Endoscopic Rectal UltraSound With Elastosonography and Contrast in Deep Pelvic Endometriosis With… (NCT03138954) | Clinical Trial Compass
CompletedNot Applicable
Endoscopic Rectal UltraSound With Elastosonography and Contrast in Deep Pelvic Endometriosis With Bowel Involvement
France50 participantsStarted 2015-05-21
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
What they're measuring
1
Relevance of endoscopic elastosonography for description and characterization of digestive endometriosis lesions, using a ratio of elastonography.
Timeframe: 36 months
2
Relevance of EUS contrast for description and characterization of digestive endometriosis lesions.