Clinical trial NCT03138954: Endoscopic Rectal UltraSound With Elastosonography and Contrast in Deep Pelvic Endometriosis With Bowel Involvement
Official title: Place of Endoscopic Rectal Ultrasound With Elastosonography and Contrast in Diagnosis and Supported of Deep Pelvic Endometriosis With Bowel Involvement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis, Rectum
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with deep pelvic endometriosis and digestive impairment.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Relevance of endoscopic elastosonography for description and characterization of digestive endometriosis lesions, using a ratio of elastonography.
timeFrame: 36 months
measure: Relevance of EUS contrast for description and characterization of digestive endometriosis lesions.
timeFrame: 36 months
Secondary outcomes:
measure: Correlation between elastosonography and EUS contrast for clinical criteria using visual analog scale of pain.
timeFrame: 36 months
measure: Correlation between elastosonography and EUS contrast for clinical criteria using , description of symptoms.
timeFrame: 36 months
measure: Correlation between elastosonography and EUS contrast for clinical criteria using scale of analgesic used.
timeFrame: 36 months
measure: Correlation between elastosonography and EUS contrast for histological criteria.
timeFrame: 36 months
measure: Surgical criteria
timeFrame: 36 months
measure: Establish the safety of use of elastosonography and the endoscopy rectal ultrasound using contrast.
timeFrame: 36 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital L'Archet 2
Study officials:
References: