.
- •Belong to a social security scheme.
- •Signature of informed consent.
排除标准
- •Without medical contraindication to the realization of a low digestive endoscopy.
- •Allergy or hypersensitivity to sulfur hexafluoride or one of the components of Sonovue® (contrast agent used in endoscopy ultrasound).
- •Severe heart rhythm disorders.
- •Angina unstable.
- •Recent Acute Coronary Syndrome.
- •Heart Shunt Right - Left.
- •Severe pulmonary arterial hypertension (PAH) (defined as PAH > 90 mmHg).
- •Acute or severe cardiac insufficiency stage 3 and 4
- •Pregnant woman and vulnerable patient population (persons deprived of administrative and / or judicial liberty, and persons under guardianship.
- •Mental disability of the subject making participation in the trial impossible.
结局指标
主要结局
Relevance of endoscopic elastosonography for description and characterization of digestive endometriosis lesions, using a ratio of elastonography.
时间窗: 36 months
Calculate the average of the endoscopic elastosonography ratios in order to establish the hardness of the endometriosic tissues invading the digestive tract. For each lesion, a ratio of elastosonography will be calculated, averaging three elastometric measurements taken during the examination.
Relevance of EUS contrast for description and characterization of digestive endometriosis lesions.
时间窗: 36 months
Determine the contrast agent intake, intensity, start time, and washout time, depending on the location, and the extent of the endometriosis lesion to the digestive tract. Using a scale of intensity of contrast intake (Weak, Moderate, Intense)
次要结局
- Correlation between elastosonography and EUS contrast for histological criteria.(36 months)
- Establish the safety of use of elastosonography and the endoscopy rectal ultrasound using contrast.(36 months)
- Correlation between elastosonography and EUS contrast for clinical criteria using visual analog scale of pain.(36 months)
- Surgical criteria(36 months)
- Correlation between elastosonography and EUS contrast for clinical criteria using , description of symptoms.(36 months)
- Correlation between elastosonography and EUS contrast for clinical criteria using scale of analgesic used.(36 months)
研究者
VANBIERVLIET
Head of endoscopy unit, Principal Investigator, Medical Doctorate, Physiology Doctorate
Société Française d'Endoscopie Digestive