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

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ClinicalTrials.gov Identifier: NCT03138954
Recruitment Status : Completed
First Posted : May 3, 2017
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
VANBIERVLIET, Société Française d'Endoscopie Digestive

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.

Condition or disease
Endometriosis, Rectum

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Place of Endoscopic Rectal Ultrasound With Elastosonography and Contrast in Diagnosis and Supported of Deep Pelvic Endometriosis With Bowel Involvement
Actual Study Start Date : May 21, 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Relevance of endoscopic elastosonography for description and characterization of digestive endometriosis lesions, using a ratio of elastonography. [ Time Frame: 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.

  2. Relevance of EUS contrast for description and characterization of digestive endometriosis lesions. [ Time Frame: 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)


Secondary Outcome Measures :
  1. Correlation between elastosonography and EUS contrast for clinical criteria using visual analog scale of pain. [ Time Frame: 36 months ]
    The first clinical criteria will be based on each patient's pain, using visual analog scale of pain, from the data collected from each patient by completing a questionnaire during the interview.

  2. Correlation between elastosonography and EUS contrast for clinical criteria using , description of symptoms. [ Time Frame: 36 months ]
    The second clinical criteria will be based on each patient's, type of symptoms. Using the data collected from each patient by completing a questionnaire during the interview.

  3. Correlation between elastosonography and EUS contrast for clinical criteria using scale of analgesic used. [ Time Frame: 36 months ]
    The third clinical criteria will be based on different types of drug therapy used for the pain. Using the data collected from each patient by completing a questionnaire during the interview.

  4. Correlation between elastosonography and EUS contrast for histological criteria. [ Time Frame: 36 months ]
    The histological criteria will be established, after anatomopathological analysis of the operative part, on the hardness of the lesions, and their vascularization.

  5. Surgical criteria [ Time Frame: 36 months ]
    The surgical criteria will be based on the type of surgery, its difficulty, and its possible complications according to Clavien d'Indo's classification.

  6. Establish the safety of use of elastosonography and the endoscopy rectal ultrasound using contrast. [ Time Frame: 36 months ]
    The safety of use of the elastosonography and the endoscopy rectal ultrasound using contrast will be established after statistical analysis of possible side effects attributable to the procedure.Number of participants with medical procedure -related adverse events as assessed by CTCAE v4.0



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with deep pelvic endometriosis and digestive impairment.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138954


Locations
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France
Hôpital L'Archet 2
Nice, France, 06202
Sponsors and Collaborators
Société Française d'Endoscopie Digestive
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Responsible Party: VANBIERVLIET, Head of endoscopy unit, Principal Investigator, Medical Doctorate, Physiology Doctorate, Société Française d'Endoscopie Digestive
ClinicalTrials.gov Identifier: NCT03138954    
Other Study ID Numbers: EEE2018
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis