Endoscopic Rectal UltraSound With Elastosonography and Contrast in Deep Pelvic Endometriosis With Bowel Involvement

Société Française d'Endoscopie Digestive

Status: Completed

Conditions: Endometriosis, Rectum

Study type: Observational

Funder types: Other

Identifiers

NCT03138954

EEE2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.