Assessment of SMI (Superb Microvascular Imaging) for Characterising the Endocystic Material of Papillary Intraductal Mucinous Pancreatic Tumours (PIMPT) (ENDOKYSMILE)
There are many types of pancreatic cysts, and papillary intraductal mucinous pancreatic tumours (PIMPTs) are among the most common.
PIMPTs carry a risk of progressing to a cancerous lesion. To assess this risk, the key examination involves performing an endoscopic ultrasound combined with an injection of a contrast agent called Sonovue.
Superb Microvascular Imaging (SMI) is a new ultrasound modality that enables the analysis of PIMPTs without the need for a Sonovue injection.
The Mermoz Endoscopy Centre will be equipped with an ultrasound console enabling SMI to be performed during an endoscopic ultrasound examination.
This technology is now available on the new EUS Aplio i800 console (Canon-Olympus), which bears the CE mark.
To date, no data have been published on the potential of SMI for analysing a PIMPT. This is why this clinical investigation is being conducted
調査の概要
状態
詳細な説明
Pancreatic cysts are becoming increasingly common in the general population. They are most often discovered incidentally during an imaging scan.
There are many types of pancreatic cystic lesions, but the most common are papillary intraductal mucinous pancreatic tumours (PIMPTs), serous cystadenomas (SCAs), mucinous cystic tumours (MCTs) (formerly known as mucinous cystadenomas), cystic neuroendocrine tumours, and solid and pseudopapillary tumours.
PIMPTs carry a risk of degeneration, which may arise from an initially benign wall-bound nodule (polyp) that can subsequently progress to a malignant lesion. The average rates of high-grade dysplasia/invasive carcinoma in surgical specimens of PIMPT from the secondary ducts and the main duct are 31% and 62% respectively. The presence of a wall-adherent nodule > 1 cm is a clear indication for pancreatic surgery to prevent neoplastic progression (or to treat it if it is already present within the nodule). However, PIMPTs also secrete mucus, which most often presents as a globule adhering to the wall, thus resembling a wall-adherent nodule.
The key examination for assessing a PIMPT is echoendoscopy, which enables the type of material present within the cyst to be characterised. The most sensitive standard Doppler technique (e-flow) is often unsuccessful (no visible vessels) or yields an inconclusive result, as the vessels present in the tissue nodules are very fine and have a very slow flow.
Currently, to distinguish mucus from a tissue nodule, an ultrasound contrast agent (Sonovue) is routinely used to detect microvascularisation. A tissue nodule takes up the contrast agent, whereas a mucus ball is avascular (no contrast uptake).
Superb Microvascular Imaging (SMI) is a new ultrasound mode that broadens the range of visible blood flow by revealing low-velocity microvascular flow. SMI is capable of visualising microvascular flow without the injection of contrast medium, unlike the current gold standard technique based on the injection of Sonovue.
The Mermoz Endoscopy Centre will be equipped with an ultrasound console enabling SMI to be performed during an echoendoscopy examination. This technology is now available on the new Aplio i800 EUS console (Canon-Olympus).
To date, no data have been published on the potential of SMI to characterise the endocystic material of PIMPTs. This is why this clinical investigation is being conducted.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Bertrand NAPOLEON, MD
- 電話番号:+ 33 4 78 75 67 43
- メール:dr.napoleon@wanadoo.fr
研究場所
-
-
-
Lyon、フランス、69008
- Hôpital privé Jean Mermoz
-
コンタクト:
- Bertrand NAPOLEON, MD
- 電話番号:+ 33 4 78 75 67 43
- メール:dr.napoleon@wanadoo.fr
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patient referred for an endoscopic ultrasound assessment of a PIMPT
- Patient with endocystic material of undetermined nature measuring 3 mm or more
- Patient registered with or covered by the social security scheme
- Patient who speaks French
- Patient who has signed an informed consent form
Exclusion Criteria:
- Patient whose lesion meets the criteria for malignancy (tissue mass, metastases, ascites, vascular infiltration)
- Patient for whom Sonovue is contraindicated
- Pregnant woman
- Vulnerable patient: an adult under guardianship, curatorship or other legal protection, or deprived of their liberty by a judicial or administrative decision
- Patient admitted to hospital without consent
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
- 主な目的:診断
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:SMI group
Imaging of endocystic material within PIMPT in SMI, using the new Aplio i800 EUS console (Canon-Olympus)
|
Imaging of endocystic material within PIMPT in SMI, using the new Aplio i800 EUS console (Canon-Olympus)
|
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 |
|---|---|---|
|
SMI sensitivity
時間枠:Day 0
|
Sensitivity is defined as the number of true positives (positive diagnoses in patients with a tissue nodule) divided by the total number of patients with a tissue nodule
|
Day 0
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
その他の研究ID番号
- 2026-A00625-46
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。