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

NCT03138954 | Completed

• 1 other identifier: EEE2018
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis, Rectum

Outcome Measures

Primary Outcomes (2)

• Relevance of endoscopic elastosonography for description and characterization of digestive endometriosis lesions, using a ratio of elastonography.

  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.

  36 months

• Relevance of EUS contrast for description and characterization of digestive endometriosis lesions.

  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)

  36 months

Secondary Outcomes (6)

• Correlation between elastosonography and EUS contrast for clinical criteria using visual analog scale of pain.

  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

• Correlation between elastosonography and EUS contrast for histological criteria.

  36 months

• Surgical criteria

  36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with deep pelvic endometriosis and digestive impairment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

Study Sites (1)

Hôpital L'Archet 2

Nice, 06202, France

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of endoscopy unit, Principal Investigator, Medical Doctorate, Physiology Doctorate

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: May 3, 2017
• Study Start: May 21, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)