Endoscopic Rectal UltraSound With Elastosonography and Contrast in Deep Pelvic Endometriosis With Bowel Involvement
Place of Endoscopic Rectal Ultrasound With Elastosonography and Contrast in Diagnosis and Supported of Deep Pelvic Endometriosis With Bowel Involvement
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Nice、フランス、06202
- Hopital L'Archet 2
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Relevance of endoscopic elastosonography for description and characterization of digestive endometriosis lesions, using a ratio of elastonography.
時間枠：36 months
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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.
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36 months
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Relevance of EUS contrast for description and characterization of digestive endometriosis lesions.
時間枠：36 months
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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)
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36 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Correlation between elastosonography and EUS contrast for clinical criteria using visual analog scale of pain.
時間枠：36 months
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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.
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36 months
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Correlation between elastosonography and EUS contrast for clinical criteria using , description of symptoms.
時間枠：36 months
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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.
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36 months
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Correlation between elastosonography and EUS contrast for clinical criteria using scale of analgesic used.
時間枠：36 months
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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.
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36 months
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Correlation between elastosonography and EUS contrast for histological criteria.
時間枠：36 months
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The histological criteria will be established, after anatomopathological analysis of the operative part, on the hardness of the lesions, and their vascularization.
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36 months
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Surgical criteria
時間枠：36 months
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The surgical criteria will be based on the type of surgery, its difficulty, and its possible complications according to Clavien d'Indo's classification.
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36 months
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Establish the safety of use of elastosonography and the endoscopy rectal ultrasound using contrast.
時間枠：36 months
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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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36 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EEE2018
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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