- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07657884
Assessment of the Usefulness of SMI (Superb Vascular Imaging) for the Characterisation of Pancreatic Cystic Tumours (IMAKYST) (IMAKYST)
A cystic lesion is an abnormal cavity formed within tissue or an organ, which may contain a liquid, semi-solid or gaseous substance.
There are different types of pancreatic cystic lesions: lesions that may become cancerous and completely benign lesions that do not require monitoring, such as serous cystadenomas (SCs) and pseudocysts.
Diagnostic difficulties mean that one in three patients with a SC undergoes unnecessary surgery with significant morbidity and mortality (risk of death). Currently, needle-based confocal laser endomicroscopy (nCLE) is the gold standard technique for the diagnosis of SC.
SC is a lesion characterised by an extensive network of small blood vessels present in all the cyst walls and throughout the cyst's peripheral capsule. SMI (Superb Vascular Imaging) is a new ultrasound mode that improves the visibility of blood flow in the vessels without the injection of contrast medium (a diagnostic agent used for certain medical imaging examinations, most often administered intravenously), unlike nCLE.
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 EUS Aplio i800 console (Canon-Olympus), which is CE marked.
To date, no data has been published on the potential of SMI to characterise and diagnose CS. This is why this clinical investigation is being conducted.
연구 개요
상세 설명
Pancreatic cysts are becoming increasingly common in the general population. They are most often discovered incidentally during cross-sectional abdominal imaging.
There are different types of pancreatic cystic lesions, each with distinct risks of progression. Lesions with the potential for malignant transformation are typically mucinous lesions (papillary intraductal mucinous neoplasms of the pancreas [PIMN] and mucinous cystic neoplasms [MCN]), formerly known as mucinous cystadenomas), whereas non-mucinous lesions (serous cystadenomas [SCs] and pseudocysts) are entirely benign and do not require monitoring.
SC typically presents as a solitary cyst with no communication with the Wirsung duct, appearing microcystic with central calcification. This typical appearance is not always present, and SC can mimic a mucinous lesion. In such cases, imaging and echoendoscopy findings are not discriminatory. Histological and biochemical analysis of the fluid obtained during cyst aspiration may be helpful, but the specificity is usually insufficient to make a definitive decision regarding the absence of surgery and the need for monitoring. These diagnostic difficulties mean that one in three patients with SC undergo unnecessary surgery, with significant morbidity and mortality.
There are currently two highly effective techniques for diagnosing SC:
- Endocystic microbiopsy, which has a diagnostic accuracy of nearly 100% but a high complication rate (around 10%). It is no longer recommended except in exceptional cases.
- Needle-based confocal laser endomicroscopy (nCLE), which has 100% specificity for the diagnosis of SC.
SC is a lesion characterised by intense microvascularisation present in all the cyst walls and throughout the entire peripheral capsule of the cyst. SMI is a new ultrasound modality capable of visualising microvascular flow without the need for contrast injection, unlike nCLE.
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 has been published on the potential of SMI for characterising and diagnosing SC. This is why this clinical investigation is being conducted.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Bertrand NAPOLEON, MD
- 전화번호: + 33 4 78 75 67 43
- 이메일: dr.napoleon@wanadoo.fr
연구 장소
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Lyon, 프랑스, 69008
- 모병
- Hôpital Privé Jean Mermoz
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연락하다:
- Bertrand NAPOLEON, MD
- 전화번호: + 33 4 78 75 67 43
- 이메일: dr.napoleon@wanadoo.fr
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patient referred for confocal microscopy (nCLE) assessment of a pancreatic cyst of unknown origin
- Patient with a cyst measuring more than 15 mm in diameter and at least one cyst cavity measuring ≥ 5 mm (to allow nCLE to be performed)
- Patient registered with or covered by the National Health Service
- French-speaking patient who has signed an informed consent form
Exclusion Criteria:
- Patient with calcifying chronic pancreatitis
- Presence of a communication with the main pancreatic duct on MRI or endoscopic ultrasound
- Patient whose lesion meets criteria for malignancy (tissue mass, metastases, ascites, vascular infiltration)
- Patient with a contraindication to endoscopic ultrasound-guided puncture (haemostatic disorder)
- Patient with a known allergy to fluorescein (used in nCLE)
- Pregnant woman
- Patient under legal guardianship: adults under guardianship, curatorship or other legal protection, or deprived of their liberty by judicial or administrative order
- Hospitalised patient without consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: SMI group
Intervention involves acquiring B-mode images of the pancreatic cyst using SMI
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B-mode imaging of pancreatic cysts with SMI using the new Aplio i800 EUS console (Canon-Olympus)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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SMI specificity
기간: Day 0
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SMI specificity is expressed as a percentage.
Specificity is defined as the number of true negatives (negative diagnoses in patients without SC) divided by the total number of patients without SC.
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Day 0
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-A00624-47
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
SMI imaging에 대한 임상 시험
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Nigde Omer Halisdemir University완전한
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Medical University of South CarolinaNational Institute of Nursing Research (NINR)완전한
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VA Office of Research and Development완전한
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GCS Ramsay Santé pour l'Enseignement et la Recherche아직 모집하지 않음
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French Cardiology SocietyInstitut National de la Santé Et de la Recherche Médicale, France완전한