Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

18. september 2019 opdateret af: VANBIERVLIET, Société Française d'Endoscopie Digestive

Place of Endoscopic Rectal Ultrasound With Elastosonography and Contrast in Diagnosis and Supported of Deep Pelvic Endometriosis With Bowel Involvement

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Nice, Frankrig, 06202
        • Hopital L'Archet 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Women with deep pelvic endometriosis and digestive impairment.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relevance of endoscopic elastosonography for description and characterization of digestive endometriosis lesions, using a ratio of elastonography.
Tidsramme: 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.
36 months
Relevance of EUS contrast for description and characterization of digestive endometriosis lesions.
Tidsramme: 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)
36 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between elastosonography and EUS contrast for clinical criteria using visual analog scale of pain.
Tidsramme: 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.
36 months
Correlation between elastosonography and EUS contrast for clinical criteria using , description of symptoms.
Tidsramme: 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.
36 months
Correlation between elastosonography and EUS contrast for clinical criteria using scale of analgesic used.
Tidsramme: 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.
36 months
Correlation between elastosonography and EUS contrast for histological criteria.
Tidsramme: 36 months
The histological criteria will be established, after anatomopathological analysis of the operative part, on the hardness of the lesions, and their vascularization.
36 months
Surgical criteria
Tidsramme: 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.
36 months
Establish the safety of use of elastosonography and the endoscopy rectal ultrasound using contrast.
Tidsramme: 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
36 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Société Française d'Endoscopie Digestive

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. maj 2015

Primær færdiggørelse (Faktiske)

1. januar 2018

Studieafslutning (Faktiske)

1. januar 2018

Datoer for studieregistrering

Først indsendt

30. marts 2017

Først indsendt, der opfyldte QC-kriterier

29. april 2017

Først opslået (Faktiske)

3. maj 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EEE2018

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Endometriose, endetarm

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Myanmar

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner